focus areas
Tumor-intrinsic cell death Immune-mediated tumor killing Tumor-permissive microenvironment
zimberelimab (PD-1) domvanalimab (TIGIT) chemo
Sacituzumab govitecan (Trop-2) zimberelimab (PD-1) domvanalimab (TIGIT) chemo
zimberelimab (PD-1) domvanalimab (TIGIT) chemo
zimberelimab (PD-1) quemliclustat (CD73) chemo
zimberelimab (PD-1) quemliclustat (CD73) chemo
SG (Trop-2)
SG (Trop-2)
zimberelimab (PD-1) domvanalimab (TIGIT) quemliclustat (CD73)
SG (Trop-2)
zimberelimab (PD-1) etrumadenant (A2AR/A2BR) quemliclustat (CD73) chemo
Clinicaltrials.gov website. Accessed January 17, 2025. https://www.clinicaltrials.gov
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
ClinicalTrials.gov Identifier: NCT05568095
STAR-221: A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomaa
Study Design1
Patients
Locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma
N=1040
Endpoints
Primary Endpoint
Randomization
Endpoints
Zimberelimab + +
Domvanalimab A FOLFOX/CAPOXb
B Nivolumab + FOLFOX/CAPOXb
Key Eligibility Criteria1
Key Inclusion Criteria
• ≥18 years of age
• Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma
Key Exclusion Criteria
• Underlying medical or psychiatric conditions that, in the Investigator’s or Sponsor’s opinion, will make the administration of study-specified therapy hazardous, including but not limited to:
ILD, including history of ILD or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization
Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization
• ECOG PS of 0 or 1
STAR-221 is active, not recruiting.
• ≥1 measurable target lesion per RECIST v1.1
History of prior solid-organ transplantation, including allogenic bone marrow transplantation
Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial
• Known HER2+ tumor
• Known untreated, symptomatic, or actively progressing CNS (brain) metastases. Patients with leptomeningeal metastases are excluded from enrollment
• Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma
• Disease progression within 6 months of completion of neoadjuvant or adjuvant therapy
CAPOX, combination regimen of capecitabine plus oxaliplatin; CNS, central nervous system; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; FOLFOX, combination regimen of oxaliplatin, leucovorin, fluorouracil; GEJ, gastroesophageal junction; HER2, human epidermal growth factor receptor 2; ILD, interstitial lung disease; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; v, version.
References
1. Clinicaltrials.gov website. Accessed January 16, 2025. https://www.clinicaltrials.gov/study/NCT05568095
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
ClinicalTrials.gov Identifier: NCT03547973
TROPHY U-01: A Phase 2 Open-Label Study of Sacituzumab Govitecan in Patients with Unresectable
Locally Advanced/Metastatic Urothelial Cancer
Study Design1,2
Cohort 1: 2L+
Cohort 2: 2L+
• Patients with locally advanced or metastatic UC
• Progressed after prior platinum-based and/or CPI-based therapies
Primary readout completed
• Patients with locally advanced or metastatic UC ineligible for platinum-based therapy
• Progressed after prior CPI-based therapies
Primary readout completed
• Patients with locally advanced or metastatic UC who are CPI-naive
Cohort 3: 1L
N~827a Patients
Cohort 4:c 1L
• Progressed after prior platinum-based therapies
Primary readout completed
• Patients with metastatic or unresectable locally advanced UC
• Cisplatin-eligible and treatment naive
Cohort 6:c
7:
• Patients with metastatic or unresectable locally advanced UC
• Cisplatin-ineligible and treatment naive
• Patients with no prior systemic therapy for metastatic or unresectable locally advanced UC
+ Pembro 200 mg
Cohorts 1-4, 6, 7: Continue treatment until clinical progression, disease progression, or toxicity
Key Eligibility Criteria1
Key Inclusion Criteria
• ECOG PS of 0 or 1
• Adequate renal and hepatic function
• Adequate hematologic parameters without transfusional support
Endpoints1,2
Primary Endpoint
• Cohorts 1-4, 6, 7: ORRf
• Cohort 7: Safety and tolerability
Key Exclusion Criteria
• Active second malignancy
• Active CNS metastases and/or carcinomatous meningitis
• Active Hepatitis B or C
Key Secondary Endpoints
Cohorts 1-4, 6, 7:
• CBRf,g
• DORf,g
• PFSf,g
• OS
Cohorts 1-4, 6:
• Safety and tolerability
Cohorts 3, 4, 6, 7:
• ORRf,g
aCohort 5 has been canceled, effective December 2023. bSG 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle. cEnrollment complete. dSG and EV doses determined in Phase 1b. eArm 3 is optional dose optimization arm to evaluate SG at 1 dose level below the RP2D that may be enrolled based on the RP2D and the totality of emerging data from Cohort 7. fPer RECIST v1.1. gCohorts 3, 4, 6 & 7 will be evaluated by iRECIST v1.1. 1L, first line; 2L, second line; Ave, avelumab; Carbo, carboplatin; CBR, clinical benefit rate; Cis, cisplatin; CNS, central nervous system; CPI, checkpoint inhibitor; Dom, domvanalimab; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EV, enfortumab vedotin; Gem, gemcitabine; iRECIST, Modified RECIST v1.1 for Immune-Based Therapeutics; ORR, objective response rate; OS, overall survival; Pembro, pembrolizumab; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; RP2D, recommended phase 2 dose; SG, sacituzumab govitecan; UC, urothelial cancer; v, version; Zim, zimberelimab.
References
1. Clinicaltrials.gov website. Accessed January 17, 2025. https://www.clinicaltrials.gov/study/NCT03547973
2. Gilead Sciences Inc. Data on File. TROPHY U-01 protocol (Amendment 12). May 10, 2024.
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
ClinicalTrials.gov Identifier: NCT03964727
TROPiCS-03: A
Phase 2 Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic
Solid Tumors
Study Design1,2
Patients N~165
2L+ mNSCLC (SCC and adenocarcinoma)
s/p IO and platinum-based regimen
2L-4L mHNSCC
s/p IO and platinum-based regimena
2L-4L mEC
s/p IO and platinum-based regimena
2L mSCLC
s/p IO and platinum-based regimenb
Sacituzumab govitecan 10 mg/kg IV
DAYS 1 AND 8 OF 21-DAY CYCLE N ~ 30-40/COHORT
Signal seeking for POC
Continue enrollment to total N ~ 165/cohort
Treatment until PD or unacceptable toxicity
Expansion stage planned only for HNSCC, EC, and SCLC cohorts (if efficacy signal met in the POC stage)
Survival follow-up
aNo more than 3 prior lines of systemic treatment is allowed. bNo more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed).
Key Eligibility Criteria1,2
Key Inclusion Criteria
• ≥18 years of age
• ECOG PS of 0 or 1
• Histologically documented metastatic or locally advanced solid tumors (NSCLC, HNSCC, EC, and SCLC)
• Measurable disease by CT or MRI as per RECIST v1.1
• Adequate hepatic and renal function (CrCl ≥30 mL/min)
• Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
Endpoints
1,2
Primary Endpoint
• ORRb
Key Exclusion Criteria
TROPiCS-03 is active, not recruiting.
• Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Study Day 1
• Have not recovered (i.e., ≤Grade 1) from AEs due to a previously administered agent
• Have previously received topoisomerase I inhibitors
• Have an active second malignancy
• Have known active CNS metastases and/or carcinomatous meningitis
Secondary Endpoints
• ORRc
• DORc
• CBRb,c
• PFSb,c
bAs assessed by Investigator per RECIST v1.1. cAs assessed by BICR per RECIST v1.1.
• OS
• Safety
• PK & ADAs
1L, first line; 2L, second line; 4L, fourth line; ADA, anti-drug antibody; AE, adverse event; BICR, blinded independent central review; CBR, clinical benefit rate; CNS, central nervous system; CrCl, creatinine clearance; CT, computed tomography; DOR, duration of response; EC, endometrial cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; HNSCC, head and neck squamous cell carcinoma; IO, immuno-oncology; IV, intravenous; m, metastatic; MRI, magnetic resonance imaging; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PK, pharmacokinetics; POC, proof of concept; RECIST, Response Evaluation Criteria in Solid Tumors; SCC, squamous cell carcinoma; SCLC, small cell lung cancer; s/p, status post; v, version.
References
1. Clinicaltrials.gov website. Accessed January 17, 2025. https://www.clinicaltrials.gov/study/NCT03964727
2. Gilead Sciences, Inc. Data on File. Protocol IMMU-132-11 (Amendment 3). November 9, 2021
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
ClinicalTrials.gov Identifier: NCT05329766
EDGE-Gastric: A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignanciesa
Study Design1,2
Patients
Locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma
aIn collaboration with Arcus Biosciences. bSafety run-in cohort: Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 60 minutes in addition to FOLFOX chemotherapy via IV infusion Q2W. After safety evaluation of co-administered domvanalimab and zimberelimab, patients will be randomized 1:1 to A3 and A4. cZimberelimab ± Domvanalimab will be administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX IV infusion Q2W.
Key Eligibility Criteria1
Key Inclusion Criteria
• ≥18 years of age
• Patients with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator
• ECOG PS of 0 or 1
• ≥1 measurable target lesion per RECIST v1.1
• Adequate organ and marrow function
• Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing
Key Exclusion Criteria
EDGE-Gastric is active, not recruiting.
• Patients with underlying medical conditions that, in the Investigator’s or Sponsor’s opinion, will make the administration of investigational products hazardous
• Only for Cohort A: Known HER2+ tumor
• Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Patients with leptomeningeal metastases are excluded from enrollment
• Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody
• History of trauma or major surgery within 28 days prior to enrollment
Primary Endpoint
• ORRb
• Safety Endpoints1
bAs assessed by Investigator per RECIST v1.1.
Secondary Endpoints • ORR
OS
PFSb
DCR
DORb
ADAs
1L, first line; 2L, second line; ADA, anti-drug antibody; CPI, checkpoint inhibitor; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; FOLFOX, combination regimen of oxaliplatin, leucovorin, fluorouracil; GEJ, gastroesophageal junction; HER2, human epidermal growth factor receptor 2; ORR, objective response rate; OS, overall survival; PD-L1, programmed cell death ligand 1; PFS, progression-free survival; PK, pharmacokinetics; Q2W, every 2 weeks; Q4W, every 4 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; TIGIT, T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif (ITIM) domains; v, version.
References
1. Clinicaltrials.gov website. Accessed January 21, 2025. https://www.clinicaltrials.gov/study/NCT05329766
2. Arcus Biosciences. Data on File. EDGE-Gastric Protocol (Version 4.0). January 25, 2024.
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
ClinicalTrials.gov Identifier: NCT04660812
ARC-9: A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating The Efficacy and Safety of Etrumadenant Based Treatment Combinations in Patients With Metastatic Colorectal Cancera
Endpoints1
Primary Endpoint
• Cohort A and B: PFSb
• Cohort C: ORRb
• All Cohorts: Safety
Secondary Endpoints
• Cohorts A and B: ORRb, OSb
• All Cohorts: PK, ADAs, DORb, DCRb
ARC-9 is active, not recruiting.
Key Eligibility Criteria1
Key Inclusion Criteria
• ≥18 years of age
• Histologically confirmed mCRC
• ≥1 measurable lesion per RECIST v1.1
• ECOG PS of 0 or 1
• Life expectancy ≥3 months
• Adequate hematologic and end-organ function
• Negative HIV, Hep B and Hep C antibody testing
Inclusion Criteria for Cohort A
• Disease progression following no more than one prior line of treatment for mCRC that consisted of oxaliplatin or irinotecan containing chemotherapy in combination with a biologic agent
Inclusion Criteria for Cohort B
• Disease progression during or following no more than two separate lines of treatment for mCRC that consisted of oxaliplatin, and irinotecan containing chemotherapy in combination with a biologic agent
Continued on next page
2L, second line; 3L third line; ADA, anti-drug antibody; Bev, bevacizumab; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; Hep, hepatitis; HIV, human immunodeficiency virus; mCRC, metastatic colorectal cancer; mFOLFOX-6, modified FOLFOX-6 regimen (5-fluorouracil, leucovorin, and oxaliplatin); ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; Quemli, quemliclustat; RECIST, Response Evaluation Criteria in Solid Tumors; v, version; Zim, zimberelimab.
Reference
1. Clinicaltrials.gov website. Accessed January 21, 2025. https://www.clinicaltrials.gov/study/NCT04660812
2. Cecchini M, et al. Poster presentation at ASCO GI Virtual Congress 2021. Poster TPS150. January 15-17, 2021.
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
Key
Eligibility Criteria (cont’d)1
Key Exclusion Criteria
• Previous anticancer treatment within 4 weeks prior to initiation of study treatment
• Prior allogeneic stem cell or solid organ transplant
• Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
• Use of any live vaccines against infectious diseases within 28 days of first dose.
• Symptomatic, untreated, or actively progressing CNS metastases
• Current treatment with anti-viral therapy for HBV
• Structurally unstable bone lesions suggesting impending fracture
• History of leptomeningeal disease
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
• History of malignancy other than colorectal cancer within 2 years prior to screening, except for malignancies such as non-melanoma skin carcinoma or ductal carcinoma in situ
• Active tuberculosis
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiating study treatment
• Severe infection within 4 weeks (28 days) prior to initiation of study treatment
• Significant cardiovascular disease, unstable or new onset of angina within 3 months prior to initiation of treatment, or myocardial infarction within 6 months prior to study treatment or unstable arrhythmia
• Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for major surgical procedure during the study
Key Eligibility Criteria (cont’d)1
Key Exclusion Criteria (cont’d)
• Evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)
• Prior treatment with an agent targeting the adenosine pathway
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain Barré syndrome, or multiple sclerosis
Exclusion Criteria for Cohorts A and B
ARC-9 is active, not recruiting.
• Prior treatment with immune checkpoint blockade therapies including anti-cytotoxic T lymphocyteassociated protein-4, and anti-PD-(L)1 therapeutic antibodies
• Mutation in the BRAF oncogene. Patients with unknown BRAF status will be required to undergo testing at a local laboratory and provide results at screening
CNS, central nervous system; CT, computed tomography; HBV, hepatitis B virus; IV, intravenous; PD-(L)1, programmed cell death (ligand) 1.
Reference
1. Clinicaltrials.gov website. Accessed January 21, 2025. https://www.clinicaltrials.gov/study/NCT04660812
2. Cecchini M, et al. Poster presentation at ASCO GI Virtual Congress 2021. Poster TPS150. January 15-17, 2021.
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
ClinicalTrials.gov Identifier: NCT04104672
A Phase 1 Study to Evaluate the Safety and Tolerability of Quemliclustat Combination Therapy in Patients With Gastrointestinal Malignanciesa
Study Design
Patients N=195
Cohort A
1L mPDAC
Dose escalation COMBINATION THERAPY
Quemliclustat
Gemcitabine/ nab-paclitaxel Zimberelimab
Cohort B
2L mPDAC
Cohort C
1L mPDAC
Dose expansion COMBINATION THERAPY
Quemliclustat + + Zimberelimab Gemcitabine/ nab-paclitaxel
Cohort D
1L mPDAC
aIn collaboration with Arcus Biosciences.
Quemliclustat + + Zimberelimab Gemcitabine/ nab-paclitaxel
Quemliclustat + + Zimberelimab Gemcitabine/ nab-paclitaxel + Quemliclustat Gemcitabine/nab-paclitaxel + Quemliclustat Gemcitabine/nab-paclitaxel
Endpoints
Primary Endpoint
• TEAEs
• DLTs
Secondary Endpoints
Key Eligibility Criteria
Key Inclusion Criteria
• Histologically or cytologically confirmed mPDAC
• Naïve to any prior treatment, including chemotherapy, biological therapy, or targeted therapy for metastatic disease
Prior adjuvant therapy (including chemotherapy and/ or radiotherapy) for PDAC is permitted if neoadjuvant or adjuvant therapy was completed ≥6 months prior to study enrollment. Prior adjuvant therapy may include nab-paclitaxel or gemcitabine
Patients initially diagnosed with locally advanced
bPer RECIST v1.1.
pancreatic cancer who have undergone chemotherapy then resection and had no evidence of disease are eligible if relapse of metastatic disease has occurred and if the last dose of chemotherapy was received >6 months before study entry
Continued on next page
1L, first line; 2L, second line; ADA, anti-drug antibody; DCR, disease control rate; DLT, dose limiting toxicity; DOR, duration of response; m, metastatic ORR, overall response rate; OS, overall survival; PDAC, pancreatic ductal adenocarcinoma; PFS, progression-free survival; PK, pharmacokinetics; RECIST, Response Evaluation Criteria in Solid Tumors; TEAE, treatment emergent adverse event; v, version.
Reference
Clinicaltrials.gov website. Accessed January 21, 2025. https://www.clinicaltrials.gov/study/NCT04104672
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
Continued from previous page
Key Eligibility Criteria (cont’d)
Key Inclusion Criteria (cont’d)
• ≥1 measurable lesion per RECIST v1.1. The measurable lesion must be outside of a radiation field if the patient received prior radiation
• ECOG PS of 0 or 1
• Confirmation that an archival tissue sample is available; if not, a new biopsy of a tumor must be obtained
• Prior radiation therapy for metastatic disease must have been completed
• Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses >10 mg/day prednisone or equivalent) must be discontinued ≥2 weeks (14 days) before investigational product administration. Physiologic doses of corticosteroids (≤10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤3 days) may be permitted
• Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed ≥4 weeks before investigational product administration
• Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative RNA; qualitative), and HIV-1 and HIV-2 antibody at screening
• Adequate organ and marrow function
Key Eligibility Criteria
(cont’d)
Key Exclusion Criteria
• Significant cardiovascular disease (NYHA Class III-IV), myocardial infarction or cerebrovascular accident within 12 months of the first dose of investigational agent or history of arterial thromboembolic event, uncontrolled hypertension, unstable arrhythmia, or unstable angina within 3 months or venous thromboses within 1 month of the first dose of investigational agent
• Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Patients with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
• Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
• Has not recovered (i.e., ≤Grade 1 or baseline) from a non-hematologic AE due to a previously administered agent, except ≤Grade 2 alopecia or ≤Grade 2 neuropathy
AE, adverse event; ECOG PS, Eastern Cooperative Oncology Group performance status; HIV, human immunodeficiency virus; NYHA, New York Heart Association; RECIST, Response Evaluation Criteria in Solid Tumors; RNA, ribonucleic acid; v, version.
Reference Clinicaltrials.gov website. Accessed January 21, 2025. https://www.clinicaltrials.gov/study/NCT04104672
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
ClinicalTrials.gov Identifier: NCT06486441
ASCENT-GYN-01 (GOG-3104/ENGOT-en26):
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-(L)1 Immunotherapya
Study Design
Patients
2L+ mEC
N~520
Endpoints
Primary Endpoints
• PFSb
C1
Randomization
C2
Sacituzumab govitecan 10 mg/kg IV DAY 1 AND DAY 8 OF 21-DAY CYCLE
TREATMENT OF PHYSICIAN’S CHOICE OR Doxorubicin 60 mg/m2 IV DAY 1 OF 21-DAY CYCLE
Paclitaxel 80 mg/m2 IV DAY 1 , 8, AND 15 OF 28-DAY CYCLE
Key Secondary Endpoints
• ORRb,c
• PFSc
• DORb,c
• CBRb,c
• Safety and tolerability
• PROs/QoL
• OS aIn collaboration with the Gynecologic Oncology Group (GOG) Foundation and the European Network of Gynaecological Oncological Trial Groups (ENGOT). bAs assessed by BICR per RECIST v1.1. cAs assessed by Investigator per RECIST v1.1.
Key Eligibility Criteria
Key Inclusion Criteria
• ≥18 years of age
• Documented evidence of recurrent/persistent EC (endometrial carcinoma or carcinosarcoma)
• Up to 3 prior lines of systemic therapy for EC, including systemic platinum-based chemotherapy and anti-PD(L)1 therapy, either in combination or separately
• Eligible for treatment with either doxorubicin or paclitaxel as determined by the Investigator
• Radiologically evaluable disease (either measurable or nonmeasurable) by CT or MRI per RECIST v1.1
• ECOG PS of 0 or 1
• Adequate organ function
Key Exclusion Criteria
• Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded
• Patients who are candidates for curative-intent therapy at the time of study enrollment
• Patients eligible for rechallenge with platinum-based chemotherapy as determined by the Investigator
• Received any prior treatment with a Trop-2-directed ADC
• Have an active second malignancy
• Have an active serious infection requiring systemic antimicrobial therapy
• Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or gastrointestinal perforation within 6 months prior to randomization
2L, second line; ADC, antibody-drug conjugate; BICR, blinded independent central review; C, cohort; CBR, clinical benefit rate; CT, computed tomography; DOR, duration of response; EC, endometrial cancer; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IV, intravenous; MRI, magnetic resonance imaging; OS, overall survival; ORR, objective response rate; PD-(L)1, programmed cell death (ligand) 1; PFS, progression-free survival; PRO, patient-reported outcome; QoL, quality of life; RECIST, Response Evaluation Criteria in Solid Tumors; Trop-2, trophoblast cell-surface antigen 2; v, version.
Reference
Clinicaltrials.gov website. Accessed January 21, 2025. https://www.clinicaltrials.gov/study/NCT06486441
The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
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