For more information on the studies in this booklet, please contact GileadClinicalTrials@gilead.com
Last updated 04/25
Unmet Need in Breast Cancers
Approximately 13.1% of women in the US will be diagnosed with breast cancer at some point during their lifetime.1 There were 310,720 estimated new cases in the US in 2024.1 Breast cancer can be divided into several subtypes based on the presence of hormone or HER2 receptors.2 Treatment varies based on the specific breast cancer subtype at diagnosis.3
HER2, human epidermal growth factor receptor 2.
1. NCI. SEER – Cancer Stat Facts. Accessed April 15, 2025. Available at: https://seer.cancer.gov/statfacts/html/. 2. NCI. SEER – Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed April 15, 2025. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. 3. NCI. Breast Cancer Treatment (PDQ®)–Patient Version. Accessed April 15, 2025. Available at: https://www.cancer.gov/types/breast/patient/breast-treatment-pdq#section/all. For more information on the studies in this booklet, please visit gileadclinicaltrials.com
Unmet Need in GYN Cancers
In the US, uterine cancer is the ninth most common cancer, with an estimated 67,880 new cases and 13,250 deaths in 2024.1 Endometrial cancer (EC), the most common type of uterine cancer, has the highest prevalence and mortality among GYN cancers in the US.2-4 Although early-stage EC has a favorable prognosis, managing recurrent and metastatic disease remains a challenge. Median survival for patients with distant recurrent EC is under one year, and the death rate for Black women is nearly double that of other races.1,5
EC, endometrial cancer; GYN, gynecologic.
1. NCI. SEER – Cancer Stat Facts. Accessed April 15, 2025. Available at: https://seer.cancer.gov/statfacts/html/. 2. ACS. Cancer Facts & Figures. 2024. Accessed April 23, 2025. Available at: https://www.cancer.org/content/dam/ cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figuresacs.pdf. 3. Johnson CR, et al. JCO. 2024;42:5616–5616. 4. Mahdy H, et al. Endometrial Cancer. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available at: https://www.ncbi.nlm.nih.gov/books/ NBK525981/. 5. Heffernan K, et al. Gynecol Oncol. 2022;166:317–325.
For more information on the studies in this booklet, please visit gileadclinicaltrials.com
Breast/GYN trials by line of therapy
Adjuvant
2L-4L
ASCENT-GYN-01c
EVER-132-003 Cervical cancer cohort Cervical Ph 2
aIn collaboration with Alliance Foundation Trials, LLC. and the National Surgical Adjuvant Breast and Bowel Project Foundation, Inc. bIn collaboration with Merck. cIn collaboration with the Gynecologic Oncology Group (GOG) Foundation, the European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT).
1L, first line; 2L, second line; 4L, fourth line; BC, breast cancer; chemo, chemotherapy; GYN, gynecologic; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; m, metastatic; PD-(L)1, programmed cell death (ligand) 1; Ph, phase; SG, Sacituzumab govitecan; TNBC, triplenegative breast cancer; Trop-2, trophoblast cell-surface antigen 2.
molecular combinations and scientific focus
scientific focus areas
molecules
SG
SG
SG
SG
SG (Trop-2)
Tumor-intrinsic cell death
Immune-mediated tumor killing
Tumor-permissive microenvironment
Clinicaltrials.gov website. April 10, 2025. https://www.clinicaltrials.gov.
The safety and efficacy of investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
SG (Trop-2) pembrolizumab (PD-1)
pembrolizumab (PD-1)
sacituzumab govitecan (SG) (Trop-2)
(Trop-2)
(Trop-2)
(Trop-2)
(Trop-2)
Key Eligibility Criteria1
Key Inclusion Criteria
• ≥18 years of age
• ECOG PS of 0 or 1
• Adequate organ function
• Adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery
• Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue
• Patients must have received appropriate radiotherapy and have recovered prior to starting study treatment
Key Exclusion Criteria
• Stage IV breast cancer as well as history of any prior ipsilateral or contralateral invasive breast cancer
• Prior treatment with another stimulatory or coinhibitory T-cell receptor agent, prior treatment with any HER2directed agent, prior or concurrent endocrine therapy
• Evidence of recurrent disease following preoperative therapy and surgery
• Prior treatment with topoisomerase 1 inhibitors or ADCs containing a topoisomerase inhibitor
• Myocardial infarction within 6 months of enrollment or history of serious ventricular arrhythmia or LVEF <50%
• Active serious infection requiring anti-microbial treatment
Endpoints1
Primary Endpoint
• iDFS
Secondary Endpoints
• OS
• dDFS
• Safety
• PROs/QoL
• RFS
aIn collaboration with Alliance Foundation Trials, LLC. and the National Surgical Adjuvant Breast and Bowel Project Foundation, Inc.
ADC, antibody-drug conjugate; ASCO, American Society of Clinical Oncology; BID, twice daily; CAP, College of American Pathologists; dDFS, distant disease-free survival; ECOG PS, Eastern Cooperative Oncology Group performance status; ER, estrogen receptor; gBRCA, germline breast cancer gene; HER2, human epidermal growth factor receptor 2; iDFS, invasive disease-free survival; IV, intravenous; LVEF, left ventricular ejection fraction; OS, overall survival; PD-(L)1, programmed cell death (ligand) 1; PO, orally; PR, progesterone receptor; PRO, patient-reported outcome; QoL, quality of life; RFS, recurrence-free survival; RoW, rest of the world; TNBC, triple-negative breast cancer; vs, versus.
References
1. Clinicaltrials.gov website. Accessed April 10, 2025. https://www.clinicaltrials.gov/study/NCT05633654.
2. Tolaney SM, et al. Poster presentation at ASCO 2023. Chicago IL, June 2-6, 2023. Poster TPS619.
The safety and efficacy of investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
Key Eligibility Criteria1,2
Key Inclusion Criteria
• ≥18 years of age
• ECOG PS of 0 or 1
• Adequate organ function
• Patients whose tumors are PD-L1- at screening. Alternatively, patients whose tumors are PD-L1+ at screening will be eligible if they received an antiPD-(L)1 (i.e., checkpoint inhibitor) in the adjuvant or neoadjuvant setting
• ≥6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence
Key Exclusion Criteria
• Active CNS metastases and/or carcinomatous meningitis
• No prior anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
• Previously received topoisomerase 1 inhibitors or ADCs containing a topoisomerase inhibitor
• Active second malignancy
Endpoints1,2
Primary Endpoint
• PFSc
Secondary Endpoints
• OS
• ORRc • DORc • TTRc
• PROs/QoL • Safety
aPatients with previously untreated, locally advanced, inoperable, or metastatic triple-negative breast cancer whose tumors do not express PD-L1 or patients whose tumors do express PD-L1 previously treated with anti-PD-(L)1 agents in the early setting. bCrossover to SG in eligible patients allowed after BICR-verified disease progression.2 cBy BICR using RECIST v1.1.
1L, first line; ADC, antibody-drug conjugate; AUC, area under the curve; BICR, blinded independent central review; C, cohort; CNS, central nervous system; CPS, combined positive score; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenous; ORR, objective response rate; OS, overall survival; PD-(L)1, programmed cell death (ligand) 1; PFS, progression-free survival; PRO, patientreported outcome; QoL, quality of life; RECIST, Response Evaluation Criteria in Solid Tumors; SG, sacituzumab govitecan; TNBC, triple-negative breast cancer; TTR, time to response; v, version.
References
1. Clinicaltrials.gov website. Accessed April 10, 2025. https://www.clinicaltrials.gov/study/NCT05382299.
2. Bardia A, et al. Poster presentation at ESMO 2022. Paris, September 9-13, 2022. Poster 275TiP.
The safety and efficacy of investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
ASCENT-04: A Randomized, Open-Label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1a ClinicalTrials.gov Identifier: NCT05382286
Study Design1,2
Pembrolizumabb 200 mg IV
DAY 1 OF A 21-DAY CYCLE
Patients
Previously untreated, locally advanced, inoperable, or metastatic TNBC
N=443
Pembrolizumabb 200 mg IV
DAY 1 OF A 21-DAY CYCLE
Enrollment1,2
Study Population 1L mTNBC
• Previously untreated, locally advanced, inoperable, or de novo metastatic TNBC
• PD-L1+ by 22C3 CPS ≥10
Not recruiting
Sacituzumab govitecan 10 mg/kg IV
DAY 1 AND DAY 8 OF 21-DAY CYCLE
TREATMENT OF PHYSICIAN’S CHOICE
Gemcitabine 1000 mg/m2 + Carboplatin AUC 2 IV
DAY 1 AND DAY 8 OF 21-DAY CYCLE
Paclitaxel 90 mg/m2 IV
DAY 1, 8, AND 15 OF 28-DAY CYCLE
nab-Paclitaxel 100 mg/m2 IV
DAY 1, 8, AND 15 OF 28-DAY CYCLE
Continue treatment until BICR-verified disease progression or unacceptable toxicity
• ≥6 months since treatment in curative setting
• Prior anti-PD-(L)1 use allowed in the curative setting
• PD-L1 and TNBC status centrally confirmed
Key Eligibility Criteria1,2
Key Inclusion Criteria
• ≥18 years of age
• ECOG PS of 0 or 1
• Adequate organ function
• Patients who have not received previous systemic therapy for advanced disease and whose tumors are PD-L1+ at screening. Patients presenting with de novo mTNBC are eligible
• ≥6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence
Key Exclusion Criteria
• Active CNS metastases and/or carcinomatous meningitis
• No prior systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
• Previously received topoisomerase 1 inhibitors or ADCs containing a topoisomerase inhibitor
• Active second malignancy
Endpoints1
Primary Endpoint
• PFSd
Secondary Endpoints
• OS
• ORRd
• DORd
• TTRd
• PROs/QoL
• Safety
aIn collaboration with Merck. bMaximum 35 cycles of pembrolizumab. cCrossover to SG in eligible patients allowed after BICR-verified disease progression.2 dBy BICR using RECIST v1.1.
1L, first line; ADC, antibody-drug conjugate; AUC, area under the curve; BICR, blinded independent central review; CNS, central nervous system; CPS, combined positive score; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenous; m, metastatic; ORR, objective response rate; OS, overall survival; PD-(L)1, programmed cell death (ligand) 1; PFS, progression-free survival; PRO, patientreported outcome; QoL, quality of life; RECIST, Response Evaluation Criteria in Solid Tumors; TNBC, triple-negative breast cancer; TTR, time to response; v, version.
References
1. Clinicaltrials.gov website. Accessed April 10, 2025. https://www.clinicaltrials.gov/study/NCT05382286.
2. Tolaney SM, et al. Poster presentation at ESMO 2022. Paris, September 9-13, 2022. Poster 276TiP.
The safety and efficacy of investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
ASCENT-07: A Randomized, Open-Label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s
Study Design1,2
Patients Not recruiting
Choice in Patients With HR+/HER2- (HER2 IHC0 or HER2low [IHC 1+, IHC 2+/ISH-]), Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy ClinicalTrials.gov Identifier: NCT05840211
Sacituzumab govitecan 10 mg/kg IV DAY 1 AND DAY 8 OF 21-DAY CYCLE
HR+/HER2-, inoperable, locally advanced, or metastatic BC who have received ET N~654
Enrollment1,2
Randomization
TREATMENT OF PHYSICIAN’S CHOICE
Paclitaxel 80 mg/m2 IV
DAY 1, 8, AND 15 OF 28-DAY CYCLE
nab-Paclitaxel 100 mg/m2 IV
DAY 1, 8, AND 15 OF 28-DAY CYCLE
Capecitabine 1000 to 1250 mg/m2 BID PO
DAYS 1 THROUGH 14 FOLLOWED BY 7 DAY REST PERIOD OF A 21-DAY CYCLE
Patients must have 1 of the following:
• PD on ≥2 previous lines of ET ± a targeted therapy in the metastatic setting
Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting
• PD within 6 months of starting first-line ET ± CDK 4/6i in the metastatic setting
• Disease recurrence while on the first 24 months of starting adjuvant ET with CDK4/6i and if the patient is no longer a candidate for additional ET in the metastatic setting
Key Eligibility Criteria1
Key Inclusion Criteria
• ≥18 years of age
• Must have adequate tissue sample preferably from locally recurrent or metastatic site
• Documented evidence of HR+ mBC confirmed with most recently available tumor biopsy from a locally recurrent or metastatic site
• Documented evidence of HER2- status
• Documented PD by CT or MRI after most recent therapy per RECIST v1.1 criteria
• Candidate for first chemotherapy in the locally advanced or metastatic setting and eligible for capecitabine, nab-paclitaxel, or paclitaxel
Endpoints1
Primary Endpoint
• PFSa
Secondary Endpoints
• OS
• ORRa,b
• Patients may have received prior targeted therapy, including but not limited to PI3Ki (for those with PIK3CA mutations) or mTOR inhibitors. However, patients can no longer be candidates for additional endocrine treatment with or without targeted therapies
• ECOG PS of 0 or 1
Key Exclusion Criteria
• PD within 6 months of completing (neo)adjuvant chemotherapy
• Locally advanced mBC (Stage IIIc) in patients who are candidates for curative intent therapy
• Prior treatment containing a chemotherapeutic agent targeting topoisomerase I or any prior treatment with a Trop-2-directed ADC
• PFSb
• DORa,b
• Safety
• PROs/QoL
aBy BICR using RECIST v1.1. bBy Investigator using RECIST v1.1
ADC, antibody-drug conjugate; BC, breast cancer; BICR, blinded independent central review; BID, twice daily; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CT, computed tomography; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ET, endocrine therapy; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IHC, immunohistochemistry; ISH, in situ hybridization; IV, intravenous; m, metastatic; MRI, magnetic resonance imaging; mTOR, mammalian target of rapamycin; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PI3Ki, phosphatidylinositol 3-kinase inhibitor; PO, orally; PRO, patient-reported outcome; QoL, quality of life; RECIST, Response Evaluation Criteria in Solid Tumors; Trop-2, trophoblast cell-surface antigen 2; v, version.
References
1. Clinicaltrials.gov website. Accessed April 10, 2025. https://www.clinicaltrials.gov/study/NCT05840211.
2. Rugo HS, et al. Poster presentation at SABCS 2023. San Antonio, TX. December 5-9, 2023. Poster PO1-05-09.
The safety and efficacy of investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
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 ClinicalTrials.gov Identifier: NCT06486441
Study Design
Sacituzumab govitecan 10 mg/kg IV DAY 1 AND DAY 8 OF 21-DAY CYCLE
Patients 2L+ mEC N~520 C2
Randomization
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
Endpoints
Primary Endpoints
• PFSb
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, the European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT). 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 April 10, 2025. https://www.clinicaltrials.gov/study/NCT06486441
The safety and efficacy of 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=227
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
Signal seeking for POC
Continue to total enrollment
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 Criteria
1,2
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
• ORRc
Key Exclusion Criteria
• 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
• ORRd
• DORd
• CBRc,d
cAs assessed by Investigator per RECIST v1.1. dAs assessed by BICR per RECIST v1.1.
• PFSc,d
• 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 April 10, 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 investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
Key Eligibility Criteria
Key Inclusion Criteria
• ≥18 years of age
• ECOG PS of 0 or 1
• Histologically documented metastatic or locally advanced solid tumors (upper GI, cervical, lung)
Cervical cancer that was refractory or intolerant to platinum-based and taxane-based chemotherapy
• Measurable disease by CT or MRI as per RECIST v1.1
• Availability of archival tumor tissue or newly acquired biopsy (unstaining tumor slides, recommended from metastasis sites)
• Adequate bone marrow, hepatic and renal function
• Recovered from all prior treatment-related toxicities to Grade 1 or less by NCI-CTCAE v5.0 (except alopecia or peripheral neuropathy that may be Grade 2 or less)
• Patients must have completed all prior cancer treatments ≥2 weeks prior to the first dose including chemotherapy, radiotherapy and major surgery. Prior antibody treatment for cancer must have been completed ≥3 weeks prior to the first dose
• Patients must have ≥3-month life expectancy
Key Exclusion Criteria
• Previous treatment with topoisomerase I inhibitors as a free form or as other formulations
• Previous treatment with Trop-2 targeted therapy
• History of or current CNS metastases
• Known additional malignancy within 3 years prior to enrollment with the exception of curatively treated basal cell carcinoma of the skin, SCC of the skin and/or curatively resected in situ cancers
• HIV positive
• Active hepatitis B virus or hepatitis C virus infection
• Known history of unstable angina, myocardial infarction, or chronic heart failure present within 6 months of first dose or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy or left ventricular ejection fraction <50%
• Infection requiring systematic antibiotic use within 1 week of the first dose
• High dose systemic corticosteroids within 2 weeks prior to the first dose (however, low dose corticosteroids ≤10 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks)
• Patients who have received a live vaccine within 30 days of first dose
ADA, anti-drug antibody; CT, computed tomography; CNS, central nervous system; CTCAE, Common Terminology Criteria for Adverse Events; DCR, disease control rate; DOR, duration of response; ECOG PS, ECOG PS, Eastern Cooperative Oncology Group performance status; GEJ, gastroesophageal junction; GI, gastrointestinal; HIV, human immunodeficiency virus; IV, intravenous; MRI, magnetic resonance imaging; NCI, National Cancer Institute; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; SCC, squamous cell carcinoma; Trop-2, trophoblast cell-surface antigen 2; v, version.
Reference Clinicaltrials.gov website. Accessed April 17, 2025. https://clinicaltrials.gov/study/NCT05119907.
The safety and efficacy of investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.
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