> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-gs-4528-in-adults-with-solid-tumors-38c9693c-970a-465e-9529-dff6b7fde32f > Record changed: 2026-10-13 # Study of GS-4528 in Adults With Solid Tumors NCT05840224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) Participants 182 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) Lead sponsor Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) Start date 2023-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) Number of sites 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Title and summary **Summary** The goals of this clinical study are to identify if GS-4528 alone or in combination with anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe to give to people alone or in combination with Anti-PD-1 Monoclonal Antibody. The primary objectives of this study are: \* To assess the safety and tolerability of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors. \* To identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Short title** Study of GS-4528 in Adults With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Official title** A Phase 1 Study to Evaluate the Safety and Tolerability of GS-4528 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Dates **Completion date** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **First posted** 2023-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Registry last updated** 2026-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Primary completion date** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Start date** 2023-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Size and sites **Participants** 182 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Planned participants** 182 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Number of sites** 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Lead sponsor** Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Identifiers **Registry ID** NCT05840224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **ClinicalTrials.gov ID** NCT05840224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Outcomes ### Primary outcomes 1. Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: First dose date up to 90 days post last dose (Up to 24 months) 2. Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) Timeframe: Day 1 up to 4 weeks 3. Maximum Tolerable Dose (MTD) of GS-4528 Timeframe: Day 1 up to 4 weeks ### Secondary outcomes 1. Pharmacokinetic (PK) parameter: Cmax of GS-4528 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody Timeframe: Predose on Day 1 and post dose up to end of treatment (EOT, Up to 24 months) Cmax is defined as the maximum observed concentration of drug. 2. PK parameter: Cmin of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody Timeframe: Predose on Day 1 and post dose up to EOT (Up to 24 months) Cmin is defined as the minimum observed concentration of drug. 3. PK parameter: AUC of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody Timeframe: Predose on Day 1 and post dose up to EOT (Up to 24 months) AUC is defined as the area under the concentration versus time curve. 4. Serum Concentrations of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody Timeframe: Predose on Day 1 and post dose up to EOT (Up to 24 months) 5. Percentage of Participants who Develop Antidrug Antibody (ADA) Against GS-4528 Timeframe: Predose on Day 1 and post dose up to 60 day follow-up (Up to 24 months) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Documented disease: - Phase 1a dose escalation and backfill cohorts; Phase 1b dose escalation: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy. - Phase 1a dose expansion: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy. - Eastern Cooperative Oncology Group performance status 0 or 1. - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. - Adequate organ function. - Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception. - Tissue requirements: - Phase 1a dose escalation, Phase 1a dose expansion, and Phase 1b dose escalation: Must provide pre-treatment adequate tumor tissue sample prior to enrolment. - Phase 1a backfill cohorts: Individuals must have fresh pre-treatment and on-treatment biopsy for biomarker analysis. - Life expectancy ≥ 3 months. Key Exclusion Criteria: - Positive serum pregnancy test or lactating female. - Prohibited concurrent anticancer therapy listed in the protocol. - Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: major surgery (<28 days), immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (< 14 days or < 5 half-lives whichever is shorter), hormonal therapy or other adjunctive therapy (< 14 days) or radiotherapy (< 21 days). - Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. - Diagnosis of immunodeficiency, either primary or acquired, or systemic steroid requirement of > 10 mg of prednisone or equivalent. - History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy. - History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment. - Concurrent active second malignancy. Note: Individuals with a history of malignancy that have been completely treated, with no evidence of active cancer for 2 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence are allowed to enroll. - Have known active central nervous system (CNS) metastases and/ or carcinomatous meningitis. - Significant cardiovascular disease. - Have active serious infection requiring antibiotics. - Have active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). - History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis). - Symptomatic ascites or pleural effusion. - Live vaccines within 28 days of initiation of investigational product(s). Note: Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Sites - The University of Washington/FHCCSeattle, United States - The Ottawa HospitalOttawa, Canada - University Health Network, Princess Margaret Cancer CentreToronto, Canada - Asan Medical CenterSeoul, South Korea - Severance Hospital, Yonsei University Health SystemsSeoul, South Korea - Samsung Medical CenterSeoul, South Korea - NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1Barcelona, Spain - Hospital Universitari Vall D'Hebron- Oncology ServiceBarcelona, Spain - START MADRID\_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases IMadrid, Spain - START MADRID\_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases IMadrid, Spain - Clinica Universidad de Navarra- Unidad Central de Ensayos ClinicosPamplona, Spain - Taichung Veterans General HospitalTaichung, Taiwan - National Taiwan University HospitalTaipei, Taiwan - Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical FoundationTaoyuan, Taiwan - St Bartholomew's HospitalLondon, United Kingdom - The Royal Marsden NHS Foundation TrustSutton, United Kingdom Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## References - Related resource (www.gileadclinicaltrials.com) Source: [www.gileadclinicaltrials.com](https://www.gileadclinicaltrials.com/study?nctid=NCT05840224) ### Other registry identifiers - 2022-502070-16 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05840224) ## Related records ### Drugs (1) - [Zimberelimab](https://trialight.com/data/asset/zimberelimab-0723178b-0f17-47bf-bdaa-1046f372b9d2.md) ### Lead sponsors (1) - [Gilead Sciences](https://trialight.com/data/company/gilead-sciences-dc2ce801-6c14-47ef-b8fc-217ce33be039.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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