NCT05840224进行中（未招募）1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 182
- 试验地点
- 16
- 主要终点
- Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab)
Experimental
Participants will receive escalating doses of GS-4528 in combination with anti-PD1 monoclonal antibody (zimberelimab) to determine the maximum tolerated dose of GS-4528 as a combination therapy.
干预措施: GS-4528 (Biological)
Phase 1a: GS-4528 Monotherapy Dose Expansion
Experimental
Participants will receive GS-4528 monotherapy at the dose determined in the escalation phase.
干预措施: GS-4528 (Biological)
Phase 1a: GS-4528 Monotherapy Dose Escalation
Experimental
Participants will receive escalating doses of GS-4528 monotherapy to determine the maximum tolerated dose.
干预措施: GS-4528 (Biological)
Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab)
Experimental
Participants will receive escalating doses of GS-4528 in combination with anti-PD1 monoclonal antibody (zimberelimab) to determine the maximum tolerated dose of GS-4528 as a combination therapy.
干预措施: Zimberelimab (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: First dose date up to 90 days post last dose (Up to 24 months)
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
时间窗: Day 1 up to 4 weeks
Maximum Tolerable Dose (MTD) of GS-4528
时间窗: Day 1 up to 4 weeks
次要结局
- PK parameter: AUC of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody(Predose on Day 1 and post dose up to EOT (Up to 24 months))
- Percentage of Participants who Develop Antidrug Antibody (ADA) Against GS-4528(Predose on Day 1 and post dose up to 60 day follow-up (Up to 24 months))
- PK parameter: Cmin of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody(Predose on Day 1 and post dose up to EOT (Up to 24 months))
- Serum Concentrations of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody(Predose on Day 1 and post dose up to EOT (Up to 24 months))
- Pharmacokinetic (PK) parameter: Cmax of GS-4528 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody(Predose on Day 1 and post dose up to end of treatment (EOT, Up to 24 months))
研究者
研究点 (16)
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