A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-C0979 in Patients With Selected Advanced Solid Tumors
概览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- BeOne Medicines
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
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
- •Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- •Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- •Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
- •Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.
- •Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Participants must have adequate organ function.
排除标准
- •Prior treatment with any ADAM9-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 inhibitor as payload.
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Phase 1a: Monotherapy Dose Escalation
Participants will receive increasing doses of BG-C0979 as monotherapy.
干预措施: BG-C0979 (Drug)
Phase 1b, Part B: Combination Therapy Expansion
Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.
干预措施: Tislelizumab (Drug)
Phase 1a: Monotherapy Safety Expansion
Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion.
干预措施: BG-C0979 (Drug)
Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion
Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a.
干预措施: BG-C0979 (Drug)
Phase 1b, Part B: Combination Therapy Expansion
Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.
干预措施: BG-C0979 (Drug)
结局指标
主要结局
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
时间窗: Up to approximately 24 months
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results.
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy
时间窗: Up to approximately 10 months
MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])
时间窗: Up to approximately 10 months
The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available.
Phase 1b: Recommended Phase 2 Dose (RP2D)
时间窗: Up to approximately 24 months
RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available.
Phase 1b: Overall Response Rate (ORR)
时间窗: Up to approximately 24 months
ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR).
次要结局
- Phase 1a: ORR(Up to approximately 24 months)
- Phase 1a and 1b: Duration of Response (DOR)(Up to approximately 24 months)
- Phase 1a and 1b: Disease Control Rate (DCR)(Up to approximately 24 months)
- Phase 1a: Plasma Concentration of BG-C0979(Up to approximately 3 months)
- Phase 1a: Area Under the Concentration-Time Curve (AUC) for BG-C0979(Up to approximately 3 months)
- Phase 1a: Maximum Observed Concentration (Cmax) of BG-C0979(Up to approximately 3 months)
- Phase 1a: Time to Maximum Concentration (Tmax) of BG-C0979(Up to approximately 3 months)
- Phase 1a and 1b: Number of Participants with Anti-Drug Antibodies (ADAs)(Up to approximately 24 months)
- Phase 1b: Number of Participants Experiencing Adverse Events (AEs)(Up to approximately 24 months)
- Phase 1b: Progression-Free Survival(Up to approximately 24 months)
- Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC(Up to approximately 24 months)
- Prostate-Specific Antigen (PSA) Response for Participants with CRPC(Up to approximately 24 months)
- Phase 1b: Plasma Concentration of BG-C0979, Alone and in Combination with Tislelizumab(Up to approximately 3 months)