A Phase 1a/b, First-in-Human Dose Escalation and Dose Expansion Clinical Study of the Dual Targeting Trop-2 and Nectin-4 Multibody Drug Conjugate BD200 in Participants With Select Unresectable Locally Advanced or Metastatic Cancers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Phase 1 Part A
研究概览
简要总结
The Phase 1 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of BD200 in adult participants with advanced solid cancers. This is an open-label study consisting of two-parts: Part A Dose Escalation and Part B Dose Expansion. At least one tumor-specific cohort will be selected in Part B 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
- •Age 18+ years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Participant willing to provide tumor biopsies
- •Measurable disease per RECIST v1.1
- •Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options
- •Satisfy requirements for prior treatments per tumor type as outlined in the protocol
- •Adequate organ function
- •Agree to contraception requirements as outlined in the protocol
排除标准
- •Any major surgery or traumatic injury prior to enrollment
- •Unhealed wounds from surgery or injury
- •Received other therapies within 4 weeks prior to enrollment
- •Any clinically significant chronic gastrointestinal (GI) disorder
- •Any clinically significant ascites or liver disease
- •Any clinically significant pulmonary compromise
- •Active infection at the time enrollment
- •Active autoimmune disease
- •History or active skin disease requiring frequent treatment
- •Any clinically significant corneal disorder
- •Active known second malignancy
- •Any clinically significant cardiac disease
- •Participants with tumor abutting or eroding a major vessel
- •Pregnant or lactating or planning to become pregnant
- •Known hypersensitivity to BD200 or any of its ingredients
- •Unresolved toxicities from previous anticancer therapy
- •Participation in a concurrent clinical study in the treatment period
- •Part A Only: Participant with hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV) infection
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Part A Dose Escalation
Participants with advanced or metastatic solid tumors will receive BD200.
干预措施: BD200 (Drug)
Part B Dose Expansion
Participants with at least one tumor type will receive BD200.
干预措施: BD200 (Drug)
结局指标
主要结局
Phase 1 Part A
时间窗: Cycle 1 Day 1 through Cycle 1 Day 21 [approximately 21 days]
Number of Participants with Dose Limiting Toxicities (DLTs)
Phase 1 Part A & Part B
时间窗: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [approximately 12 months]
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Phase 1 Part A & Part B
时间窗: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator
Phase 1 Part A & Part B
时间窗: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]
Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator
次要结局
- Phase 1 Part A & Part B(Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]))
- Phase 1 Part A & Part B(Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
- Phase 1 Part A(Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
- Phase 1 Part A(Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]))
- Phase 1 Part B(Cycle 1 Day 1 through EOT [up to approximately 12 months])
- Phase 1 Part B(Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]))