A Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 6
- 主要终点
- Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of KIVU-107, a PTK7-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.
详细描述
Part A: The primary objective of Part A of this study is to evaluate the safety and tolerability of KIVU-107 and to determine the maximum tolerated dose (MTD)/Recommended Dose for Expansion (RDE).
Part B: The primary objective of Part B of this study is to confirm the safety and tolerability of KIVU-107 at the RDE.
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
- •Male or female ≥18 years of age
- •No therapy of proven efficacy exists for the tumor
- •Pathologically or histologically documented diagnosis of advanced / metastatic solid tumor malignancy that is resistant to standard therapy or for which no standard therapy is available.
- •Adequate bone marrow, kidney, and liver function
- •Measurable disease using RECIST v1.1
- •ECOG 0 or 1
- •Life expectancy ≥ 3 months
排除标准
- •Prior treatment with any ADC with topoisomerase 1 inhibitor payload
- •Any PTK7 - targeted therapy
- •Uncontrolled cardiovascular disease
- •Active Hepatitis B, Hepatitis C, or HIV infection
- •History of interstitial lung disease
- •Major surgery, radiation therapy, or systemic anti-cancer within 3 weeks of study treatment start.
研究组 & 干预措施
Dose Finding
Part A: KIVU-107 Dose Finding - Participants will be treated with KIVU-107 in multiple ascending cohorts.
干预措施: KIVU-107 (Drug)
Dose Expansion
Part B: KIVU-107 Dose Expansion - Participants will be treated with the RDE from Part A.
干预措施: KIVU-107 (Drug)
结局指标
主要结局
Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)
时间窗: Up to 18 months
Number of participants with treatment emergent adverse events
Number of participants with treatment related adverse events as assessed by CTCAE version 5.0
时间窗: Up to 18 months
To evaluate safety and tolerability of KIVU-107
时间窗: Up to 30 months
Number of participants with treatment related adverse events as assessed by CTCAE v5.0
次要结局
- Objective Response Rate (ORR) is percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1(Up to 30 months)
- Duration of Response (DOR)(Up to 30 months)
- To evaluate the immunogenicity as measured by change of anti-drug antibodies in participants treated with KIVU-107(Up to 30 months)
- Maximum Serum concentration of KIVU-107 (Cmax)(21 days)
- Maximum serum concentration of KIVU-107 (Cmin)(21 days)
- Maximum Serum concentration of KIVU-107 at Steady State (Cmax, ss)(up to 168 days)
- Minimum Serum Concentration of KIVU-107 at Steady State (Cmin, ss)(up to 168 days)
- Time of Maximum Serum Concentration of KIVU-107 (Tmax)(up to 168 days)
- Time of Minimum Serum Concentration of KIVU-107 (Tmin)(up to 168 days)
- Time of Minimum Serum Concentration of KIVU-107 (Tmin, ss)(Up to 168 days)
- Terminal Half-Life (t1/2) of Serum KIVU-107(Up to 168 days)
- Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for KIVU-107(21 days)
- Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for KIVU-107(Up to 168 days)
- Clearance (CL) of KIVU-107(Up to 168 days)
- Apparent volume of distribution during the terminal phase (Vz) of KIVU-107(Up to 168 days)
- Accumulation ration (Rac) of KIVU-107(Up to 168 days)