NCT07195916招募中1 期
A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 30
- 主要终点
- Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
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.
- •ECOG performance status of 0 or
- •Histologically confirmed:
- •Clear cell renal cell carcinoma (ccRCC).
- •Diffuse large B-cell lymphoma (DLBCL, NOS).
- •High-grade B-cell lymphoma (HGBCL).
- •Peripheral T-cell lymphoma (PTCL, incl. NOS and ALCL).
- •Cutaneous T-cell lymphoma (CTCL, incl. MF or SS ≥Stage IIB with B0/B1 blood involvement).
- •Disease progression, relapse, or refractory to prior therapy:
- •ccRCC: ≥1 prior line incl. ICI + TKI.
- •DLBCL/HGBCL: ≥2 prior lines incl. immunochemotherapy and salvage.
- •PTCL/CTCL: ≥1 prior systemic therapy.
- •Measurable disease by RECIST v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL/USCLC/EORTC (CTCL).
- •Tumor tissue available for central testing.
排除标准
- •Untreated or progressive CNS disease unless previously treated and stable.
- •Other active invasive malignancy within 2 years (except certain low-risk cancers).
- •Prior CD70-targeting therapy, including CAR T.
- •ASCT or CAR T ≤12 weeks before enrollment; prior organ or allogeneic transplant.
- •Unresolved ≥Grade 2 toxicity from prior therapy (with exceptions).
- •Primary immunodeficiency or active autoimmune disease requiring immunosuppression.
- •Active HBV, HCV, HIV, or other chronic infections requiring systemic therapy.
- •Pregnancy, breastfeeding, or unwillingness to use effective contraception.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Part 1a Dose Escalation
Experimental
INCA036873 will be administered at the protocol defined dose.
干预措施: INCA036873 (Drug)
Part 1b Dose Expansion
Experimental
INCA036873 will be administered at the protocol defined dose.
干预措施: INCA036873 (Drug)
Part 1c Pharmacodynamic Cohort
Experimental
INCA036873 will be administered at the protocol defined dose.
干预措施: INCA036873 (Drug)
结局指标
主要结局
Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)
时间窗: Up to Day 28
Toxicities occurring during the first study drug infusion and continues through 28 days as defined in the protocol. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to approximately 2 years and 90 days
TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
次要结局
- Objective response(Up to approximately 2 years)
- Pharmacokinetics Parameter: Cmax of INCA036873(Up to approximately 2 years and 90 days)
- Pharmacokinetics Parameter: Tmax of INCA036873(Up to approximately 2 years and 90 days)
- Pharmacokinetics Parameter: Cmin of INCA036873(Up to approximately 2 years and 90 days)
- Pharmacokinetics Parameter: AUC(0-t) of INCA036873(Up to approximately 2 years and 90 days)
- Pharmacokinetics Parameter: AUC 0-∞ of INCA036873(Up to approximately 2 years and 90 days)
- Pharmacokinetics Parameter: CL of INCA036873(Up to approximately 2 years and 90 days)
- Pharmacokinetics Parameter: Vz of INCA036873(Up to approximately 2 years and 90 days)
- Pharmacokinetics Parameter: t1/2 of INCA036873(Up to approximately 2 years and 90 days)
- Disease control(Up to approximately 2 years)
- Duration of Response (DOR)(Up to approximately 2 years)
研究者
研究点 (30)
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