A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 19
- 主要终点
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
研究概览
简要总结
The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.
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
- •For Part 1 (dose escalation), Part 2 (Arm A [JNJ-89402638 monotherapy]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting
- •Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
- •Part 1: Must have either measurable or evaluable disease
- •Part 2: Must have at least 1 measurable lesion
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula
排除标准
- •Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
- •Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (<=)1 (except alopecia, vitiligo, Grade <= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary
- •Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
- •Received glucocorticoids (doses >10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
- •Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment
研究组 & 干预措施
Part 2 (Dose Expansion): Arm C
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX.
干预措施: FOLFOX (Drug)
Part 2 (Dose Expansion): Arm D
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI.
干预措施: FOLFIRI (Drug)
Part 2 (Dose Expansion): Arm E
Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1.
干预措施: JNJ-89402638 (Drug)
Part 2 (Dose Expansion): Arm D
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI.
干预措施: Bevacizumab (Drug)
Part 2 (Dose Expansion): Arm C
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX.
干预措施: JNJ-89402638 (Drug)
Part 2 (Dose Expansion): Arm C
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX.
干预措施: Bevacizumab (Drug)
Part 2 (Dose Expansion): Arm D
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI.
干预措施: JNJ-89402638 (Drug)
Part 2 (Dose Expansion): Arm B
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar.
干预措施: Bevacizumab (Drug)
Part 1 (Dose Expansion)
Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) and optimal route(s) of administration for JNJ-89402638 monotherapy have been identified.
干预措施: JNJ-89402638 (Drug)
Part 2 (Dose Expansion): Arm A
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1 as a monotherapy.
干预措施: JNJ-89402638 (Drug)
Part 2 (Dose Expansion): Arm B
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar.
干预措施: JNJ-89402638 (Drug)
结局指标
主要结局
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
时间窗: From Baseline up to approximately 24 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus.
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
时间窗: From Baseline up to 28 days
The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.
次要结局
- Part 1 and Part 2: Serum Concentration for JNJ-89402638(Up to approximately 24 months)
- Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638(Up to approximately 24 months)
- Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638(Up to approximately 24 months)
- Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638(Up to approximately 24 months)
- Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638(Up to approximately 24 months)
- Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies(Up to approximately 24 months)
- Part 1 and Part 2: Overall Response (OR)(Up to approximately 24 months)
- Part 1 and Part 2: Complete Response (CR)(Up to approximately 24 months)
- Part 1 and Part 2: Time to Response (TTR)(Up to approximately 24 months)
- Part 1 and Part 2: Duration of Response (DOR)(Up to approximately 24 months)