A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

Официальное название

A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies

Обзор

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.

Вмешательства

• Препарат JNJ-89402638
  JNJ-89402638 will be administered.
• Препарат Bevacizumab
  Bevacizumab or biosimilar will be administered.
• Препарат FOLFOX
  Chemotherapy agent FOLFOX will be administered.
• Препарат FOLFIRI
  Chemotherapy agent FOLFIRI will be administered.

Первичные конечные точки

• Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: From Baseline up to approximately 24 months]
• Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [Срок оценки: From Baseline up to 28 days]

Вторичные конечные точки (10)

• Part 1 and Part 2: Serum Concentration for JNJ-89402638 [Срок оценки: Up to approximately 24 months]
• Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638 [Срок оценки: Up to approximately 24 months]
• Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638 [Срок оценки: Up to approximately 24 months]
• Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638 [Срок оценки: Up to approximately 24 months]
• Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638 [Срок оценки: Up to approximately 24 months]
• Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies [Срок оценки: Up to approximately 24 months]
• Part 1 and Part 2: Overall Response (OR) [Срок оценки: Up to approximately 24 months]
• Part 1 and Part 2: Complete Response (CR) [Срок оценки: Up to approximately 24 months]
• Part 1 and Part 2: Time to Response (TTR) [Срок оценки: Up to approximately 24 months]
• Part 1 and Part 2: Duration of Response (DOR) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• University of Colorado Denver Anschultz Medical Campus — Aurora
• Florida Cancer Specialists — Sarasota
• Community Health Network — Indianapolis
• Start Midwest — Grand Rapids
• Swedish Cancer Institute — Seattle

Испания · 4 центра

• Hosp Univ Vall D Hebron — Barcelona
• Hosp Univ Fund Jimenez Diaz — Madrid
• Hosp. Univ. 12 de Octubre — Madrid
• Hosp Univ Hm Sanchinarro — Madrid

South Korea · 2 центра

• Severance Hospital Yonsei University Health System — Seoul
• Asan Medical Center — Seoul

Идентификаторы

NCT: NCT06663319 · 89402638GIC1001 · 2024-516526-66-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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