A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
Janssen Research & Development, LLC
Summary
The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) of 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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 histological…
Interventions
- DrugJNJ-89402638
JNJ-89402638 will be administered.
- DrugBevacizumab
Bevacizumab or biosimilar will be administered.
- DrugFOLFOX
Chemotherapy agent FOLFOX will be administered.
- DrugFOLFIRI
Chemotherapy agent FOLFIRI will be administered.
Locations (11)
- University of Colorado Denver Anschultz Medical CampusAurora, Colorado
- Florida Cancer SpecialistsSarasota, Florida
- Community Health NetworkIndianapolis, Indiana
- Start MidwestGrand Rapids, Michigan
- Swedish Cancer InstituteSeattle, Washington
- Severance Hospital Yonsei University Health SystemSeoul