Colorectal Neoplasms, Gastrointestinal Neoplasms
Conditions
Brief summary
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.
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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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 1. Part 1: Must have either measurable or evaluable disease 2. 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity | 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) | From Baseline up to 28 days | The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 and Part 2: Serum Concentration for JNJ-89402638 | Up to approximately 24 months | Serum Concentration for JNJ-89402638 will be reported. |
| Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638 | Up to approximately 24 months | Cmax of JNJ-89402638 will be reported. |
| Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638 | Up to approximately 24 months | Cmin of JNJ-89402638 will be reported. |
| Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638 | Up to approximately 24 months | Tmax of JNJ-89402638 will be reported. |
| Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638 | Up to approximately 24 months | AUC of JNJ-89402638 will be reported. |
| Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies | Up to approximately 24 months | Participants with anti-JNJ-89402638 antibodies will be reported. |
| Part 1 and Part 2: Overall Response (OR) | Up to approximately 24 months | Overall response is best response of complete response (CR) or partial response (PR), assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1. |
| Part 1 and Part 2: Complete Response (CR) | Up to approximately 24 months | Complete response is defined as a best response of CR assessed according to RECIST version 1.1. |
| Part 1 and Part 2: Time to Response (TTR) | Up to approximately 24 months | TTR is defined for participants who achieved an OR from the time of the first dose of study treatment to the first response of PR or better as assessed according to RECIST version 1.1. |
| Part 1 and Part 2: Duration of Response (DOR) | Up to approximately 24 months | DOR is defined for participants who achieved an OR in the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death due to any cause, whichever occurs first, as assessed according to RECIST version 1.1 |
Countries
South Korea, Spain, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed