A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participan… (NCT05379595) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
United States225 participantsStarted 2022-07-29
Plain-language summary
The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts) and to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
* Participant must have tumor previously characterized as having wild-type Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), and without evidence of Erb-b2 receptor tyrosine kinase 2/human epidermal growth factor receptor 2 (ERBB2/HER2) amplification. Additional cohort-specific requirements:
* Phase (Ph) 2 (Cohorts A, B, and C) Amivantamab monotherapy: Participant must have received at least 2 but not more than 3 prior lines of systemic therapy in the metastatic setting. Participant must have been diagnosed with left-sided colorectal cancer (CRC) (Cohort A and B) and right-sided (Cohort C)and have received or been intolerant to standard of care (SoC) fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and an anti-vascular endothelial growth factor (VEGF) treatment. Participant must be anti-EGFR treatment naive in Cohort A, an anti-epidermal growth factor receptor (EGFR) treatment Cohort B, with or without an anti-EGFR treatment in Cohort C
* Ph 1b Dose Confirmation Cohorts (Ph1b-D and Ph1b-E), Ph2 (Cohorts D and E) Amivantamab+mFOLFOX6/FOLFIRI: Participant must been diagnosed with CRC and have received no more than 1 prior line of systemic therapy in the metastatic setting. Cohort P…
What they're measuring
1
Cohorts A, B, and C: Objective Response Rate (ORR)
Timeframe: Up to 4 years 3 months
2
Cohorts Ph1b-D and Ph1b-E: Number of Participants with Dose-limiting Toxicity (DLT)
Timeframe: Up to 4 years 3 months
3
Cohorts Ph1b-D and Ph1b-E: Number of Participants with DLT by Severity
Timeframe: Up to 4 years 3 months
4
Cohorts D and E: Number of Participants with Adverse Events (AE)
Timeframe: Up to 4 years 3 months
5
Cohorts D and E: Number of Participants with Laboratory Values Abnormalities
Timeframe: Up to 4 years 3 months
6
Cohorts D and E: Number of Participants with Vital Signs Abnormalities
Timeframe: Up to 4 years 3 months
7
Cohorts F: Number of Participants with Adverse Events (AE)
Timeframe: Up to 4 years 3 months
8
Cohorts F: Number of Participants with Laboratory Values Abnormalities