Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
Phase 1
200
about 4 years
18+
6 sites in CA, RI, TX
About this study
Researchers are testing the safety and effectiveness of a new drug called M9140 in people with advanced solid tumors. The trial will last about 4 months for the first part, followed by another 8 months. This is a Phase 1 trial.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take 5-fluorouracil (5-FU)
- 2.Take Bevacizumab
- 3.Take Capecitabine
- +2 more
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
fluorouracil (Antimetabolite; mimics uracil to disrupt DNA/RNA in cancer cells), bevacizumab, capecitabine
oral (Oral Capsule), infusion, oral (Oral Tablet)
Primary: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs), Part 2A: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators, Part 2A: Number of Participants with Adverse Events (AEs), Part 2A: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators, Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
Secondary: Part 2A: Number of Participants with Symptomatic Adverse Events (AEs), Part 2A: Overall Survival, Parts 1 and 2A: Change from Baseline in QTc (ΔQTc) Interval, Parts 1, 2A, 2B, 2C and 2D: Pharmacokinetic (PK) Plasma Concentrations of M9140, Parts 1, 2A, 2B, 2C and 2D: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators, Parts 1, 2B, 2C and 2D: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator, Parts 1, 2B, 2C: and 2D: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators
Oncology