Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
Phase 1
200
about 4 years
18+
6 sites in CA, RI, TX
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take 5-fluorouracil (5-FU)
- 2.Take Bevacizumab
- 3.Take Capecitabine
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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