BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05464030 (M9140 M9140 Bevacizumab Capecitabine in Colorectal Cancer): BVCT ex-ante prediction vs. reported outcome

On 8 May 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 23 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05464030
Acronym
PROCEADE-CRC-01
Drug Name
M9140 M9140 Bevacizumab Capecitabine
Drug MoA
anti-CEACAM5 ADC that delivers a payload inhibiting TOP1
Drug Modality
antibody-drug conjugate (ADC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Colorectal Cancer
Human Patients
200
Sponsor
Merck KGaA
Phase
Phase 1

Prediction of , index 1587

Prospective Prediction
Prediction Index
1587
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient (additive) clinical benefit in OS)
Technical Prediction
FAILURE (statistically maybe significant yet weak (additive) clinical benefit in ORR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
15 days in advance
Readout Data Interpretation
7.5% cORR and 12.9-13.9 months OS and 15% TEAE discontinuation (vs 39% ORR for SoC FOLFOX + bevacizumab) (Source- ASCO abstract 231480).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)
Phase
Phase 1
Status
Active not recruiting
Enrollment
220
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Conditions
Colorectal Cancer
Interventions
DRUG: M9140; DRUG: M9140; DRUG: Bevacizumab; DRUG: Capecitabine; DRUG: 5-fluorouracil (5-FU); DRUG: Folinic acid
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-08-04
Primary completion
2026-10-23
Completion
2026-10-23
Primary outcomes
  • Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) (up to 4 months)
  • Part 1: Recommended Dose Expansion (RDE) of M9140 (up to 4 months)
  • Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) (up to 8 months)
  • Part 2A: Number of Participants with Adverse Events (AEs) (up to 8 months)
  • Part 2A: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators (Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months)

NCT05464030 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials