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NCT04660929 (CT-0508 Pembrolizumab in HER2-positive Adenocarcinoma Bile Duct Cancer Biliary…): BVCT ex-ante prediction vs. reported outcome

On 31 Oct 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 1 Apr 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
NCT04660929
Drug Name
CT-0508 Pembrolizumab
Drug MoA
anti-HER2 CAR-M1
Drug Modality
CAR-Macrophage therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
HER2-positive Adenocarcinoma Bile Duct Cancer Biliary Tract Cancer Bladder Cancer Breast Cancer Breast Neoplasm Carcinoma Ductal Carcinoma Hepatocellular Cancer Lung Cancer Non-Small Cell Carcinoma Ovarian Epithelial Carcinoma Small Cell Carcinoma Squamous Carcinoma Transitional Cell Colorectal Cancer Esophagogastric Junction Neoplasms Inflammatory Breast Cancer Stomach Neoplasms Malignant Neoplasms Ovarian Neoplasms Pancreatic Cancer HER2- positive Solid Tumors HER2-positive Breast Cancer HER2-positive Gastric Cancer HER-2 Protein Overexpression HER-2 Gene Amplification Prostate Cancer Head and Neck Cancer Endometrial Cancer Lung Cancer Small Cel
Human Patients
48
Sponsor
Carisma Therapeutics
Phase
Phase 1

Prediction of , index 1307

Prospective Prediction
Prediction Index
1307
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
153 days in advance
Readout Data Interpretation
safe yet terminated due to insufficient efficacy.
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 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects With HER2 Overexpressing Solid Tumors
Phase
Phase 1
Status
Unknown
Enrollment
48
Lead sponsor
Carisma Therapeutics Inc
Conditions
HER2-positive; Adenocarcinoma; Bile Duct Cancer; Biliary Tract Cancer; Bladder Cancer; Breast Cancer; Breast Neoplasm; Carcinoma, Ductal; Carcinoma, Hepatocellular; Cancer; Lung Cancer, Non-Small-Cell; Carcinoma, Ovarian Epithelial; Carcinoma, Small Cell; Carcinoma, Squamous; Carcinoma, Transitional Cell; Colorectal Cancer; Esophagogastric Junction Neoplasms; Inflammatory Breast Cancer; Stomach Neoplasms; Malignant Neoplasms; Ovarian Neoplasms; Pancreatic Cancer; HER2-positive Solid Tumors; HER2-positive Breast Cancer; HER2-positive Gastric Cancer; HER-2 Protein Overexpression; HER-2 Gene Amplification; Prostate Cancer; Head and Neck Cancer; Endometrial Cancer; Lung Cancer, Small Cell
Interventions
BIOLOGICAL: CT-0508; BIOLOGICAL: Pembrolizumab
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2021-02-02
Primary completion
2024-12-31
Completion
2024-12-31
Primary outcomes
  • Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors. (14 months)
  • Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria. (12 months)
  • Assess the safety and tolerability of CT-0508 in combination with pembrolizumab by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors (CT-0508 and pembrolizumab substudy only) (14 months)

NCT04660929 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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