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NCT03881488 (CTX-471 pembrolizumab in Metastatic or Locally Advanced Malignancies): BVCT ex-ante prediction vs. reported outcome

On 26 Jul 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 23 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD.

Clinical Trial

NCTID
NCT03881488
Drug Name
CTX-471 pembrolizumab
Drug MoA
CD137 agonist
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic or Locally Advanced Malignancies
Human Patients
157
Sponsor
Compass Therapeutics
Phase
Phase 1

Prediction of , index 1196

Prospective Prediction
Prediction Index
1196
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit yet maybe non-superior to SoC)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
302 days in advance
Readout Data Interpretation
26% ORR vs 22-23% ORR for SoC (ARX517); OS data pending.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-471 Administered Either as a Monotherapy or in Combination With Pembrolizumab in Patients With Inadequate Responses to PD-1/PD-L1 Checkpoint Inhibitors in Metastatic or Locally Advanced Malignancies
Phase
Phase 1
Status
Completed
Enrollment
100
Lead sponsor
Compass Therapeutics
Conditions
Locally Advanced Solid Tumor; Metastatic Cancer; Non-small Cell Lung Cancer; Small Cell Lung Cancer; Mesothelioma; Melanoma; Head and Neck Cancer
Interventions
DRUG: CTX-471; DRUG: Pembrolizumab (KEYTRUDA®)
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2019-05-17
Primary completion
2025-05-21
Completion
2025-05-21
Primary outcomes
  • Number of participants with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities (From first dose of CTX-471 (Week 1 Day 1) until 60 days after the last CTX-471 injection (up to 2 years))

NCT03881488 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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