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NCT05506943 (Tovecimig in advanced billiard tract cancers): BVCT ex-ante prediction vs. reported outcome

On 3 Nov 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 27 Apr 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (ORR/PFS) and commercially insufficient (non-superior OS).

Clinical Trial

NCTID
NCT05506943
Acronym
COMPANION-002
Drug Name
Tovecimig (CTX009)
Drug MoA
bispecific antibody that inhibits both DLL4 and VEGF-A
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced billiard tract cancers
Human Patients
168
Sponsor
Compass Therapeutics
Phase
Phase 2 Phase 3

Prediction of , index 1195

Prospective Prediction
Prediction Index
1195
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient additive clinical benefit in OS superior to paclitaxel monotherapy for high-DLL4-baseline-expression patients) partial FAILURE (commercially insufficient additive clinical benefit in OS non-superior to paclitaxel monotherapy for low-DLL4-baseline-expression patients)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in ORR/PFS superior to paclitaxel monotherapy regardless of DLL4 baseline expression)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
540 days in advance
Readout Data Interpretation
tovecimig + paclitaxel achieved 17.1% ORR superior to 5.3% ORR for paclitaxel alone (p=0.031), achieved 4.7 months mPFS moderately superior to 2.6 months achieved by paclitaxel alone (HR = 0.44, p<0.0001) and achieved 8.9 months mOS non-superior to 9.4 months achieved by paclitaxel alone despite crossover (HR = 1.05, p=0.78)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (ORR/PFS) and commercially insufficient (non-superior OS)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen
Phase
Phase 2, Phase 3
Status
Active not recruiting
Enrollment
168
Lead sponsor
Compass Therapeutics
Conditions
Biliary Tract Cancer; Cholangiocarcinoma; Gall Bladder Cancer; Ampullary Cancer
Interventions
DRUG: CTX-009; DRUG: Paclitaxel
Design
Randomized · Parallel · Single
Primary purpose
Treatment
Start
2023-01-09
Primary completion
2027-08-31
Completion
2027-08-31
Primary outcomes
  • Best Overall Response (From randomization to treatment discontinuation for any reason, average 6 months)

NCT05506943 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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