BioinvestGPT

BioinvestGPT ApS · Research use only

NCT03504488 (CAB-ROR2-ADC PD-1 inhibitor in TNBC or Head & Neck Cancer…): BVCT ex-ante prediction vs. reported outcome

On 30 Nov 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 14 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet commercially insufficient.

Clinical Trial

NCTID
NCT03504488
Drug Name
CAB-ROR2-ADC PD-1 inhibitor
Drug MoA
anti-ROR2 ADC
Drug Modality
antibody-drug conjugate (ADC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)
Human Patients
420
Sponsor
BioAtla
Phase
Phase 1 Phase 2

Prediction of , index 1239

Prospective Prediction
Prediction Index
1239
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
partial SUCCESS (statistically significant yet weak additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
166 days in advance
Readout Data Interpretation
7% ORR for melanoma (vs 21-36% ORR by anti-PD1 + anti-CLTA4 / TIL cell therapy).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2)
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
132
Lead sponsor
BioAtla, Inc.
Conditions
Non Small Cell Lung Cancer; Triple Negative Breast Cancer; Melanoma; Head and Neck Cancer
Interventions
BIOLOGICAL: CAB-ROR2-ADC; BIOLOGICAL: PD-1 inhibitor
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2018-06-27
Primary completion
2024-12-30
Completion
2024-12-30
Primary outcomes
  • Phase 1: Safety Profile (Up to 24 months)
  • Phase 1: Safety Profile (Up to 24 months)
  • Phase 1 and 2: Safety Profile (Up to 24 months)
  • Phase 2: Confirmed Objective Response Rate (ORR) (Up to 24 months)

NCT03504488 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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