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NCT03686124 (IMA203 in Recurrent and/​or Refractory Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 29 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 31 May 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (ORR/PFS) and commercially maybe sufficient (slightly superior OS).

Clinical Trial

NCTID
NCT03686124
Acronym
ACTengine
Drug Name
IMA203
Drug MoA
autologous anti-PRAME TCR-T cell therapy
Drug Modality
cell therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Recurrent and/​or Refractory Solid Tumors
Human Patients
476
Sponsor
Immatics
Phase
Phase 1

Prediction of , index 820

Prospective Prediction
Prediction Index
820
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet weak (additive) clinical benefit in OS)
Technical Prediction
SUCCESS (statistically significant (additive) clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
306 days in advance
Readout Data Interpretation
IMA203 achieved 56% cORR and 6.1 months mPFS that are moderately superior to SoC chemotherapy’s 3.7 months mPFS and 10% ORR; IMA203 achieved 15.9 months mOS that’s slightly superior to SoC chemotherapy’s 14 months mOS (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (ORR/PFS) and commercially maybe sufficient (slightly superior OS)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
Phase 1/2 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
375
Lead sponsor
Immatics US, Inc.
Conditions
Refractory Cancer; Recurrent Cancer; Solid Tumor, Adult; Cancer
Interventions
BIOLOGICAL: IMA203 Product; BIOLOGICAL: IMA203 product- flat dose; BIOLOGICAL: IMA203CD8 Product; DRUG: Nivolumab; DEVICE: IMADetect®
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2019-05-14
Primary completion
2028-12
Completion
2032-06
Primary outcomes
  • Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 (28 days)
  • Phase 1 and Phase 2: Number and grade of treatment emergent adverse events and adverse events of special interest in subjects treated. (35 days)
  • Phase 1 and Phase 2: Tumor Response (5 years)

NCT03686124 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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