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NCT05548296 (ACR-368 Gemcitabine OncoSignature in Ovarian Carcinoma; Endometrial Adenocarcinoma; and Urothelial…): BVCT ex-ante prediction vs. reported outcome

On 3 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 24 Apr 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05548296
Drug Name
ACR-368 Gemcitabine OncoSignature
Drug MoA
CHEK1/CHEK2 small molecule inhibitor with OncoSignature predictive biomarkers
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Ovarian Carcinoma; Endometrial Adenocarcinoma; and Urothelial Carcinoma
Human Patients
390
Sponsor
Acrivon Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1493

Prospective Prediction
Prediction Index
1493
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in the OncoSignature positive monotherapy arm with superior efficacy over the OncoSignature negative combotherapy arm)
Technical Prediction
SUCCESS (statistically significant clinical benefit in the OncoSignature positive arm)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
52 days in advance
Readout Data Interpretation
50% ORR for oncosignature positive arm vs 0% Orr for oncosignature negative arm (p=0.0038) vs 42.3% ORR of mirvetuximab soravtansine for patients selected by FOLRalpha; anti-correlation between dosage and efficacy.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer
Phase
Phase 2
Status
Recruiting
Enrollment
350
Lead sponsor
Acrivon Therapeutics
Conditions
Endometrial Adenocarcinoma
Interventions
DRUG: ACR-368; DRUG: Gemcitabine; DIAGNOSTIC_TEST: OncoSignature
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2022-08-29
Primary completion
2027-05-30
Completion
2027-11-30
Primary outcomes
  • Arm 1: Anti-tumor activity of ACR-368 in Endometrial cancer subjects that are OncoSignature Positive. (Response will be assessed every 8 weeks from baseline through 2 years or death.)
  • Arm 2: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects that are OncoSignature Negative. (Response will be assessed every 8 weeks from baseline through 2 years or death.)
  • Arm 3: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers). (Response will be assessed every 8 weeks from baseline through 2 years or death.)
  • Arm 4: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers). (Response will be assessed every 8 weeks from baseline through 2 years or death.)

NCT05548296 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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