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NCT05497453 (OTX-2002 in advanced solid tumor): BVCT ex-ante prediction vs. reported outcome

On 27 Feb 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 14 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably significant and commercially insufficient (weak efficacy).

Clinical Trial

NCTID
NCT05497453
Acronym
MYCHELANGELO I
Drug Name
OTX-2002
Drug MoA
LNP-encapsulated mRNAs of ZF-DNMT and ZF-KRAB proteins
Drug Modality
mRNA medicine
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced solid tumor
Human Patients
190
Sponsor
Omega Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1103

Prospective Prediction
Prediction Index
1103
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit due to the inferior-to-atezolizumab+bevacizumab efficacy of OTX2002 combotherapies)
Technical Prediction
partial SUCCESS (statistically significant yet weak clinical benefit for OTX2002 monotherapy and OTX2002 combotherapies)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
261 days in advance
Readout Data Interpretation
OTX2002 achieved 50% DCR for HCC in line with historical benchmark range for approved TKIs and PD1 monotherapies (29-65%) and its further development is discontinued
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably significant and commercially insufficient (weak efficacy)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of OTX-2002 As a Single Agent and in Combination with Standard of Care in Patients with Hepatocellular Carcinoma and Other Solid Tumor Types Known for Association with the MYC Oncogene
Phase
Phase 1, Phase 2
Status
Terminated
Enrollment
24
Lead sponsor
Omega Therapeutics
Conditions
Hepatocellular Carcinoma; Solid Tumor; Hepatocellular Carcinoma Non-resectable; Hepatocellular Carcinoma Recurrent; Hepatocellular Cancer; Liver Cancer; Liver, Cancer Of, Non-Resectable
Interventions
DRUG: OTX-2002; DRUG: Tyrosine kinase inhibitor One; DRUG: Tyrosine kinase inhibitor Two; DRUG: Checkpoint Inhibitor, Immune
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2022-08-19
Primary completion
2024-11-21
Completion
2024-11-21
Primary outcomes
  • Determine Dose limiting toxicities (DLT)and maximum tolerated dose ( MTD) (Part 1 escalation and Part 2 safety run-in) (28 days/4 weeks from the first dose of OTX-2002)
  • Incidence of TEAEs including all AEs,Grade 3-5 AEs, drug-related AEs, and SAEs (Part 1 escalation and Part 2 safety run-in) (30 days after the last dose of study drug)
  • Overall response rate (ORR)(for Part 1 and Part 2 expansion) (through treatment completion, up to two years)
  • Duration of Response (DOR) (for Part 1 and Part 2 expansion) (through treatment completion, up to two years)

NCT05497453 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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