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NCT04855656 (lunresertib and camonsertib in Advanced Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 18 Jan 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 12 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant yet weak (in ORR) and commercially insufficient (in ORR).

Clinical Trial

NCTID
NCT04855656
Acronym
MYTHIC
Drug Name
lunresertib (RP-6306) and camonsertib (RP-3500)
Drug MoA
PKMYT1 inhibitor and ATR inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Solid Tumors
Human Patients
364
Sponsor
Repare Therapeutics
Phase
Phase 1

Prediction of , index 851

Prospective Prediction
Prediction Index
851
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
694 days in advance
Readout Data Interpretation
lunresertib + camonsertib achieved 18.5% confirmed ORR (5/27) for endometrial cancer; which is non-superior to pembrolizumab + lenvatinib that achieved 38% ORR (DOI- 10.6004/jadpro.2022.13.1.4); lunresertib + camonsertib achieved 16.7% confirmed ORR (4/24) for platinum-resistant ovarian cancer; which is inferior to chemotherapy + bevacizumab that achieved 27.3% ORR
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant yet weak (in ORR) and commercially insufficient (in ORR)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
Phase
Phase 1
Status
Recruiting
Enrollment
464
Lead sponsor
Debiopharm International SA
Conditions
Advanced Solid Tumor
Interventions
DRUG: Lunresertib; DRUG: RP-3500; DRUG: Debio0123
Design
Non randomized · Single group · None
Primary purpose
Treatment
Start
2021-04-30
Primary completion
2027-12
Completion
2028-06
Primary outcomes
  • Safety and Tolerability of lunresertib either in monotherapy or in combination with RP-3500 or with Debio 0123 in patients with eligible advanced solid tumors (Up to 90 days after last administration of study intervention)
  • To define the MTD of lunresertib monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule (Up to 90 days after last administration of study intervention)
  • To define the MTD of lunresertib in combination with RP-3500 or in combination with Debio 0123, and determine a recommended Phase 2 dose (RP2D) and preferred schedule (Up to 90 days after last administration of study intervention)
  • The relative bioavailability of lunresertib capsule formulation as compared to lunresertib tablet formulation in the fasted state (Time 0 (time of dosing) to 72 hours post-dose for each treatment condition)
  • The effect of food on the PK of tablet formulation of lunresertib when administered in fed conditions compared to administration under fasted conditions (Time 0 (time of dosing) to 72 hours post-dose for each treatment condition)

NCT04855656 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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