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NCT05238922 (INCB0123667 in Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 9 Sep 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 14 Sep 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant (yet weak efficacy) and commercially TBD.

Clinical Trial

NCTID
NCT05238922
Drug Name
INCB0123667
Drug MoA
CDK2 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Solid Tumors
Human Patients
340
Sponsor
Incyte Corporation
Phase
Phase 1

Prediction of , index 1778

Prospective Prediction
Prediction Index
1778
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in ORR/PFS with moderate toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
5 days in advance
Readout Data Interpretation
INCB123667 achieved 24.3% ORR (<25% is generally accepted as weak efficacy) without positive dose-response relationship.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant (yet weak efficacy) and commercially TBD
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors
Phase
Phase 1
Status
Active not recruiting
Enrollment
291
Lead sponsor
Incyte Corporation
Conditions
Solid Tumors
Interventions
DRUG: INCB0123667; DRUG: Palbociclib; DRUG: Bevacizumab; DRUG: Olaparib; DRUG: Paclitaxel; DRUG: Ribociclib; DRUG: Fulvestrant
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-07-05
Primary completion
2027-07-27
Completion
2027-08-31
Primary outcomes
  • Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) (Up to Day 28)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Up to 12 months)
  • Number of Participants with Dose Interruptions due to TEAE (Up to 12 months)
  • Number of Participants who Undergo Dose Reductions due to TEAE (Up to 12 months)
  • Number of Participants Discontinue study due to TEAE (Up to 12 months)

NCT05238922 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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