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NCT03715933 (INBRX-109 in 3L+ mCRC): BVCT ex-ante prediction vs. reported outcome

On 21 Feb 2026, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 21 Apr 2026 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant (overall slightly superior ORR/PFS) and commercially TBD.

Clinical Trial

NCTID
NCT03715933
Drug Name
INBRX-109
Drug MoA
tetravalent DR5 agonist antibody Ozekibart
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
3L+ mCRC
Human Patients
411
Sponsor
Inhibrx
Phase
Phase 1

Prediction of , index 1310

Prospective Prediction
Prediction Index
1310
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS moderately superior to FTD-TPI + bevacizumab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS slightly superior to FTD-TPI + bevacizumab)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
59 days in advance
Readout Data Interpretation
Ozekibart (INBRX-109) + FOLFIRI achieved 20% cORR and 5.5 months mPFS, which is slightly superior to 6.1% cORR and 5.6 months mPFS achieved by the SoC FTD–TPI plus bevacizumab for 3L+ mCRC (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant (overall slightly superior ORR/PFS) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Phase
Phase 1
Status
Recruiting
Enrollment
411
Lead sponsor
Inhibrx Biosciences, Inc
Conditions
Ewing Sarcoma; Colorectal Adenocarcinoma
Interventions
DRUG: INBRX-109; DRUG: Irinotecan; DRUG: Temozolomide; DRUG: carboplatin; DRUG: pemetrexed; DRUG: Leucovorin; DRUG: Fluorouracil; DRUG: Bevacizumab; DRUG: Trifluridine + Tipiracil
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2018-10-08
Primary completion
2028-12
Completion
2029-06
Primary outcomes
  • Frequency and severity of adverse events of INBRX-109 (Up to 8 years)
  • Evaluating Tumor Response for colorectal cancers and Ewing sarcoma (Up to 8 years)

NCT03715933 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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