BioinvestGPT ApS · Research use only

NCT05029882 (ABBV-400 in Advanced Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 24 Feb 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 1 May 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet commercially insufficient.

Clinical Trial

Drug Name
ABBV-400
Drug MoA
targets cMET with TOP1i payload
Drug Modality
antibody-drug conjugate (ADC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Solid Tumors
Human Patients
520
Sponsor
AbbVie
Phase
Phase 1

Prediction of , index 1942

Prospective Prediction
Prediction Index
1942
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS as a monotherapy non-superior to SoC for non-CRC advanced solid tumors without further cMET-expression-based stratification) FAILURE (commercially insufficient additive clinical benefit to bevacizumab in OS as a combotherapy inferior to TAS102+bevacizumab for CRC without further cMET-expression-based stratification)
Technical Prediction
partial SUCCESS (statistically significant yet moderate (additive) clinical benefit in ORR/PFS compared with placebo without further cMET-expression-based stratification)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
431 days in advance
Readout Data Interpretation
ABBV-400 achieved 4.6 months PFS and 10.4 months mOS for 3L+ mCRC patients, which are inferior to 5.6 months PFS and 10.8 months mOS achieved by the SoC Trifluridine/tipiracil (TAS102) + bevacizumab (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 as Monotherapy and in Combination With Bevacizumab in Adult Subjects With Advanced Solid Tumors
Phase
Phase 1
Status
Active not recruiting
Enrollment
520
Lead sponsor
AbbVie
Conditions
Non-Small Cell Lung Cancer; Advanced Solid Tumors; Gastroesophageal Adenocarcinoma; Colorectal Cancer
Interventions
DRUG: ABBV-400; DRUG: Trifluridine/Tipiracil; DRUG: Bevacizumab
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2021-10-13
Primary completion
2027-11
Completion
2027-11
Primary outcomes
  • Objective Response Rate (ORR) (Up to 48 Months)

NCT05029882 on ClinicalTrials.gov

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