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NCT04429542 (Ficerafusp Alfa in EGFR-driven Advanced Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 26 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 22 May 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (ORR/PFS) and commercially insufficient (inferior-to-petosemtamab OS).

Clinical Trial

NCTID
NCT04429542
Drug Name
Ficerafusp Alfa (BCA101)
Drug MoA
bispecific antibody with anti-EGFR and anti-TGFbeta targets
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
EGFR-driven Advanced Solid Tumors
Human Patients
292
Sponsor
Bicara Therapeutics
Phase
Phase 1

Prediction of , index 1773

Prospective Prediction
Prediction Index
1773
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient (additive) clinical benefit in OS inferior to chemotherapy/cetuximab/petosemtamab as monotherapy or in combination with pembrolizumab)
Technical Prediction
partial SUCCESS (statistically significant (additive) clinical benefit in ORR/PFS numerically superior to cetuximab yet inferior to petosemtamab as monotherapy or in combination with pembrolizumab)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
269 days in advance
Readout Data Interpretation
ficerafusp alfa + pembrolizumab achieved 54% ORR; 7.4 months mPFS; and 61.5% 12-month OS (see DOI- 10.1200/JCO.2025.43.16_suppl.601); inferior to petosemtamab + pembrolizumab’s 63% ORR; 9 months mPFS; and 79% 12-month OS (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (ORR/PFS) and commercially insufficient (inferior-to-petosemtamab OS)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors
Phase
Phase 1
Status
Recruiting
Enrollment
292
Lead sponsor
Bicara Therapeutics
Conditions
Head and Neck Squamous Cell Carcinoma; Squamous Cell Carcinoma of Anal Canal; Colorectal Cancer; Squamous Cell Carcinoma of the Lung; EGFR Amplification; Epithelial Ovarian Cancer; Pancreas Cancer; Cutaneous Squamous Cell Carcinoma; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Interventions
DRUG: BCA101; DRUG: Pembrolizumab
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2020-06-01
Primary completion
2026-12-31
Completion
2027-06-01
Primary outcomes
  • Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs (24 months)
  • Tolerability of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs (24 months)
  • Incidence of Dose Limiting Toxicities (DLTs) (21 days)

NCT04429542 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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