Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
← catalyst calendarNCT04429542 · readout in 134 d
Sponsored by Bicara Therapeutics (industry) · BCAX — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
292estimated
Sites
20
Countries
Australia, Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-06-01 | actual | When the study began enrolling |
| Primary completion | 2026-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-01 | estimated | The whole study's end, after follow-up |
| First posted | 2020-06-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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 — also filed as Ficerafusp alfa
- Drug: Pembrolizumab
Primary outcomes
what the primary-completion date above is the date OFSafety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
measured 24 months
Tolerability of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
measured 24 months
Incidence of Dose Limiting Toxicities (DLTs)
measured 21 days
Publications
- PMID 42102329 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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