RecruitingPhase 1

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

United States292 participantsStarted 2020-06-01

Plain-language summary

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Single agent BCA101 - patients with the following tumor type will be eligible:
✓. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:
✓. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab • Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.

What they're measuring

Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs

Timeframe: 24 months

Tolerability of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs

Timeframe: 24 months

Incidence of Dose Limiting Toxicities (DLTs)

Timeframe: 21 days

Trial details

NCT IDNCT04429542

SponsorBicara Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

David Bohr

6178000335 info@bicara.com

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