Recruiting PHASE1 INTERVENTIONAL 2-arm NCT04429542

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

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

Sponsor: Bicara Therapeutics

Conditions Carcinoma, Squamous Cell Colorectal Cancer Cutaneous Squamous Cell Carcinoma EGFR Amplification Epithelial Ovarian Cancer Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Pancreas Cancer Squamous Cell Carcinoma of Anal Canal Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of the Lung

Interventions BCA101 Pembrolizumab

Updated 20 times since 2020 Last updated: Aug 14, 2025 Started: Jun 1, 2020 Primary completion: Dec 31, 2026 Completion: Jun 1, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Carcinoma, Squamous Cell and Colorectal Cancer and is currently actively recruiting participants. Bicara Therapeutics leads this study, which shows 20 recorded versions since 2020 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

20 versions recorded

Sep 2025 — Present [monthly]

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Feb 2025 — Sep 2025 [monthly]

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Dec 2024 — Feb 2025 [monthly]

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Oct 2024 — Dec 2024 [monthly]

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Sep 2024 — Oct 2024 [monthly]

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▶ Show 15 earlier versions

Jul 2024 — Sep 2024 [monthly]

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Feb 2024 — Jul 2024 [monthly]

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Aug 2023 — Feb 2024 [monthly]

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Jun 2023 — Aug 2023 [monthly]

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Oct 2022 — Jun 2023 [monthly]

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Sep 2022 — Oct 2022 [monthly]

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Jul 2022 — Sep 2022 [monthly]

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Mar 2022 — Jul 2022 [monthly]

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Nov 2021 — Mar 2022 [monthly]

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Oct 2021 — Nov 2021 [monthly]

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Feb 2021 — Oct 2021 [monthly]

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Jan 2021 — Feb 2021 [monthly]

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Oct 2020 — Jan 2021 [monthly]

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Aug 2020 — Oct 2020 [monthly]

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Jul 2020 — Aug 2020 [monthly]

Recruiting PHASE1

First recorded

Jun 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bicara Therapeutics
Merck Sharp & Dohme LLC

Data source: Bicara Therapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Boston, United States , Camperdown, Australia , Charleston, United States , Charlotte, United States , Cleveland, United States , Heidelberg, Australia , Houston, United States , La Jolla, United States , Los Angeles, United States , Melbourne, Australia and 8 more locations