Recent Updates
Recently added Catalysts

BCA101

Phase 1

Head and Neck Squamous Cell Carcinoma | Small molecule | Oncology |Bicara Therapeutics Inc.|Last Updated: Aug 15, 2025

Target and mechanism

Molecular targetEGFR
Target classProtein
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment292

FDA Designations

No designations recorded

Clinical trial landscape

BCA101 · 1 trial · 11 indications

Phase 1 1
NCT04429542Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid TumorsHead and Neck Squamous Cell Carcinoma
RECRUITING292 Analytics
PHASE1RECRUITING
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
Head and Neck Squamous Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Incidence and severity of AEs and SAEs

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

Incidence and severity of AEs and SAEs

Incidence of Dose Limiting Toxicities (DLTs)
21 days

Incidence of DLTs during the first cycle of treatment with BCA101 monotherapy or the combination of BCA101 and pembrolizumab.

Secondary Endpoints

Objective Response Rate
24 months
Clinical Benefit Rate
24 months
Progression free survival
24 months
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BCA101 MonotherapyEXPERIMENTALRoute: IV Infusion Frequency: QW Current Dose: 1500mg
BCA101 + pembrolizumabEXPERIMENTALRoute: IV Infusion Frequency: Q3W Dose: 200mg

Interventions

NameTypeDescription
BCA101DRUGEGFR/TGFβ fusion monoclonal antibody
PembrolizumabDRUGanti-PD-1
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Patient must have measurable disease amendable to biopsy and be willing to undergo both a pre-treatment and on-treatment biopsy, as well as provide archival tumor if available from the primary tumor (a paraffin embedded tumor tissue block sufficient to obtain at least 10 secti...

Countries:United StatesAustraliaCanada
Unlock Eligibility Criteria

Frequently asked questions about BCA101

What is BCA101 used for in Head and Neck Squamous Cell Carcinoma?

BCA101 is an investigational small molecule being studied for the treatment of Head and Neck Squamous Cell Carcinoma. It is currently in Phase 1 clinical development, and its safety and tolerability are being evaluated in patients with EGFR-driven advanced solid tumors, including this indication.

What does BCA101 target?

BCA101 targets EGFR, a protein involved in cell growth and survival that is often overactive in certain cancers. By targeting EGFR, BCA101 is being studied as a potential treatment for EGFR-driven advanced solid tumors, including Head and Neck Squamous Cell Carcinoma.

Who makes BCA101?

BCA101 is being developed by Bicara Therapeutics Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and tolerability of BCA101 in patients with EGFR-driven advanced solid tumors.

What phase is BCA101 in?

BCA101 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and tolerability in patients.

What clinical trials is BCA101 in?

BCA101 is being studied in a Phase 1 clinical trial with the identifier NCT04429542. This trial is evaluating the safety and tolerability of BCA101 as a monotherapy and in combination therapy in patients with EGFR-driven advanced solid tumors, including Head and Neck Squamous Cell Carcinoma.

Is BCA101 the same as any other drug?

BCA101 is the drug name used in clinical development by Bicara Therapeutics Inc. No alternative names for BCA101 have been reported in the clinical trial information, so it is not known to be the same as any other drug.