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BCA101

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment292
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04429542Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid TumorsPHASE1 RECRUITING 292Jun 1, 2020Jun 1, 2027Aug 15, 202520 United States, Australia +1
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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
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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
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Eligibility Criteria
Age Range18 Years — 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
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04429542primaryCompletionDate: changed
LOWMay 24, 2026NCT04429542studyFirstPostDate: changed