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

Part of paid clinical trials in La Jolla, California.

Sponsor
Bicara Therapeutics
Study ID
NCT04429542
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BCA101 — DRUG
    EGFR/TGFβ fusion monoclonal antibody
  • Pembrolizumab — DRUG
    anti-PD-1

Study Details

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.

Key Dates

Start date
Jun 1, 2020
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
292 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BCA101 Monotherapy
    Route: IV Infusion Frequency: QW Current Dose: 1500mg
  • Experimental: BCA101 + pembrolizumab
    Route: IV Infusion Frequency: Q3W Dose: 200mg

Primary Outcome Measure

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

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Moores Cancer Center UC San Diego HealthLa JollaCalifornia92093
Debanjali Ghosh
[email protected]
858.246.0357
Assuntina Sacco, MD (PRINCIPAL_INVESTIGATOR)
Keck School of Medicine of USCLos AngelesCalifornia90033
Gino In, MD (PRINCIPAL_INVESTIGATOR)
UCLALos AngelesCalifornia90095
Deborah Wong, MD (PRINCIPAL_INVESTIGATOR)
University of California, Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Andrew Birkeland, MD
Andrew Birkeland, MD (PRINCIPAL_INVESTIGATOR)
H. Lee Moffitt Cancer Center and Research Institute, IncTampaFlorida33612
Hamza Elmohd
[email protected]
(813)-745-5554
Christine Chung, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber/Partners Cancer Care IncBostonMassachusetts02115
DFCI Clinical Trials Hotline
8773387425
Glenn Hanna, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032
CPDM Nurse Navigator
[email protected]
2123425162
Catherine Shu, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan KetteringNew YorkNew York10017
646-608-3759
Paul Paik, MD (PRINCIPAL_INVESTIGATOR)
Levine Cancer InstituteCharlotteNorth Carolina28204
Daniel R Carrizosa, MD, MS, FACP
980-442-3213
Cleveland ClinicClevelandOhio44195
[email protected]
(866) 223-8100
Tamara Sussman, MD (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Sarah Brodeur
[email protected]
Dan Zanberg, MD (PRINCIPAL_INVESTIGATOR)
Rhode Island HospitalProvidenceRhode Island02903
Ariel Birnbaum, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina, Hollings Cancer CenterCharlestonSouth Carolina29425
Lilli Neal
[email protected]
8437928113
Carly Fecio
[email protected]
8437923479
John Kaczmar, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Jennifer Choe, MD, PhD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Beryl Tross
[email protected]
7137450774
Van Morris, MD (PRINCIPAL_INVESTIGATOR)

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Moores Cancer Center UC San Diego Health· La Jolla, CAKeck School of Medicine of USC· Los Angeles, CAUCLA· Los Angeles, CAUniversity of California, Davis Comprehensive Cancer Center· Sacramento, CAH. Lee Moffitt Cancer Center and Research Institute, Inc· Tampa, FLDana Farber/Partners Cancer Care Inc· Boston, MA

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