Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
NCT04429542 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 292
Last updated 2025-08-15
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.
Conditions
- Head and Neck Squamous Cell Carcinoma
- Squamous Cell Carcinoma of Anal Canal
- Colorectal Cancer
- Squamous Cell Carcinoma of the Lung
- EGFR Amplification
- Epithelial Ovarian Cancer
- Pancreas Cancer
- Cutaneous Squamous Cell Carcinoma
- Head and Neck Neoplasms
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
Interventions
- DRUG
-
BCA101
EGFR/TGFβ fusion monoclonal antibody
- DRUG
-
anti-PD-1
Sponsors & Collaborators
- collaborator INDUSTRY
-
Bicara Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-06-01
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
Study Locations
More Related Trials
-
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
NCT03783442 ·Status: COMPLETED ·Phase: PHASE3
-
Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer
NCT03099382 ·Status: COMPLETED ·Phase: PHASE3
-
Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy(nCT) in the Treatment of Esophageal Squamous Cell Carcinoma
NCT07312578 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer
NCT03732508 ·Status: UNKNOWN ·Phase: PHASE2
-
NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer
NCT04615013 ·Status: RECRUITING ·Phase: PHASE1
-
Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma
NCT00964080 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma
NCT03957590 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
NCT04974047 ·Status: COMPLETED ·Phase: PHASE2
-
Tislelizumab Combined With Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma Followed by CRT or Surgery
NCT07046221 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
NCT04210115 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Combination Chemotherapy and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer
NCT00281788 ·Status: COMPLETED ·Phase: PHASE1
-
Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach
NCT02358863 ·Status: TERMINATED ·Phase: NA
-
Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus
NCT03792347 ·Status: COMPLETED ·Phase: PHASE1
-
NeoAdjuvant Therapy With Immunoreagent (SHR-1316) for Resectable Oesophageal Squamous Cell carciNoma
NCT04215471 ·Status: UNKNOWN ·Phase: PHASE2
-
A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination With Chemotherapy for Organ Preservation in Esophageal Cancer
NCT06869226 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Anti-PD-1 Antibody SHR-1210 Plus Nimotuzumab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
NCT03766178 ·Status: UNKNOWN ·Phase: PHASE2
-
Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
NCT01197885 ·Status: COMPLETED ·Phase: PHASE2
-
PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer
NCT00669292 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
DCF Combined With Camrelizumab in the Treatment of Esophageal Cancer
NCT05050760 ·Status: UNKNOWN ·Phase: NA
-
Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
NCT06165380 ·Status: RECRUITING ·Phase: PHASE2
-
Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction
NCT05865132 ·Status: RECRUITING ·Phase: PHASE2
-
Autologous Tumor Tissue Antigen-sensitized DC-CIK Cells Combined With Chemotherapy for Esophageal Cancer
NCT02644863 ·Status: UNKNOWN ·Phase: PHASE2
-
Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus
NCT02254044 ·Status: TERMINATED ·Phase: PHASE1
-
Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma
NCT00570531 ·Status: TERMINATED ·Phase: PHASE2
-
Neoadjuvant Chemoradiotherapy Combined With PD-1 Antibody in Locally Advanced Esophageal Cancer
NCT04177875 ·Status: UNKNOWN ·Phase: PHASE2