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

PHASE1RECRUITING

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.

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Study details:

This is a Phase 1/1b, open-label study, which consists of dose escalation parts (Part A) followed by expansion cohorts (Part B) for both single agent BCA101 and combination BCA101 plus pembrolizumab. The study population in dose escalation (Part A) of single agent BCA101 consists of subjects with EGFR-driven advanced solid tumors refractory to standard of care or for whom no standard of care is available. Dose escalation (Part A) of combination BCA101 and pembrolizumab consists of subjects with either Squamous Cell Carcinoma of the Head and Neck (HNSCC) or Squamous Cell Carcinoma of the Anal Canal (SCCAC) whose tumors are refractory to standard of care or for whom no standard of care is available.

Once the maximum tolerated dose (MTD) / recommended dose (RD) of single agent BCA101 is determined, the study will continue with expansion cohorts (Part B) with select tumor types. Expansion cohorts for single agent BCA101 will include cutaneous squamous cell carcinoma. Planned expansion cohorts for the combination of BCA101 and pembrolizumab include: 1) HNSCC and 2) SCCAC.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 sections of 4 to 5 micrometer thickness).

Patient must have a performance status of ≤1 on the Eastern Cooperative Oncology Group Performance Scale.

Patients must have evaluable or measurable disease (computed tomography [CT]/magnetic resonance imaging [MRI] scans performed within 21 days before the screening visit are acceptable) demonstrating measurable disease, i.e., at least 1 unidimensional measurable lesion as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST).

Exclusion criteria

For Part A: Exposure to anti-EGFR antibodies within 4 weeks of the first dose of study drug.

Prior treatment with any anti-TGFβ therapy.

Prior history of Grade ≥ 2 intolerance or hypersensitivity reaction to cetuximab or other anti-EGFR therapy or other murine proteins or prior discontinuation of therapy in the setting of toxicity related to treatment.

Pregnant or breastfeeding women.

Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study drug, with the exception of topical, intranasal, intrabronchial, or ocular steroids.

Known history of a hematologic malignancy (or solid tumor other than the ones indicated for this study), unless the patient has undergone potentially curative therapy with no evidence of that disease for 2 years. Does not include tumors with a negligible risk of metastasis or death (e.g. adequately treated basal or squamous cell carcinoma, stage 1 prostate cancer, or carcinoma in situ of the cervix or carcinoma in situ of the breast). Subjects enrolling in the CSCC cohort may have chronic lymphocytic leukemia as long as the patient is not on active treatment.

Known cases of human immunodeficiency virus (HIV) are excluded if patients have a CD4+ T-cell (CD4+) count <250 cells/uL. To ensure that effective antiretroviral therapy (ART) is tolerated and that toxicities are not confused with investigational drug toxicities, trial participants should be on established ART for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.

Patients with chronic HBV infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment.

Patients with a known history of hepatitis C who have not completed curative antiviral treatment or have a HCV viral load above the limit of quantification.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-06-01

Primary completion: 2026-12-31

Study completion finish: 2027-06-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT04429542

Intervention or treatment

DRUG: BCA101

DRUG: Pembrolizumab

Conditions

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

Image related to Head and Neck Squamous Cell Carcinoma

Condition: Head and Neck Squamous Cell Carcinoma, Colorectal Cancer and more
DRUG: BCA101 and other drugs
Waratah, New South Wales, Australia and more
Sponsor: Bicara Therapeutics

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Calvary Mater Newcastle

Research sites nearby

Select from list below to view details:

Calvary Mater Newcastle
Waratah, New South Wales, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BCA101 Monotherapy Route: IV Infusion Frequency: QW Current Dose: 1500mg	DRUG: BCA101 EGFR/TGFβ fusion monoclonal antibody
EXPERIMENTAL: BCA101 + pembrolizumab Route: IV Infusion Frequency: Q3W Dose: 200mg	DRUG: BCA101 EGFR/TGFβ fusion monoclonal antibody

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs	Incidence and severity of AEs and SAEs	24 months
Tolerability of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs	Incidence and severity of AEs and SAEs	24 months
Incidence of Dose Limiting Toxicities (DLTs)	Incidence of DLTs during the first cycle of treatment with BCA101 monotherapy or the combination of BCA101 and pembrolizumab.	21 days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Objective Response Rate	Determine objective response rate in each part of the study, per RECIST v1.1 and iRECIST	24 months
Clinical Benefit Rate	Determine clinical benefit rate in each part of the study, per RECIST v1.1 and iRECIST	24 months
Progression free survival	Determine PFS in each part of the study, per RECIST v1.1 and iRECIST	24 months
Duration of Response	Determine duration of response in each part of the study, per RECIST v1.1 and iRECIST	24 months
Overall Survival	Determine survival rates in each part of the study.	24 months
AUC of BCA101 and pembrolizumab	AUC	24 months
Cmax of BCA101 and pembrolizumab	Cmax	24 months
Tmax of BCA101 and pembrolizumab	Tmax	24 months
Concentration vs time profile of BCA101 and pembrolizumab	Ctrough	24 months
Half-life of BCA101 and pembrolizumab	Half-life	24 months
Immunogenicity of BCA101 and pembrolizumab	Incidence and titer of anti-drug-antibodies	24 months

Frequently Asked Questions

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References

Clinical Trials Gov: Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients with EGFR-driven Advanced Solid Tumors