EGFR 유도 진행성 고형암 환자를 위한 BCA101 단독 요법 및 펨브롤리주맙 병용 요법의 안전성과 내어성 연구¶
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
안내
이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.
| 항목 | 내용 |
|---|---|
| 등록번호 | NCT04429542 |
| 상태 | 모집 중 |
| 단계 | 1상 |
| 시험 약물/중재 | BCA101, Pembrolizumab |
| 대상 질환 | 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 |
| 스폰서 | Bicara Therapeutics |
| 연령·성별 | 18 Years ~ 제한 없음 · ALL |
| 목표 인원 | 473 |
| 시작 / 1차 완료 예정 | 2020-06-01 / 2027-10-31 |
| 국내 실시기관 | 없음 |
| 실시 국가 | 3개국, 기관 21곳 (Australia, Canada, United States) |
| 결과 게시 | 아니오 |
| 최근 갱신 | 2026-10-06 |
문의처 (등록된 중앙 연락처)¶
- David Bohr 6178000335 info@bicara.com
국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내
시험 개요¶
이 임상시험은 EGFR과 TGFβ를 동시에 표적하는 최초의(first-in-class) 이중 기능 항체(bifunctional antibody)인 BCA101의 단독 요법 및 pembrolizumab(펨브롤리주맙)과의 병용 요법을 평가하기 위한 제1상/1b상(Phase 1/1b) 공개 연구입니다. 표준 치료에 불응하거나 표준 치료가 없는 EGFR 유도 진행성 고형암 환자를 대상으로 용량 증량(파트 A)과 환자 확장 코호트(파트 B)를 진행합니다. 목표 인원은 총 473명이며, 국내 기관은 포함되지 않았습니다.
- 연구 대상은 EGFR 유도 진행성 고형암 환자이며 목표 인원은 473명입니다.
- BCA101 단독 요법 및 pembrolizumab(펨브롤리주맙) 병용 요법의 안전성과 내성을 평가합니다.
- 연구는 용량 증량 파트(파트 A)와 확장 코호트 파트(파트 B)로 나누어 진행됩니다.
참여 조건 (AI 정리, 원문 확인 필요)¶
선정 기준: • 생검이 가능한 측정 가능한 병변이 있어야 하며, 치료 전 및 치료 중 생검에 동의하고 일차 종양의 보관 조직을 제공할 수 있어야 합니다. • 동유럽종양학협력그룹(ECOG) 성능 상태 평가 점수가 1 이하이어야 합니다. • RECIST 1.1 및 iRECIST 기준에 따른 측정 가능한 병변이 적어도 1개 이상 있어야 합니다. • 파트 B 확장 코호트의 각 암종별 세부 기준(피부 squamous cell carcinoma, 두경부암, 항문관암, 편평세포 비소세포폐암, 대장암 등)을 충족해야 합니다.
제외 기준: • 파트 A의 경우 연구 약물 첫 투여 전 4주 이내에 항 EGFR 항체에 노출된 경우. • 항 TGFβ 치료를 받은 이력이 있는 경우. • cetuximab 또는 기타 항 EGFR 치료제에 대해 2등급 이상의 과민 반응이나 불내성 이력이 있는 경우. • 임신 중이거나 수유 중인 여성. • 연구 약물 첫 투여 전 14일 이내에 전신용 코르티코스테로이드(프레드니손 기준 일 10 mg 초과) 또는 기타 면역억제제 치료가 필요한 상태인 경우. • 이전에 다른 혈액암이나 고형암 진단력이 있는 경우 (완치 후 2년 경과 예외 인정). • CD4+ T세포 수 250 cells/uL 미만인 알려진 인간면역결핍바이러스(HIV) 감염 환자. • 항바이러스 치료를 받고 있지 않은 활동성 만성 B형간염(HBV) 감염 환자.
선정/제외 기준 원문 (영어)
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).
- Tumor eligibility:
PART B (Cohort expansion):
- Single agent BCA101 - patients with the following tumor type will be eligible:
• Expansion Cohort 1: Cutaneous Squamous Cell Carcinoma (CSCC) - i. patients must have received (or been intolerant to or ineligible for) prior anti-PD-1 therapy in the metastatic or locally advanced setting.
ii. No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed). 2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:
• Expansion Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) equal to or greater than 1, as determined by an CLIA-approved laboratory test. Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology).
i. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).
ii. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
iii. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer * Expansion Cohort 3: Squamous Carcinoma of the Anal Canal (SCAC), locally advanced/unresectable or metastatic.
i. Patients must have received (or been intolerant to or ineligible for) at least 1 prior line of chemotherapy and received no more than 2 prior lines of systemic treatments for treatment of unresectable and/or metastatic disease. No prior history of immune checkpoint inhibitors.
- Expansion Cohort 5: Squamous Non-Small Cell Lung Cancer (SqNSCLC) i. Patients must have a histologically or cytologically confirmed diagnosis of stage IV (AJCC 8th edition) squamous NSCLC. Patients with mixed histology (e.g., adenosquamous) are not allowed.
ii. Patients must have progressed on one prior systemic therapy in the metastatic setting.
iii. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.
• Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx. 3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab • Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.
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
출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06
댓글 기능은 아직 설정 전입니다 (관리자: docs/SETUP.md의 giscus 항목 참고). 의견은 GitHub Discussions에 남겨 주세요.