Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors

NCT06233942 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: BG-C9074-101jRCT2031250755
• Study Type: interventional
• Target: 308
• Locations: 5 countries
• Sites: 37

Brief Summary

This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other anticancer therapies in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

BG-C9074; Tislelizumab; Advanced Solid Tumors; first-in-human; B7H4

Outcome Measures

Primary Outcomes (5)

• Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Number of participants with AEs and SAEs (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] Version \[v\] 5.0),, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.

  Approximately 3 years

• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C9074

  Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28% or the highest dose administered, respectively

  Approximately 18 months

• Phase 1a: Recommended Dose for Expansion (RDFE) of BG-C9074.

  The potential RDFE(s) of BG-C9074 alone and in combination with tislelizumab will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, PK, pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available

  Approximately 18 months

• Phase 1b: Overall Response Rate (ORR) as monotherapy and in combination with tislelizumab

  ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.

  Approximately 3 years

• Phase 1b: Recommended Phase 2 dose (RP2D) of BG-C9074 as monotherapy and in combination with bevacizumab or tislelizumab

  The RP2D of BG-C9074 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.

  Approximately 30 months

Secondary Outcomes (24)

• Phase 1a: ORR as monotherapy and in combination with tislelizumab

  Approximately 3 years

• Phase 1b: ORR as monotherapy and in combination with bevacizumab or tislelizumab

  Approximately 3 years

• Phase 1b: ORR per B7-H4 (B7 homolog 4) protein expression

  Approximately 3 years

• Duration of Response (DOR)

  Approximately 3 years

• Duration of Response (DOR) per B7-H4 protein expression

  Approximately 3 years

Study Arms (7)

Phase 1a: Part A (Monotherapy Dose Escalation)

EXPERIMENTAL

BG-C9074 monotherapy dose escalation

Drug: BG-C9074

Phase 1a: Part B (Monotherapy Safety Expansion)

EXPERIMENTAL

BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated.

Drug: BG-C9074

Phase 1a: Part C (Combination Therapy Dose Escalation)

EXPERIMENTAL

BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE).

Drug: BG-C9074; Drug: Tislelizumab

Phase 1a: Part D (Japan Cohort)

EXPERIMENTAL

A separate cohort in Japan will evaluate the safety of BG-C9074 monotherapy in Japanese participants with select solid tumors

Drug: BG-C9074

Phase 1b: Monotherapy Dose Expansion

EXPERIMENTAL

The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a.

Drug: BG-C9074

Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus tislelizumab)

EXPERIMENTAL

This arm will assess BG-C9074 plus tislelizumab as first-line therapy in select solid tumors after completion of the dose escalation phase.

Drug: BG-C9074; Drug: Tislelizumab

Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus bevacizumab)

EXPERIMENTAL

This arm will assess BG-C9074 plus bevacizumab in select solid tumors participants after establishing the recommended monotherapy dose and schedule.

Drug: BG-C9074; Drug: Bevacizumab

Interventions

BG-C9074 DRUG

administered by intravenous infusion

Phase 1a: Part A (Monotherapy Dose Escalation); Phase 1a: Part B (Monotherapy Safety Expansion); Phase 1a: Part C (Combination Therapy Dose Escalation); Phase 1a: Part D (Japan Cohort); Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus bevacizumab); Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus tislelizumab); Phase 1b: Monotherapy Dose Expansion

Tislelizumab DRUG

administered by intravenous infusion

Phase 1a: Part C (Combination Therapy Dose Escalation); Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus tislelizumab)

Bevacizumab DRUG

administered by intravenous infusion

Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus bevacizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
• Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy and whose cancer is not amenable to therapy with curative intent, and for whom further treatment is not available or not tolerated. Enrollment will be limited to participants with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer, cholangiocarcinoma (CCA), endometrial cancer, squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or ovarian cancer. Enrollment in the Japan cohort will be limited to participants with HR+/HER2- breast cancer, TNBC, endometrial cancer, or ovarian cancer.
• ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
• Able to provide an archived tumor tissue sample.
• Adequate bone marrow and organ function.
• Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).
• Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).

You may not qualify if:

• Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload.
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis
• Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
• History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.
• Uncontrolled diabetes.
• Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (37)

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California, 90089-1019, United States

RECRUITING

University of Colorado Cancer Center

Aurora, Colorado, 80045-2517, United States

RECRUITING

Florida Cancer Specialist Research Institute Lake Nona

Orlando, Florida, 32827-7400, United States

RECRUITING

Sidney Kimmel Comprehensive Cancer At Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

James Cancer Hospital and Solove Research Institute

Columbus, Ohio, 43210-1240, United States

RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

RECRUITING

Macquarie University

North Ryde, New South Wales, NSW 2109, Australia

RECRUITING

Cancer Care Wollongong

Wollongong, New South Wales, NSW 2500, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, QLD 4102, Australia

RECRUITING

Monash Health

Clayton, Victoria, VIC 3168, Australia

RECRUITING

Cabrini Hospital Malvern

Malvern, Victoria, VIC 3144, Australia

RECRUITING

Peter Maccallum Cancer Centre

Melbourne, Victoria, VIC 3000, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, WA 6009, Australia

RECRUITING

Hospital Sirio Libanes Brasilia

Brasília, 70200-730, Brazil

RECRUITING

Liga Norte Riograndene Contra O Cancer

Natal, 59062-000, Brazil

RECRUITING

Hospital Sao Lucas Da Pucrs

Porto Alegre, 90610-000, Brazil

RECRUITING

Instituto Nacional de Cancer Hospital Do Cancer Ii

Rio de Janerio, 20220-410, Brazil

RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, 15090-000, Brazil

RECRUITING

Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

São Paulo, 01246-000, Brazil

RECRUITING

Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria

São Paulo, 01318-001, Brazil

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

RECRUITING

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272000, China

RECRUITING

Weifang Peoples Hospital

Weifang, Shandong, 261000, China

RECRUITING

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, 135-8550, Japan

RECRUITING

MeSH Terms

Interventions

tislelizumab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: April 12, 2024
• Primary Completion (Estimated): September 28, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

BR (7); CN (15); AU (8); US (5); JP (2)