Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06233942

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

Led by BeOne Medicines · Updated on 2026-04-15

308

Participants Needed

38

Research Sites

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide signed and dated written informed consent before any study procedures
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors
  • Previously received standard systemic therapy with no curative treatment options available or tolerated
  • Enrollment limited to hormone receptor-positive/HER2-negative breast cancer, cholangiocarcinoma, endometrial cancer, squamous non-small cell lung cancer, triple-negative breast cancer, or ovarian cancer
  • Japan cohort limited to hormone receptor-positive/HER2-negative breast cancer, triple-negative breast cancer, endometrial cancer, or ovarian cancer
  • At least one measurable lesion per RECIST v1.1 criteria
  • Able to provide an archived tumor tissue sample
  • Adequate bone marrow and organ function
  • Females of childbearing potential willing to use highly effective birth control during the study and for at least 7 months after last dose
  • Nonsterile males willing to use highly effective birth control during treatment and for at least 4 months after last dose
Not Eligible

You will not qualify if you...

  • Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate or ADC with a topoisomerase 1 inhibitor payload
  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Any malignancy within 2 years before first dose except the specific cancer studied and certain locally recurring cancers treated with curative intent
  • History of interstitial lung disease or Grade 2 or higher noninfectious pneumonitis
  • Oxygen saturation below 92% at rest or need for supplemental oxygen at baseline
  • Uncontrolled diabetes
  • Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first dose of study treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 38 locations

1

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California, United States, 90089-1019

Actively Recruiting

2

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045-2517

Actively Recruiting

3

Florida Cancer Specialist Research Institute Lake Nona

Orlando, Florida, United States, 32827-7400

Actively Recruiting

4

Sidney Kimmel Comprehensive Cancer At Johns Hopkins

Baltimore, Maryland, United States, 21287

Actively Recruiting

5

James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States, 43210-1240

Actively Recruiting

6

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia, NSW 2148

Actively Recruiting

7

Macquarie University

North Ryde, New South Wales, Australia, NSW 2109

Actively Recruiting

8

Cancer Care Wollongong

Wollongong, New South Wales, Australia, NSW 2500

Actively Recruiting

9

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, QLD 4102

Actively Recruiting

10

Monash Health

Clayton, Victoria, Australia, VIC 3168

Actively Recruiting

11

Cabrini Hospital Malvern

Malvern East, Victoria, Australia, VIC 3144

Actively Recruiting

12

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, VIC 3000

Actively Recruiting

13

Linear Clinical Research

Nedlands, Western Australia, Australia, WA 6009

Actively Recruiting

14

Hospital Sirio Libanes Brasilia

Brasília, Brazil, 70200-730

Actively Recruiting

15

Liga Norte Riograndene Contra O Cancer

Natal, Brazil, 59062-000

Actively Recruiting

16

Hospital Sao Lucas Da Pucrs

Porto Alegre, Brazil, 90610-000

Actively Recruiting

17

Instituto Nacional de Cancer Hospital Do Cancer Ii

Rio de Janerio, Brazil, 20220-410

Actively Recruiting

18

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, Brazil, 15090-000

Actively Recruiting

19

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

São Paulo, Brazil, 01246-000

Actively Recruiting

20

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

São Paulo, Brazil, 01318-001

Actively Recruiting

21

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

22

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014

Actively Recruiting

23

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

24

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150000

Actively Recruiting

25

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

Wuhan, Hubei, China, 430022

Actively Recruiting

26

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

Wuhan, Hubei, China, 430030

Actively Recruiting

27

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China, 116023

Actively Recruiting

28

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

29

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China, 110042

Actively Recruiting

30

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250000

Actively Recruiting

31

Affiliated Hospital of Jining Medical University

Jining, Shandong, China, 272000

Actively Recruiting

32

Weifang Peoples Hospital

Weifang, Shandong, China, 261000

Actively Recruiting

33

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200011

Actively Recruiting

34

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

35

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Completed

36

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

37

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

Actively Recruiting

38

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, Japan, 135-8550

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

7

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