> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-1a-1b-first-in-human-study-of-bg-c9074-alone-and-in-a57ecf1c-35bb-4c70-9593-82e4ab630702 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) Participants 308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) Lead sponsor BeOne Medicines Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) Start date 2024-04-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) Number of sites 37 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Short 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Official title** Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Dates **Completion date** 2028-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **First posted** 2024-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Registry last updated** 2026-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Primary completion date** 2027-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Start date** 2024-04-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Size and sites **Participants** 308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Planned participants** 308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Number of sites** 37 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Lead sponsor** BeOne Medicines Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Identifiers **Registry ID** NCT06233942 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **ClinicalTrials.gov ID** NCT06233942 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Outcomes ### Primary outcomes 1. Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Approximately 3 years 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. 2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C9074 Timeframe: Approximately 18 months 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 3. Phase 1a: Recommended Dose for Expansion (RDFE) of BG-C9074. Timeframe: Approximately 18 months 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 4. Phase 1b: Overall Response Rate (ORR) as monotherapy and in combination with tislelizumab Timeframe: Approximately 3 years 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. 5. Phase 1b: Recommended Phase 2 dose (RP2D) of BG-C9074 as monotherapy and in combination with bevacizumab or tislelizumab Timeframe: Approximately 30 months The RP2D of BG-C9074 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available. ### Secondary outcomes 1. Phase 1a: ORR as monotherapy and in combination with tislelizumab Timeframe: Approximately 3 years 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. 2. Phase 1b: ORR as monotherapy and in combination with bevacizumab or tislelizumab Timeframe: Approximately 3 years 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. 3. Phase 1b: ORR per B7-H4 (B7 homolog 4) protein expression Timeframe: Approximately 3 years 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 and evaluated according to the amount of B7-H4 (B7 homolog 4) protein expressed in their tumors 4. Duration of Response (DOR) Timeframe: Approximately 3 years Duration of response (DOR) is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first, as assessed by the investigator 5. Duration of Response (DOR) per B7-H4 protein expression Timeframe: Approximately 3 years Duration of response (DOR) is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first, as assessed by the investigator, and evaluated according to the amount of B7-H4 protein expressed in the tumors 6. Disease Control Rate (DCR) Timeframe: Approximately 3 years DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease, as assessed by the investigator 7. Disease Control Rate (DCR) per B7-H4 protein expression Timeframe: Approximately 3 years DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease, as assessed by the investigator, and evaluated according to the amount of B7-H4 protein expressed in the tumors 8. Clinical Benefit Rate (CBR) Timeframe: Approximately 3 years CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator. 9. Clinical Benefit Rate (CBR) per B7-H4 protein expression Timeframe: Approximately 3 years CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigato, and evaluated according to the amount of B7-H4 protein expressed in the tumors 10. Phase 1b: Progression Free Survival (PFS) Timeframe: Approximately 3 years PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first. 11. Phase 1b: Number of Participants with AEs and SAEs Timeframe: Approximately 3 years Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments. 12. Maximum observed plasma concentration (Cmax) for BG-C9074 Timeframe: Twice in the first four months 13. Minimum observed plasma concentration (Cmin) for BG-C9074 Timeframe: Approximately 3 years 14. Time to reach maximum observed plasma concentration (Tmax) for BG-C9074 Timeframe: Twice in the first four months 15. Half-life (t1/2) for BG-C9074 Timeframe: Twice in the first four months 16. Area under the concentration-time curve (AUC) for BG-C9074 Timeframe: Twice in the first four months 17. Apparent clearance (CL/F) for BG-C9074 Timeframe: Twice in the first four months 18. Apparent volume of distribution (Vz/F) for BG-C9074 Timeframe: Twice in the first four months 19. Accumulation ratio for BG-C9074 Timeframe: Twice in the first four months 20. Plasma concentrations for BG-C9074 Timeframe: Approximately 3 years 21. Phase 1a: Number of participants with anti-drug antibodies (ADAs) to BG-C9074 and tislelizumab Timeframe: Approximately 3 years 22. Phase 1b: Number of participants with anti-drug antibodies (ADAs) to BG-C9074 Timeframe: Approximately 3 years 23. Serum concentration of BG-C0974 Timeframe: Approximately 3 years 24. Serum concentration of Tislelizumab Timeframe: Approximately 3 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 3. 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. 4. ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) 5. Able to provide an archived tumor tissue sample. 6. Adequate bone marrow and organ function. 7. 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). 8. 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). ### Exclusion criteria 1. Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload. 2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis 3. 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). 4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen (including intermittent use) at baseline. 5. Uncontrolled diabetes. 6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s). Note: Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Sites - Usc Norris Comprehensive Cancer Center (Nccc)Los Angeles, United StatesRecruiting - University of Colorado Cancer CenterAurora, United StatesRecruiting - Florida Cancer Specialist Research Institute Lake NonaOrlando, United StatesRecruiting - Sidney Kimmel Comprehensive Cancer At Johns HopkinsBaltimore, United StatesRecruiting - James Cancer Hospital and Solove Research InstituteColumbus, United StatesRecruiting - Blacktown Cancer and Haematology CentreBlacktown, AustraliaRecruiting - Macquarie UniversityNorth Ryde, AustraliaRecruiting - Cancer Care WollongongWollongong, AustraliaRecruiting - Princess Alexandra HospitalWoolloongabba, AustraliaRecruiting - Monash HealthClayton, AustraliaRecruiting - Cabrini Hospital MalvernMalvern, AustraliaRecruiting - Peter Maccallum Cancer CentreMelbourne, AustraliaRecruiting - Linear Clinical ResearchNedlands, AustraliaRecruiting - Hospital Sirio Libanes BrasiliaBrasília, BrazilRecruiting - Liga Norte Riograndene Contra O CancerNatal, BrazilRecruiting - Hospital Sao Lucas Da PucrsPorto Alegre, BrazilRecruiting - Instituto Nacional de Cancer Hospital Do Cancer IiRio de Janerio, BrazilRecruiting - Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio PretoSão José do Rio Preto, BrazilRecruiting - Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de OliveiraSão Paulo, BrazilRecruiting - Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E MamariaSão Paulo, BrazilRecruiting - Cancer Hospital Chinese Academy of Medical SciencesBeijing, ChinaRecruiting - Fujian Cancer HospitalFuzhou, ChinaRecruiting - Sun Yat Sen University Cancer CenterGuangzhou, ChinaRecruiting - Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting - Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaRecruiting And 12 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## References ### Other registry identifiers - jRCT2031250755 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233942) ## Related records ### Drugs (2) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Tislelizumab](https://trialight.com/data/asset/tislelizumab-70601caf-7705-4f05-b211-e6a4d4556fe3.md) ### Lead sponsors (1) - [BeOne Medicines](https://trialight.com/data/company/beone-medicines-ca965972-7362-4484-b43f-72a02fc75941.md) ### Targets (2) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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