Study of BG-C9074 as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233942
• Other study ID #: BG-C9074-101
• Secondary ID: 2023-509958-65-0
• Status: Recruiting
• Phase: Phase 1
• Start date: April 12, 2024
• Est. completion date: September 28, 2027

Study information

• Verified date: June 2024
• Source: BeiGene
• Contact: Study Director
• Phone: 1.877.828.5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 tislelizumab in participants with advanced solid tumors. Participants will receive study drug(s) until progressive disease, unacceptable toxicity, withdrawal of consent, death, or another discontinuation criterion is met, whichever occurs first. The maximum length of receiving study drug(s) for a participant is up to 2 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 28, 2027
• Est. primary completion date: September 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 been previously treated.

4. = 1 measurable lesion per RECIST v1.1.

5. Able to provide an archived tumor tissue sample.

6. Adequate 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 B7H4-targeting antibody drug conjugates (ADC)

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 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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• BG-C9074
administered by intravenous infusion
• Tislelizumab
administered by intravenous infusion

Locations

Country	Name	City	State
Australia	Peter Maccallum Cancer Centre	Melbourne	Victoria
Australia	Linear Clinical Research	Nedlands	Western Australia
Australia	Macquarie University	North Ryde	New South Wales
Australia	Cancer Care Wollongong	Wollongong	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.	Approximately 3 years
Primary	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
Primary	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
Primary	Phase 1b: Overall Response Rate (ORR)	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
Primary	Phase 1b: Recommended Phase 2 dose (RP2D) of BG-C9074	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	Phase 1a: ORR	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
Secondary	Duration of Response (DOR)	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.	Approximately 3 years
Secondary	Disease Control Rate (DCR)	DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease.	Approximately 3 years
Secondary	Clinical Benefit Rate (CBR)	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.	Approximately 3 years
Secondary	Phase 1b: Progression Free Survival (PFS)	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.	Approximately 3 years
Secondary	Phase 1b: Number of Participants with AEs and SAEs	Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.	Approximately 3 years
Secondary	Maximum observed plasma concentration (Cmax) for BG-C9074		Approximately 3 years
Secondary	Minimum observed plasma concentration (Cmin) for BG-C9074		Approximately 3 years
Secondary	Time to maximum plasma concentration (Tmax) for BG-C9074		Approximately 3 years
Secondary	Half-life (t1/2) for BG-C9074		Approximately 3 years
Secondary	Area under the concentration-time curve (AUC) for BG-C9074		Approximately 3 years
Secondary	Apparent clearance (CL/F) for BG-C9074		Approximately 3 years
Secondary	Apparent volume of distribution (Vz/F) for BG-C9074		Approximately 3 years
Secondary	Accumulation ratio for BG-C9074		Approximately 3 years
Secondary	Plasma concentrations for BG-C9074		Approximately 3 years
Secondary	Number of participants with anti-drug antibodies (ADAs) to BG-C9074		Approximately 3 years
Secondary	Serum concentration of BG-C0974		Approximately 3 years