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A Study of BG-C477 in Participants With Advanced Solid Tumors

PHASE1RECRUITING

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

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Study details:

This new study will check how safe and helpful a potential anticancer drug called BG-C477 is. This drug will be tested by itself or combined with other anticancer agents. The purpose of this study is to test if BG-C477 is safe and if it works in people with your disease when it is given on its own and in combination with other anticancer agents.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Participants must sign the informed consent form (ICF) and be capable of giving written informed consent

Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy

Phase 1a (Dose Escalation); Histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, who were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator

≥ 1 measurable lesion as assessed by RECIST v1.1

Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Adequate organ function

Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477 and for ≥ 6 months after the last dose of chemotherapy, whichever comes later

Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, and for ≥ 3 months after chemotherapy, whichever comes later.

Exclusion criteria

Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload

History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics

Active leptomeningeal disease or uncontrolled, untreated brain metastasis

Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-03

Primary completion: 2028-10-27

Study completion finish: 2028-10-27

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06596473

Intervention or treatment

DRUG: BG-C477

DRUG: Chemotherapy

Conditions

• Advanced Solid Tumors

Condition: Advanced Solid Tumors
DRUG: BG-C477 and other drugs
Melbourne, Victoria, Australia and more
Sponsor: BeiGene

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Alfred Hospital

Research sites nearby

Select from list below to view details:

The Alfred Hospital
Melbourne, Victoria, Australia
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase 1a: BG-C477 Monotherapy Dose Escalation Sequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy.	DRUG: BG-C477 Administered intravenously.
EXPERIMENTAL: Phase 1a: BG-C477 Monotherapy Safety Expansion Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy.	DRUG: BG-C477 Administered intravenously.
EXPERIMENTAL: Phase 1b Part A: BG-C477 Monotherapy Dose Optimization Participants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a.	DRUG: BG-C477 Administered intravenously.
EXPERIMENTAL: Phase 1b Part B: Combination Therapy Expansion Sequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with capecitabine with or without bevacizumab.	DRUG: BG-C477 Administered intravenously.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of participants with AEs and SAEs, including findings from abnormal laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Special Interest (AESI) criteria.	From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)	MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.	Approximately 1 year
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477	RDFE of BG-C477 monotherapy will be determined based upon available data.	Approximately 1 year
Phase 1b: Objective Response Rate (ORR)	ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.	Approximately 2 years
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477	RP2D established from Phase 1a for BG-C477 for administration alone and in combination with chemotherapy.	Approximately 2 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Phase 1a: ORR	ORR is defined as the percentage of participants with best overall response of CR or PR, as assessed by the investigator per RECIST v1.1.	Approximately 1 year
Phase 1a and 1b: Duration of Response (DOR)	DOR is defined as the time from the first determination of an objective response until first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.	Approximately 2 years
Phase 1a and 1b: Disease Control Rate (DCR)	DCR is defined as the percentage of participants who achieve best overall response of CR, PR, or stable disease, as assessed by the investigator per RECIST Version 1.1.	Approximately 2 years
Phase 1b: Progression-Free Survival (PFS)	PFS is defined as the time from the first administration of study drug(s) to the date of first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.	Approximately 2 years
Phase 1b: Number of Participants with AEs and SAEs	Number of participants with AEs and SAEs, including findings from physical examinations, laboratory assessments, and that meet protocol-defined DLT criteria or protocol-defined AESI criteria.	From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-C477 antibody-drug conjugate (ADC), BG-C477 total antibody, and free payload	Not Specified	Approximately 2 years
Phase 1a and 1b: Minimum concentration (Cmin) of BG-C477	Not Specified	Approximately 2 years
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-C477	Not Specified	Approximately 2 years
Phase 1a and 1b: Area under the concentration-versus-time curve during dosing interval (AUCtau) of BG-C477	Not Specified	Approximately 2 years
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-C477	Not Specified	Approximately 2 years
Phase 1a and 1b: Systemic clearance (CL/F) of BG-C477	Not Specified	Approximately 2 years
Phase 1a and 1b: Apparent volume of distribution at steady state (Vss) of BG-C477	Not Specified	Approximately 2 years
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BG-C477	Not Specified	Approximately 2 years

Frequently Asked Questions

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References

Clinical Trials Gov: A Study of BG-C477 in Participants With Advanced Solid Tumors