Clinical trial NCT06596473: A Study of BG-C477 in Participants With Advanced Solid Tumors
Official title: A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: BG-C477
advanced solid tumors
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
measure: Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
timeFrame: Approximately 1 year
measure: Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477
timeFrame: Approximately 1 year
measure: Phase 1b: Objective Response Rate (ORR)
timeFrame: Approximately 2 years
measure: Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Phase 1a: ORR
timeFrame: Approximately 1 year
measure: Phase 1a and 1b: Duration of Response (DOR)
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Disease Control Rate (DCR)
timeFrame: Approximately 2 years
measure: Phase 1b: Progression-Free Survival (PFS)
timeFrame: Approximately 2 years
measure: Phase 1b: Number of Participants with AEs and SAEs
timeFrame: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
measure: Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-C477 antibody-drug conjugate (ADC), BG-C477 total antibody, and free payload
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Minimum concentration (Cmin) of BG-C477
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-C477
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Area under the concentration-versus-time curve during dosing interval (AUCtau) of BG-C477
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-C477
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Systemic clearance (CL/F) of BG-C477
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Apparent volume of distribution at steady state (Vss) of BG-C477
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BG-C477
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: New Haven
country: United States
facility: Yale University, Yale Cancer Center
state: Connecticut
city: Westwood
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Houston
country: United States
facility: The University of Texas Md Anderson Cancer Center
state: Texas
city: Blacktown
country: Australia
facility: Blacktown Cancer and Haematology Centre
state: New South Wales
city: Adelaide
country: Australia
facility: Cancer Research South Australia
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research
state: Western Australia
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat Sen University
state: Guangdong
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: