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

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

NCT ID: NCT06596473

Condition: Advanced Solid Tumors

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
BG-C477
advanced solid tumors

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: BG-C477
Description: Administered intravenously.
Arm group label: Phase 1a: BG-C477 Monotherapy Dose Escalation
Arm group label: Phase 1a: BG-C477 Monotherapy Safety Expansion
Arm group label: Phase 1b Part A: BG-C477 Monotherapy Dose Optimization
Arm group label: Phase 1b Part B: Combination Therapy Expansion

Intervention type: Drug
Intervention name: Chemotherapy
Description: Administered in accordance with relevant local guidelines and/or prescribing information.
Arm group label: Phase 1b Part B: Combination Therapy Expansion

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Blacktown Cancer and Haematology Centre

Address:
City: Blacktown
Zip: 2148
Country: Australia

Status: Recruiting

Facility:
Name: Cancer Research South Australia

Address:
City: Adelaide
Zip: 5000
Country: Australia

Status: Recruiting

Facility:
Name: The Alfred Hospital

Address:
City: Melbourne
Zip: 3004
Country: Australia

Status: Recruiting

Start date: October 3, 2024

Completion date: October 27, 2028

Lead sponsor:
Agency: BeiGene
Agency class: Industry

Source: BeiGene

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06596473