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

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 confirmed advanced, metastatic, or unresectable solid tumors, that 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

Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy

Disqualifiers

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)

Trial design

Design model

Sequential

Treatments tested in this trial

  • BG-C477

    Drug

    Administered intravenously.

  • Tislelizumab

    Drug

    Administered intravenously.

  • Chemotherapy

    Drug

    Administered in accordance with relevant local guidelines and/or prescribing information.

Treatment groups

310 Participants
are divided into 4 treatment groups
Group A: Phase 1a: BG-C477 Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1a: BG-C477 Monotherapy Safety ExpansionExperimental treatment 1 intervention
Group C: Phase 1b Part A: BG-C477 Monotherapy Expansion and Dose OptimizationExperimental treatment 1 intervention
Group D: Phase 1b Part B: Combination Therapy ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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 Clinical Interest (AECI) criteria.

Time frame
From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
2

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.

Time frame
Approximately 1 year
3

Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477

RDFE of BG-C477 monotherapy will be determined based upon available data.

Time frame
Approximately 1 year
4

Phase 1b: Overall 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.

Time frame
Approximately 2 years

Secondary outcomes

1

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.

Time frame
Approximately 1 year
2

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.

Time frame
Approximately 2 years
3

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.

Time frame
Approximately 2 years
4

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.

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
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