A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors

Phase 1Not Yet RecruitingNCT07414836

BeOne Medicines84 enrolled

Overview

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor

Interventions

BG-C0979DRUG

Administered by intravenous infusion.

TislelizumabDRUG

Administered by intravenous infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment. * Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment. * Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease. * Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1. * Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Participants must have adequate organ function. Exclusion Criteria: * Prior treatment with any ADAM9-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 inhibitor as payload. * Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Outcomes

Primary Outcomes

Phase 1a: Number of Participants Experiencing Adverse Events (AEs)

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results.

Time frame: Up to approximately 24 months

Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy

MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.

Time frame: Up to approximately 10 months

Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])

The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available.

Time frame: Up to approximately 10 months

Phase 1b: Recommended Phase 2 Dose (RP2D)

RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available.

Time frame: Up to approximately 24 months

Phase 1b: Overall Response Rate (ORR)

ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR).

Time frame: Up to approximately 24 months

Central Contacts

Study Director

CONTACT

8778285568 clinicaltrials@beonemed.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Phase 1a: ORR

ORR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, ORR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR).

Time frame: Up to approximately 24 months

Phase 1a and 1b: Duration of Response (DOR)

DOR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DOR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first.

Time frame: Up to approximately 24 months

Phase 1a and 1b: Disease Control Rate (DCR)

DCR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DCR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DCR is defined as the percentage of participants with best overall response of a CR, PR, or stable disease.

Time frame: Up to approximately 24 months

Phase 1a: Plasma Concentration of BG-C0979

Time frame: Up to approximately 3 months

Phase 1a: Area Under the Concentration-Time Curve (AUC) for BG-C0979

Time frame: Up to approximately 3 months

Phase 1a: Maximum Observed Concentration (Cmax) of BG-C0979

Time frame: Up to approximately 3 months

Phase 1a: Time to Maximum Concentration (Tmax) of BG-C0979

Time frame: Up to approximately 3 months

Phase 1a and 1b: Number of Participants with Anti-Drug Antibodies (ADAs)

Time frame: Up to approximately 24 months

Phase 1b: Number of Participants Experiencing Adverse Events (AEs)

Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results.

Time frame: Up to approximately 24 months

Phase 1b: Progression-Free Survival

PFS is defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first.

Time frame: Up to approximately 24 months

Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC

rPFS is defined as the time from the date of the first administration of study drug(s) to the date of the first objective evidence of radiographic disease progression or death due to any cause, whichever occurs first.

Time frame: Up to approximately 24 months

Prostate-Specific Antigen (PSA) Response for Participants with CRPC

PSA response is defined as a ≥50% decrease in PSA level from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.

Time frame: Up to approximately 24 months

Phase 1b: Plasma Concentration of BG-C0979, Alone and in Combination with Tislelizumab

Time frame: Up to approximately 3 months

A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Central Contacts

Secondary Outcomes