Health TrialsbyHealthPanel

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

ConditionAdvanced Solid Tumor
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 (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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.

Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BG-C0979

    Drug

    Administered by intravenous infusion.

  • Tislelizumab

    Drug

    Administered by intravenous infusion.

Treatment groups

84 Participants
are divided into 4 treatment groups
Group A: Phase 1a: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1a: Monotherapy Safety ExpansionExperimental treatment 1 intervention
Group C: Phase 1b, Part A: Monotherapy Dose Optimization and Dose ExpansionExperimental treatment 1 intervention
Group D: Phase 1b, Part B: Combination Therapy ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

Phase 1a: Plasma Concentration of BG-C0979

Time frame
Up to approximately 3 months

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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