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A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

ConditionsSolid TumorsAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in participants with advanced solid tumors. The study will be conducted in 2 phases: Phase 1a (dose escalation and safety expansion) and Phase 1b (dose expansion).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to therapy with curative intent or for whom treatment is not available or not tolerated.

Participants must be able to provide archival tissue formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue or approximately 10 to 15 freshly cut unstained FFPE slides) or recently obtained fresh tumor biopsy samples at screening.

Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1, as assessed ≤ 14 days before the first dose of study drug.

Disqualifiers

History of severe allergic reactions or hypersensitivity to BG-T187 or other monoclonal antibodies, or to the active ingredient and excipients of the study drug or camptothecins.

For Phase 1a Part B Safety Expansion and Phase 1b only: Prior treatment with an EGFR-targeting ADC or mesenchymal-epithelial transition (MET)-targeting antibody-drug conjugate (ADC), or any ADC with topoisomerase I (TOPO1) inhibitor payload.

Brain imaging at screening shows no evidence of interim progression, is clinically stable for ≥ 4 weeks, and has no evidence of new brain metastases

Have measurable disease and/or evaluable disease outside CNS

Trial design

Design model

Sequential

Treatments tested in this trial

  • BG-C0902

    Drug

    Administered by intravenous infusion

Treatment groups

63 Participants
are divided into 2 treatment groups
Group A: Phase 1a: Dose Escalation and Safety Expansion of BG-C0902Experimental treatment 1 intervention
Group B: Phase 1b: Dose Expansion of BG-C0902Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
Approximately 24 Months
2

Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs)

Time frame
Approximately 21 Days
3

Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902

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 24 Months
4

Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902

RDFE of BG-C0902 will be determined based upon the MTD or MAD.

Time frame
Approximately 24 Months

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 using RECIST v1.1.

Time frame
Approximately 24 Months
2

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

DOR is defined as the time from the first confirmed objective response by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first.

Time frame
Approximately 24 Months
3

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

DCR is defined as the percentage of participants with the best overall response, of a CR, PR, and stable disease assessed by the investigator using RECIST v1.1.

Time frame
Approximately 24 Months
4

Phase 1b: Progression-free Survival (PFS)

PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1

Time frame
Approximately 24 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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