A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
BridGene Biosciences Inc.
Study ID
NCT06452160
Phase
PHASE1
Status
Recruiting
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Conditions

  • Epithelioid Hemangioendothelioma(EHE)
  • Mesothelioma
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BGC515 — DRUG
    Capsules for oral administration

Study Details

The goal of this open-label, dose escalation and dose expansion Phase I clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 administered once daily in 3 weeks cycles in solid tumor patients.

Key Dates

Start date
Jun 27, 2024
Status verified
Aug 2024
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
103 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    BGC515 Capsules will be administered orally in 21 day cycles, once daily (QD). Patients will be enrolled into escalating dose levels during the Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose(s) for Expansion (RDE).
  • Experimental: Dose Expansion
    BGC515 Capsules will be administered orally in 21 day cycles at MTD/RDE defined dose,once daily (QD), in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors.

Primary Outcome Measure

Incidence of adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Through study completion, approximately 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Ileana Gutierrez
[email protected]
713-563-2158

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX

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