A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
Hummingbird Bioscience
Study ID
NCT06956690
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • ENV-501 — BIOLOGICAL
    ENV-501 is a HER3-targeted antibody-drug conjugate (ADC) with a humanized monoclonal antibody (mAb) conjugated with a chemotherapeutic payload via a linker.

Study Details

This study is a Phase 1/2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of HMBD-501 in patients with advanced-stage, relapsed and/or refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors. The study consists of 2 phases: a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2). The primary objectives of Phase 1 are to characterize the overall safety and tolerability profile of increasing doses of HMBD-501 in patients with advanced-stage solid tumors and identify the recommended Phase 2 dose (RP2D) of ENV-501. During Phase 1, successive cohorts of patients will receive escalating doses of HMBD-501. The results of the dose escalation will determine the RP2D and dosing schedule of HMBD-501 to be administered in the Phase 2 part of the study. The primary objective of Phase 2 is to evaluate the preliminary clinical efficacy of HMBD-501 in dose expansion cohorts.

Key Dates

Start date
Dec 17, 2025
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HMBD-501
    HMBD-501 intravenous injection once every 3 weeks; successive cohorts will receive escalating doses of HMBD-501 until the RP2D is reached

Primary Outcome Measure

Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse events [ Time Frame: through study completion, an average of 6 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093
HMBD Patients <[email protected]>
Research SiteIndianapolisIndiana46250
HMBD Patients <[email protected]>
Research SiteFarmington HillsMichigan48334
HMBD Patients <[email protected]>
Research SiteDallasTexas75230
HMBD Patients <[email protected]>
Research SiteSan AntonioTexas78229
HMBD Patients <[email protected]>

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