Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Tampa, Florida.

Sponsor
Hanmi Pharmaceutical Company Limited
Study ID
NCT06234397
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced or Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

  • BH3120 — DRUG
    BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle
  • pembrolizumab — DRUG
    Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle

Study Details

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.

Key Dates

Start date
Dec 28, 2023
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
245 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BH3120
    Arm A: BH3120 Monotherapy
  • Experimental: BH3120 + pembrolizumab
    Arm B: BH3120 in combination with pembrolizumab

Primary Outcome Measure

Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0. [ Time Frame: Throughout the study until end of safety follow-up period (90 days after the last treatment) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
The START Center for Cancer Care - MidwestGrand RapidsMichigan49546-
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer CenterCincinnatiOhio45219-
Mary Crowley Cancer ResearchDallasTexas75230-
Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer CenterSan AntonioTexas78229-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLThe START Center for Cancer Care - Midwest· Grand Rapids, MICarl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center· Cincinnati, OHMary Crowley Cancer Research· Dallas, TXMays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center· San Antonio, TX

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