A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
GigaGen, Inc.
Study ID
NCT06258304
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced or Metastatic Solid Tumor Malignancies

Eligibility Criteria

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

Interventions

  • GIGA-564 — DRUG
    Administered by intravenous infusion
  • GIGA-564 — DRUG
    Administered by intravenous infusion

Study Details

The purpose of this study is to assess the safety and tolerability of GIGA-564 and identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) level(s) of GIGA-564 in participants with metastatic or locally advanced solid tumor malignancies.

Key Dates

Start date
May 8, 2024
Status verified
Apr 2025
Primary completion
Apr 30, 2026
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: GIGA-564: Dose Escalation (Phase 1A)
    Up to 5 dose levels \[0.3, 1.0, 3.0, 10.0, and 20.0 milligrams per kilogram (mg/kg)\] will be evaluated sequentially. Participants will receive GIGA-564 intravenously over at least 60 minutes on Day 1 of every 3 weeks (3 weeks = 1 cycle) for up to 4 cycles until time of confirmed disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
  • Experimental: GIGA-564: Dose Expansion (Phase 1B)
    Dose expansion (Phase 1B) of selected dose levels may be initiated following the preliminary clearance of those specified dose levels from the dose escalation (Phase 1A) as determined by the Sponsor and SRC. Participants will receive up to 4 cycles of one of up to three tolerable dose levels of GIGA-564. GIGA-564 will be given intravenously over at least 60 minutes on Day 1 of every 3 weeks (3 weeks = 1 cycle) for up to 4 cycles until time of confirmed disease progression, unacceptable toxicity, or other reason for treatment discontinuation.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 154 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Cancer InstituteBethesdaMaryland20892-

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By research site
National Cancer Institute· Bethesda, MD