A Phase 1 Study of IM-1617 in Participants With Advanced Cancer

Part of paid clinical trials in Irving, Texas.

Sponsor
Immunome, Inc.
Study ID
NCT07578571
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • IM-1617 — DRUG
    IM-1617 is an antibody-drug conjugate

Study Details

This study will test the safety and effectiveness of a drug called IM-1617 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have two parts. Part A will test increasing doses of IM-1617 to find out the safe dose and schedule of IM-1617 for participants. Part B will use the dose and schedule found in Part A to further study the safety of IM-1617 and if it works to treat solid tumor cancers.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

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

Arms

  • Experimental: IM-1617 Dose Escalation
    IM-1617 given into the vein (IV; intravenously)
  • Experimental: IM-1617 Monotherapy Dose Expansion
    IM-1617 given into the vein (IV; intravenously)

Primary Outcome Measure

Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Through 30 days after last dose of study treatment; approximately 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NEXT DallasIrvingTexas75039-

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By research site
NEXT Dallas· Irving, TX

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