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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunome, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

CRC, all subtypes

Non-squamous cell carcinoma subtypes, such as adenocarcinoma

Squamous cell carcinoma subtype

Disqualifiers

Previously treated with an antibody-drug conjugate (ADC) with a topoisomerase-1 (TOP1) inhibitor payload. Exception: Participants with NSCLC or breast cancer may have received up to one prior ADC with a TOP1 inhibitor payload

History of anaphylactic reaction to TOP1 inhibitors (e.g., irinotecan) or TOP1 inhibiting ADCs

Life expectancy < 12 weeks

Prior solid organ transplant

Trial design

Treatments tested in this trial

  • IM-1617

Treatment groups

175 Participants
are divided into 2 treatment groups

Sponsors and collaborators