A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Immunome, Inc.
You may qualify if…
- ✓ 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- ✓ 2. Part A: Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
- ✓ CRC, all subtypes
- ✓ NSCLC:
- ✓ Non-squamous cell carcinoma subtypes, such as adenocarcinoma
- ✓ Squamous cell carcinoma subtype
- ✓ Breast cancer (subtypes based on estrogen/progesterone receptor and HER2 testing according to American Society of Clinical Oncology - College of American Pathologists guidelines):
- ✓ Triple-negative breast cancer
You may not qualify if…
- ✕ 1. 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
- ✕ 2. History of anaphylactic reaction to TOP1 inhibitors (e.g., irinotecan) or TOP1 inhibiting ADCs
- ✕ 3. Life expectancy \< 12 weeks
- ✕ 4. Prior solid organ transplant
- ✕ 5. Symptomatic ascites or pleural effusion
- ✕ 6. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- ✕ 7. Known history of another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of recurrence for at least 2 years and approved by the Medical Monitor
Where it's recruiting
Source: ClinicalTrials.gov · NCT07578571 · last updated 2026-07-09