Actively Recruiting
A Phase 1 Study of IM-1617 in Participants With Advanced Malignancies
Led by Immunome, Inc. · Updated on 2026-05-22
175
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IM-1617, a drug being studied for safety and how well it works in people with advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body. This Phase 1 study includes participants with various types of advanced cancers, including colorectal, non-small cell lung, breast, esophageal, and stomach cancers. The trial aims to find the safest dose and understand how the drug behaves in the body while assessing its potential effects on tumors. The trial has two parts: Part A tests increasing doses of IM-1617 given through a vein to determine the safe dose and schedule for future use, enrolling about 75 participants. Part B uses the dose from Part A to study the drug's safety and tumor-fighting activity in up to four specific cancer groups, with up to 100 participants. Both parts deliver IM-1617 intravenously and focus on monitoring safety and preliminary effectiveness. Participants will receive regular safety checks for adverse events and blood tests to study how the drug moves through the body and its immune effects for up to about 12 months after the last dose. Researchers will use tumor scans and disease progression assessments to measure the drug's impact. Safety monitoring continues for 30 days after treatment ends, and participants may have follow-up visits to track outcomes and side effects throughout the study period.
CONDITIONS
Brief Title
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Histological diagnosis of unresectable locally advanced or metastatic solid tumors, including colorectal cancer (all subtypes), non-small cell lung cancer (non-squamous and squamous cell carcinoma), breast cancer (triple-negative and HR+, HER2- subtypes), esophageal, esophagogastric junction, and gastric cancer (adenocarcinoma subtype), or other approved histologies
- For Part B cohorts, diagnosis of specific unresectable or metastatic solid tumors as defined for each cohort
- Disease considered noncurative and prior progression on, intolerance to, or contraindication to standard treatments as specified for Part A and Part B cohorts
- Measurable disease as defined per RECIST v1.1
You will not qualify if you...
- Prior treatment with an antibody-drug conjugate (ADC) containing a topoisomerase-1 (TOP1) inhibitor payload, except up to one prior ADC with TOP1 inhibitor payload in NSCLC or breast cancer
- History of anaphylactic reaction to TOP1 inhibitors or TOP1 inhibiting ADCs
- Life expectancy less than 12 weeks
- Prior solid organ transplant
- Symptomatic ascites or pleural effusion
- Known active central nervous system metastases or carcinomatous meningitis
- History of another primary solid or blood cancer (except the cancer under study) unless in remission for at least 2 years and approved by Medical Monitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 months or until disease progression or discontinuation
Participants receive IM-1617, an antibody-drug conjugate, intravenously to evaluate its safety, tolerability, and preliminary antitumor activity.
Visits occur regularly during treatment to monitor safety and response
Duration - Approximately 30 days after last dose
Participants are monitored for safety and antitumor activity for up to 30 days after the last dose of IM-1617.
1 to 2 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
Research Team
I
Immunome Medical Monitor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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