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Phase 1 Study of IM-1617 for Advanced Cancers

This study is testing a new drug called IM-1617 for people with advanced colorectal, non-small cell lung, breast, esophageal, or stomach cancers that cannot be removed by surgery or have spread. IM-1617 is an antibody-drug conjugate, which means it's designed to deliver a drug directly to cancer cells. The main goal is to find out if IM-1617 is safe and well-tolerated, and to see what dose works best. Researchers will also look at how well IM-1617 treats these cancers. You may be eligible if you are 18 or older, have a good performance status (meaning you can perform daily activities), and have one of the listed cancer types. The study is currently enrolling about 175 participants.

Study design
This is a Phase 1, open-label study with two parts: a dose-escalation phase (Part A) and an expansion phase (Part B). It plans to enroll approximately 175 participants in total.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for about 12 months, specifically for 30 days after your last dose of IM-1617.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07578571

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Immunome, Inc.
~175 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:IM-1617

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Through 30 days after last dose of study treatment; approximately 12 months
+3 more outcomes measured

Conditions

Colorectal Cancer
Non-Small Cell Lung Cancer
Breast Cancer
Esophageal Cancer
Stomach Cancer
Cancer

Explore related trials

Bladder CarcinomaBreast CarcinomaCervical CarcinomaColorectal CarcinomaEsophageal CarcinomaEsophagogastric Junction CancerGastric CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

2 sites across 2 states
Florida1
Texas1

Who to contact

Immunome Medical Monitor
[email protected]
425.939.7410
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
HR+, HER2- subtype
Esophageal, esophagogastric junction, and gastric cancer:
Adenocarcinoma subtype
Other histologies, if approved by the Medical Monitor, which may include: head and neck squamous cell carcinoma; cervical cancer; bladder cancer; squamous cell carcinoma subtype of esophageal, esophagogastric junction, and gastric cancer; HER2+ breast cancer 3. Part B Cohorts - Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
Cohort B1: CRC, all subtypes
Cohort B2: NSCLC
Non-squamous cell carcinoma subtypes, such as adenocarcinoma
Squamous cell carcinoma subtype
Cohorts B3 and B4: Cohort-specific disease indications may include those listed for Part A 4. Participants must have disease that is considered to be noncurative and meet the appropriate criteria below:
Part A only: Participants have progressed on, were intolerant to, or have a contraindication to prior SOC treatments, with no satisfactory SOC treatment options available.
Part B only:
Cohort B1 (CRC):
Participants must have previously progressed on, were intolerant to, or have a contraindication to fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, bevacizumab, and for those with RAS wild-type tumors, an anti-epidermal growth factor receptor (EGFR)-directed monoclonal antibody in advanced disease setting.
Participants with actionable biomarkers must have been treated with at least one prior appropriate biomarker-directed therapy.
If any of these therapies was given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.
Cohort B2 (NSCLC):
Participants must have previously progressed on, were intolerant to, or have a contraindication to platinum-based chemotherapy and a programmed cell death-1 (PD-1)/programmed death ligand 1 (PD-L1) monoclonal antibody (given concurrently or sequentially with chemotherapy) in advanced disease setting.
Participants with actionable biomarkers must have been treated with at least one prior appropriate targeted therapy.
If any of these therapies was given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.
Cohorts B3 and B4: Criteria will be specified based on the disease indications selected. 5. Participants must have measurable disease as defined per RECIST v1.1

What this trial measures

  • 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)Through 30 days after last dose of study treatment; approximately 12 months

    Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0

  • Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of AEs of interest (AEIs)Through 30 days after last dose of study treatment; approximately 12 months

    Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0

  • Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of AEs leading to discontinuationThrough 30 days after last dose of study treatment; approximately 12 months

    Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0

  • Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of deathThrough 30 days after last dose of study treatment; approximately 12 months

    Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0