NCT07578571 · Immunome, Inc.
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
IM-1617
IM-1617 is an antibody-drug conjugate
Primary outcome 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)
Time frame: 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)
Time frame: 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 discontinuation
Time frame: 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 death
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Part A: Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
- CRC, all subtypes
- 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
- 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
- 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.
- Participants must have measurable disease as defined per RECIST v1.1
Exclusion criteria
- 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
- Symptomatic ascites or pleural effusion
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- 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
- Sarasota, Florida
- Irving, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations