CClinicalTrials.gg
Sign In
RecruitingNCT07578571Updated Sep 29, 2026

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

A Phase 1 interventional study of IM-1617 in Colorectal Cancer, Non-Small Cell Lung Cancer and Breast Cancer, sponsored by Immunome, Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Immunome, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
175
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

This is a Phase 1 open-label, multicenter, dose escalation and expansion study designed to determine the safety, tolerability, PK, and preliminary antitumor activity of IM-1617 administered to participants with unresectable locally advanced or metastatic solid tumors. The study consists of 2 parts:

Part A: A dose-escalation phase to evaluate the safety and tolerability of IM-1617 to determine the recommended dose for expansion (RDE), evaluate maximum tolerated dose, and maximum achievable dose of IM-1617 in up to approximately 75 participants.

Part B: An expansion phase to further evaluate the safety and preliminary antitumor activity of IM-1617 monotherapy at the RDE and one or more other dose regimens in up to 4 indication-specific cohorts. Up to approximately 100 participants will be enrolled in Part B.

02

Conditions studied

  • Colorectal Cancer
  • Non-Small Cell Lung Cancer
  • Breast Cancer
  • Esophageal Cancer
  • Stomach Cancer
  • Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  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
      • 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

Exclusion criteria

Exclusion Criteria:

  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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
175 participants (estimated)

Study arms

  • Experimental
    IM-1617 Dose Escalation

    IM-1617 given into the vein (IV; intravenously)

    Drug: IM-1617

  • Experimental
    IM-1617 Monotherapy Dose Expansion

    IM-1617 given into the vein (IV; intravenously)

    Drug: IM-1617

Interventions

  • DrugIM-1617

    IM-1617 is an antibody-drug conjugate

05

What researchers measure

Primary outcomes

  1. 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)

    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

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  2. 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)

    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

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  3. 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

    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

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  4. Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of death

    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

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

Secondary outcomes

  1. Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by area under the concentration-time curve (AUC)

    Pharmacokinetic (PK) parameter

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  2. Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by maximum observed concentration (Cmax)

    PK parameter

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  3. Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by time to maximum observed concentration (Tmax)

    PK parameter

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  4. Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by trough concentration (Ctrough)

    PK parameter

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  5. Characterize the immunogenicity of IM-1617

    Incidence of antidrug antibodies (ADA)

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  6. Evaluate the preliminary antitumor activity of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors

    Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator

    Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months

  7. Evaluate the preliminary antitumor activity of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors

    Complete Response Rate (CRR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator

    Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months

  8. Evaluate the preliminary antitumor activity of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors

    Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator

    Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months

06

Study locations

4 of 4 sites recruiting
  • Yale Cancer Center
    New Haven, Connecticut 06520, United States
    Recruiting
  • Florida Cancer Specialists & Research Institute - Sarasota Cattlemen
    Sarasota, Florida 34239, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
  • NEXT Dallas
    Irving, Texas 75039, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07578571
Lead sponsor
Immunome, Inc.
Responsible party
Sponsor
First posted
May 11, 2026
Start date
May 21, 2026
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Sep 29, 2026

Study contacts

Immunome Medical Monitor
Contact
info@immunome.com
800-811-4074

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colorectal Neoplasms→

Other studies from this sponsor

Immunome, Inc.

Start the discussion