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

NCT07578571 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IM-1617-101
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

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

• 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

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

• 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

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

• 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

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

Secondary Outcomes (8)

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

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

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

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

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

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

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

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

• Characterize the immunogenicity of IM-1617

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

Study Arms (2)

IM-1617 Dose Escalation

EXPERIMENTAL

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

Drug: IM-1617

IM-1617 Monotherapy Dose Expansion

EXPERIMENTAL

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

Drug: IM-1617

Interventions

IM-1617 DRUG

IM-1617 is an antibody-drug conjugate

IM-1617 Dose Escalation; IM-1617 Monotherapy Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immunome, Inc.: lead

Study Sites (1)

NEXT Dallas

Irving, Texas, 75039, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases

Central Study Contacts

Immunome Medical Monitor

CONTACT

425.939.7410; IM-1617-101@immunome.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)