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IM-1617

Phase 1

Colorectal Cancer | Small molecule | Oncology |Immunome, Inc.|Trials Updated: Sep 29, 2026

IM-1617 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment175

FDA Designations

No designations recorded

IM-1617 clinical trials

IM-1617 · 1 trial · 6 indications

Phase 1 1
NCT07578571A Phase 1 Study of IM-1617 in Participants With Advanced CancerColorectal Cancer
RECRUITING175 Analytics
PHASE1RECRUITING
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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 discontinuation
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
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

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IM-1617 Dose EscalationEXPERIMENTALIM-1617 given into the vein (IV; intravenously)
IM-1617 Monotherapy Dose ExpansionEXPERIMENTALIM-1617 given into the vein (IV; intravenously)

Interventions

NameTypeDescription
IM-1617DRUGIM-1617 is an antibody-drug conjugate
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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, suc...

Countries:United States
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Competitive Landscape -Colorectal Cancer 363 trials

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Recent Changes (Last 90 Days)

LOWSep 29, 2026NCT07578571lastUpdatePostDate: changed
LOWSep 29, 2026NCT07578571lastUpdatePostDate: changed
LOWSep 17, 2026NCT07578571lastUpdatePostDate: changed
LOWSep 17, 2026NCT07578571lastUpdatePostDate: changed
LOWSep 4, 2026NCT07578571lastUpdatePostDate: changed
LOWSep 4, 2026NCT07578571lastUpdatePostDate: changed

Frequently asked questions about IM-1617

What is IM-1617?

IM-1617 is an investigational small molecule being developed by Immunome, Inc. for the treatment of advanced solid tumors, including colorectal cancer. It is a biomarker-selected therapy, meaning trial enrollment is guided by a specific molecular marker. IM-1617 is currently in Phase 1 clinical development and has not been approved by the FDA.

What is IM-1617 used for in colorectal cancer?

IM-1617 is being studied for use in colorectal cancer as part of a Phase 1 trial in participants with advanced cancer. The study also enrolls patients with non-small cell lung cancer, breast cancer, esophageal cancer, stomach cancer, and other cancers. IM-1617 is investigational and has not been approved for any indication.

Who makes IM-1617?

IM-1617 is being developed by Immunome, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol IMNM. Immunome is the sponsor of the ongoing Phase 1 study of IM-1617 in advanced solid tumors.

What phase is IM-1617 in?

IM-1617 is in Phase 1 clinical development. The only registered trial of IM-1617 is a Phase 1 study that is currently recruiting participants. IM-1617 is investigational and has not received FDA approval.

What clinical trials is IM-1617 in?

IM-1617 is being evaluated in one clinical trial, NCT07578571, titled A Phase 1 Study of IM-1617 in Participants With Advanced Cancer. The trial is recruiting, is controlled, is not randomized or double-blind, and plans to enroll 175 participants aged 18 years and older in the United States.

Is IM-1617 the same as 1617?

Yes, 1617 is an alternative name for IM-1617, the investigational small molecule developed by Immunome, Inc. Both names refer to the same Phase 1 asset being studied in advanced solid tumors, including colorectal cancer, under the trial identifier NCT07578571.