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IM-1617

Phase 1

Colorectal Cancer | Small molecule | Oncology |Immunome, Inc.|Last Updated: Sep 4, 2026

Target and mechanism

ModalitySmall molecule

Also known as 1617

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment175

FDA Designations

No designations recorded

Clinical trial landscape

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 Sites3

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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Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT07578571lastUpdatePostDate: changed
LOWSep 4, 2026NCT07578571lastUpdatePostDate: changed
LOWJul 9, 2026NCT07578571lastUpdatePostDate: changed
LOWJul 9, 2026NCT07578571lastUpdatePostDate: changed
LOWJun 16, 2026NCT07578571startDate: changed
LOWJun 16, 2026NCT07578571startDate: changed
LOWJun 16, 2026NCT07578571startDate: changed
LOWJun 16, 2026NCT07578571startDate: changed

Frequently asked questions about IM-1617

What is IM-1617 used for?

IM-1617 is an investigational small molecule being studied for the treatment of advanced cancer, including colorectal cancer, non-small cell lung cancer, breast cancer, esophageal cancer, and stomach cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who is developing IM-1617?

IM-1617 is being developed by Immunome, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IMNM. The company is conducting a Phase 1 clinical trial of IM-1617 in participants with advanced cancer.

What phase is IM-1617 in?

IM-1617 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study is currently recruiting participants to evaluate the safety and tolerability of IM-1617 in patients with advanced cancer.

What clinical trials is IM-1617 in?

IM-1617 is being studied in a Phase 1 clinical trial with the identifier NCT07578571. This trial is titled 'A Phase 1 Study of IM-1617 in Participants With Advanced Cancer' and is currently recruiting participants in the United States. The trial is expected to enroll 175 participants.

Is IM-1617 the same as -1617?

Yes, IM-1617 is also known as -1617. Both names refer to the same investigational small molecule drug being developed by Immunome, Inc. for the treatment of advanced cancers, including colorectal cancer.