Recent Updates
Recently added Catalysts

-1617

Phase 1

Colorectal Cancer | Small molecule | Oncology |Immunome, Inc.|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment175
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07578571A Phase 1 Study of IM-1617 in Participants With Advanced CancerPHASE1 RECRUITING 175May 1, 2026Jan 1, 2029May 22, 20261 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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
Unlock Eligibility Criteria
Competitive Landscape -Colorectal Cancer 263 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV8PHASE3Telisotuzumab Adizutecan, Telisotuzumab adizutecan, Bevacizumab, Trifluridine/Tipiracil, ABBV-400
Bristol-Myers Squibb CompanyBMY7PHASE3Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan
Merck & Co., Inc.MRK6PHASE3Pembrolizumab, Oxaliplatin, Leucovorin, 5-fluorouracil, Irinotecan
Johnson & JohnsonJNJ5PHASE3Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Oxaliplatin
Pfizer Inc.PFE12PHASE3PF-08634404, Bevacizumab, Chemotherapy, tucatinib, trastuzumab
GSK plc Sponsored ADRGSK6PHASE3Dostarlimab, CAPEOX, FOLFOX, GSK4418959, PD-1 inhibitor
Exelixis, Inc.EXEL5PHASE3XL092, Atezolizumab, Regorafenib, cabozantinib, atezolizumab
Summit Therapeutics IncSMMT3PHASE3Drug: Ivonescimab, Drug: Bevacizumab, AK112, AK117, Oxaliplatin
Natera, Inc.NTRA4PHASE3Capecitabine, Oxaliplatin, Folfirinox, FOLFOX regimen
Agenus Inc.AGEN4PHASE3Balstilimab, Botensilimab, CR6086, AGEN2034
Incyte CorporationINCY2PHASE3INCA33890, Bevacizumab, FOLFOX, Ruxolitinib, Capecitabine
Amgen Inc.AMGN1PHASE3FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb
Eli Lilly and CompanyLLY8PHASE2LY2157299, Capecitabine, Fluorouracil, LY4066434., Cetuximab
AstraZeneca PLCAZN8PHASE2Datopotamab deruxtecan, Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE2fruquintinib, FOLFIRI, oxaliplatin , levofolinate calcium , 5-FU, panitumumab, mFOLFOX6 + panitumumab combination therapy
Novartis AG Sponsored ADRNVS7PHASE2Dabrafenib, Trametinib, JDQ443, TNO155, tislelizumab
BioNTech SE Sponsored ADRBNTX3PHASE2RO7198457, PM8002, Chemotherapy Regimen 1, BNT314, BNT327
Regeneron Pharmaceuticals, Inc.REGN2PHASE2Cemiplimab + Fianlimab, VV1, Cemiplimab
Revolution Medicines, Inc.RVMD7PHASE1RMC-6291, Elironrasib, Daraxonrasib, RMC-9805, RMC-6236
Veracyte, Inc.VCYT1PHASE3Tislelizumab
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07578571Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07578571studyFirstPostDate: changed
LOWMay 21, 2026NCT07578571NEW_TRIAL: changed
LOWMay 21, 2026NCT07578571NEW_TRIAL: changed