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IGM-7354

Phase 1

Solid Tumor | Small molecule | Oncology |IGM Biosciences, Inc.|Last Updated: Jul 24, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05702424Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory CancerPHASE1 COMPLETED 14 — — Jan 10, 2023May 31, 2024Jul 24, 20245 United States
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD
At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)

Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0

Secondary Endpoints
Area Under the Curve (AUC) of IGM-7354
At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Clearance (CL) of IGM-7354
At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Volume of distribution (V) of IGM-7354
At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IGM-7354 Single-Agent Dose EscalationEXPERIMENTALIGM-7354 will be administered intravenously as a single agent.
IGM-7354 Single-Agent Dose Expansion Serial BiopsyEXPERIMENTALIGM-7354 will be administered intravenously as a single agent and patients will undergo pre-treatment and on-treatment biopsies.
Interventions
NameTypeDescription
IGM-7354DRUGIGM-7354 is a PD-L1-targeted cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: * Age \> 18 years at time of signing ICF * ECOG Performance Status of 0 or 1 * Histologic or cytologic documentation of incurable, locally advanced or metastatic solid tumors for which standard therapies are not available, are no longer effective, are not tolerated, or have ...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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