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IGM-7354

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

IGM-7354 · 1 trial · 1 indication

Phase 1 1
NCT05702424Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory CancerSolid Tumor
COMPLETED14 Analytics
PHASE1COMPLETED
Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer
Solid TumorUnlock trial analytics

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 to 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 (matched to "Solid Tumor")

Frequently asked questions about IGM-7354

What is IGM-7354 used for in solid tumors?

IGM-7354 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, having been evaluated in a completed trial for adults with relapsed and/or refractory cancer. The drug is not yet approved and remains under investigation.

Who makes IGM-7354?

IGM-7354 is being developed by IGM Biosciences, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol IGMS. IGM Biosciences is responsible for the clinical development of this investigational oncology drug.

What phase is IGM-7354 in?

IGM-7354 is in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the drug in adults with relapsed and/or refractory solid tumors. The drug is investigational and has not received regulatory approval.

What clinical trials is IGM-7354 in?

IGM-7354 has been studied in a Phase 1 clinical trial with the identifier NCT05702424, titled 'Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer.' This trial enrolled 14 participants with solid tumors in the United States and has been completed.

Is IGM-7354 FDA approved?

IGM-7354 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in solid tumors. The drug remains in clinical development and has not been authorized for commercial use.