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IGM-7354

Phase 1

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

IGM-7354 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2023

IGM-7354 target and mechanism

Molecular targetPD-L1
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

IGM-7354 clinical trials

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 10 trials (matched to "Solid Tumor")

Frequently asked questions about IGM-7354

What is IGM-7354 used for?

IGM-7354 is an investigational therapy being studied for the treatment of solid tumors. It is being developed for adults with relapsed and/or refractory cancer, meaning disease that has returned or has not responded to prior treatment. It has not been approved for any use and remains in clinical development.

What does IGM-7354 target?

IGM-7354 targets PD-L1, a protein that tumors use to suppress immune responses. By binding PD-L1, the drug is designed to interfere with that immune-evasion pathway in solid tumors. IGM-7354 is a small molecule directed at PD-L1 and is being evaluated in oncology.

Who is developing IGM-7354?

IGM-7354 is being developed by IGM Biosciences, Inc., which trades on the Nasdaq under the ticker IGMS. The company is the sponsor of the clinical program evaluating the agent in patients with relapsed and/or refractory solid tumors.

What phase is IGM-7354 in?

IGM-7354 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The Phase 1 program has been conducted in adults with relapsed and/or refractory cancer.

What clinical trials is IGM-7354 in?

IGM-7354 has been evaluated in one Phase 1 clinical trial, NCT05702424, titled Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer. That study enrolled 14 participants with solid tumors in the United States and is listed as completed. It was a controlled study that enrolled adults aged 18 years and older.