RecruitingPhase 1NCT06021626

A Study of CRD3874-SI in People With Solid Tumors

A Phase I Trial of CRD3874-SI, a STING Agonist, in Patients With Advanced/Metastatic Malignant Solid Tumors


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

81 participants

Start Date

Aug 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study will test the safety of a study drug called CRD3874-SI. The researchers will test different doses of CRD3874-SI to find the highest dose that causes few or mild side effects in participants. After the researchers find the highest safe dose of CRD3874-SI, they will test that dose in new groups of participants to help them learn more about the side effects of the study drug and find out whether CRD3874-SI is an effective treatment for for patients with advanced or metastatic malignant solid tumors including sarcoma and Merkel Cell Carcinoma. (MCC), Head and neck squamous cell carcinoma (HNSCC), Adenoid cycstic carcinoma (ACC), Uveal Melanoma, Muscosal and Acral melanoma, and Non small cell lung cancer. The researchers will also look at how the body absorbs, distributes, and gets rid of CRD3874-SI, and the how the body and immune system respond to CRD3874-SI.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial tests CRD3874-SI, a new experimental drug, in people with advanced solid tumors (various cancer types) that have not responded to standard treatments, with a focus on understanding safe doses and initial effectiveness. **You may be eligible if...** - You are 18 or older with a locally advanced or metastatic solid tumor that has progressed on at least one prior standard therapy - You are in reasonably good health (ECOG 0–1) with a life expectancy of at least 3 months - Your tumor has measurable disease - In the expansion phase: you have specific tumor types including sarcomas (UPS/MFS, angiosarcoma, bone sarcoma) or Merkel cell carcinoma that has progressed on prior immunotherapy **You may NOT be eligible if...** - You have had major surgery, active infection, or certain cardiovascular events recently - You are pregnant, breastfeeding, or not using contraception - You have significant kidney, liver, or bone marrow dysfunction - You are allergic to any component of the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCRD3874

Starting dose is 0.1 mg/kg for weekly IV infusion of CRD3874-SI. Cohort CRD3874-SI Dose level (mg/kg) 1. 0.1 2. 0.3 3. 0.9 4. 1.8 5. 2.7 6. 4.05


Locations(7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06021626


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