A Phase I Trial of CRD3874-SI, a STING Agonist, in Patients With Advanced/Metastatic Malignant Solid Tumors
Memorial Sloan Kettering Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female age ≥ 18 years at the time of informed consent. * Be capable, willing, and able to provide written informed consent. * Be willing to comply with clinical trial instructions and requirements, including tumor biopsies (if feasible and required per protocol). * Patients must have a locally advanced or metastatic cancer, a malignant solid tumor that has progressed on at least one line of systemic therapy or for which no standard treatment is available, the participant is intolerant to available treatment, or the participant declined standard of care systemic t…
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
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York