Actively Recruiting
A Phase I Trial of CRD3874-SI, a STING Agonist, in Patients With Advanced or Metastatic Malignant Solid Tumors
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-05
81
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
C
Curadev Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a study drug called CRD3874-SI in adults with advanced or metastatic malignant solid tumors, including types such as sarcoma, Merkel Cell Carcinoma, head and neck squamous cell carcinoma, adenoid cystic carcinoma, uveal melanoma, mucosal and acral melanoma, and non-small cell lung cancer. The study aims to find the highest dose of CRD3874-SI that causes only mild or manageable side effects and to learn more about how the drug is processed by the body and how the immune system responds to it. Participants receive weekly intravenous infusions of CRD3874-SI starting at a dose of 0.1 mg/kg, with dose levels increasing in phases to find the recommended dose for further study. The treatment cycles vary, with the first two cycles consisting of four weekly infusions each over 28 days, and later cycles providing three weekly infusions if the treatment is well tolerated. The trial also includes a dose expansion phase where the recommended dose and one additional active dose are tested in selected tumor types. Blood tests and tumor biopsies are performed during the study to help assess the drug's effects. During the trial, participants undergo regular evaluations including tumor biopsies (when feasible), blood tests for immune cells, and assessments of tumor response. Safety is closely monitored through side effect tracking and organ function tests. The study's main outcomes include determining the maximum tolerated dose over one year and measuring tumor response rates during dose expansion up to 48 weeks. Participation may last several months depending on treatment tolerance and disease progression, with ongoing monitoring to understand the drug's safety and activity.
CONDITIONS
Brief Title
A Study of CRD3874-SI in People With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 18 years or older at the time of consent
- Able and willing to provide written informed consent
- Willing to comply with trial instructions, including tumor biopsies if required
- Have locally advanced or metastatic malignant solid tumor progressed on at least one systemic therapy or have no standard treatment available, or are intolerant to or declined standard therapy
- Specific tumor types eligible in dose escalation phase: head and neck squamous cell carcinoma, adenoid cystic carcinoma, Merkel cell carcinoma, sarcoma, melanoma (uveal, mucosal, acral), and non-small cell lung cancer
- Adequate performance status (ECOG 0 or 1; KPS 100-70%)
- Life expectancy of at least three months after first infusion
- Measurable disease per RECIST v1.1, not from previously irradiated field unless progression documented
- Agree to pretreatment and on-treatment tumor biopsies for research in dose expansion phase, with exceptions if biopsy not feasible or high risk
- Female participants of childbearing potential must have negative pregnancy test before first dose
- Adequate organ function within 14 days of treatment start, including blood counts, liver and kidney function, coagulation, and heart function
You will not qualify if you...
- Severe hypersensitivity to investigational product or components including polyethylene glycol
- Clinically significant immunosuppression or primary immunodeficiency
- Systemic immunosuppressive therapy above specified doses or durations
- Prior organ transplantation except certain autologous transplants with conditions
- Active or recent autoimmune disease requiring systemic treatment
- Recent systemic antibiotics use exceeding 7 days prior to first dose
- Uncontrolled medical conditions or active infections compromising safety
- Inability to comply with protocol procedures
- Prolonged QTc interval over 470 ms on ECG
- Recent participation in other investigational agent studies within specified timeframes
- Recent chemotherapy, targeted therapy, monoclonal antibody, or radiation therapy without recovery
- Clinically significant interstitial lung disease or pneumonitis related to prior immunotherapy
- Unstable or deteriorating cardiovascular disease in prior 6 months
- Active central nervous system metastases or carcinomatous meningitis unless stable
- Live vaccine within 30 days before study drug start (certain flu vaccines allowed)
- Active Hepatitis B or C infections except controlled cases
- Uncontrolled HIV infection with specific criteria for eligibility
- Pregnant or breastfeeding women
- Expecting to conceive or father children during study and specified post-treatment periods
- Unwillingness to use effective contraception methods
- Concurrent active malignancy interfering with study
- History of non-infectious colitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive weekly intravenous infusions of CRD3874-SI in 28-day cycles, with dose escalation and potential continuous treatment if tolerated.
Weekly visits for infusions during each 28-day cycle
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
C
Ciara Kelly, MBBChBAO
S
Sandra D'Angelo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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