Actively Recruiting
A Study of CRD3874-SI in People With Solid Tumors
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-29
81
Participants Needed
7
Research Sites
309 weeks
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
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.
CONDITIONS
Official 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 65 18 years at the time of informed consent.
- Able and willing to provide written informed consent.
- Willing to follow clinical trial instructions and requirements, including tumor biopsies if feasible.
- Have locally advanced or metastatic malignant solid tumor that progressed after at least one line of systemic therapy or no standard treatment is available, intolerant to available treatment, or declined standard systemic therapy.
- Eligible tumor types include head and neck squamous cell carcinoma, adenoid cystic carcinoma, Merkel cell carcinoma, sarcoma subtypes responsive to immune checkpoint blockade, melanoma including uveal, mucosal, acral, and non-small cell lung cancer.
- For head and neck squamous cell carcinoma, must have recurrent/metastatic disease with 1-2 prior systemic therapies including checkpoint inhibitor and specific HPV/PD-L1 status.
- For adenoid cystic carcinoma, may have received 0-2 prior systemic therapies.
- For Merkel cell carcinoma, must have 1-3 prior systemic therapies including checkpoint inhibitor and no prior chemotherapy for MCC.
- For uveal melanoma, must have 1-2 prior systemic therapies including tebentafusp if HLA-A 02:01+ or immune checkpoint inhibitor.
- For mucosal and acral melanoma, must have 1-2 prior systemic therapies including prior immune checkpoint inhibition; BRAF-MEK therapy allowed up to 3 prior lines.
- For non-small cell lung cancer, must have prior immune checkpoint inhibition and 1-2 prior systemic therapies.
- Adequate performance status: ECOG 0 or 1/KPS 100-70%.
- Life expectancy of at least three months after first CRD3874 infusion.
- Presence of measurable disease per RECIST v1.1; target lesions not from previously irradiated fields unless progression documented.
- Agree to pretreatment and on-treatment tumor biopsies for research or provide archival tissue if biopsy not feasible.
- Female participants of childbearing potential must have negative pregnancy test prior to first dose.
- Adequate organ function within 14 days of treatment initiation as defined by specified blood counts, liver and kidney function, coagulation tests, and heart function.
You will not qualify if you...
- Known severe hypersensitivity to study drug components including polyethylene glycol.
- Clinically significant immunosuppression including primary immunodeficiency, opportunistic infection, or systemic immunosuppressive therapy (>2 weeks or prednisone >10 mg/day) within 7 days prior to enrollment.
- Prior organ transplantation or allogenic stem-cell transplantation; autologous transplant allowed if >5 years post-transplant.
- History or evidence of symptomatic or active autoimmune disease requiring systemic treatment in past 2 years.
- Systemic antibiotics within 7 days before first study dose.
- Uncontrolled medical conditions including active infection requiring therapy or symptomatic congestive heart failure within 6 months.
- Inability to follow protocol required procedures.
- Resting QTc interval ≥470 ms on ECG.
- Participation in another investigational study with treatment within 4 weeks or 5 half-lives.
- Recent chemotherapy, monoclonal antibody therapy, or radiation therapy within specified timeframes before first dose.
- Clinically significant interstitial lung disease or active pneumonitis related to prior immunotherapy.
- Unstable or worsening cardiovascular disease within 6 months.
- Known active central nervous system metastases or carcinomatous meningitis unless stable and off steroids.
- Live vaccine within 30 days before starting study drug except inactivated seasonal influenza vaccine.
- Active hepatitis B or C infection not controlled or untreated.
- Uncontrolled HIV infection.
- Pregnant or breastfeeding women.
- Expecting to conceive or father children during study and specified follow-up periods.
- Unwillingness to use effective contraception during and after study treatment.
- Concurrent active malignancy that could interfere with study.
- History of non-infectious colitis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Sandra D'Angelo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here