A Study of CRD3874-SI in People With Solid Tumors

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06021626
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Merkel Cell Carcinoma
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CRD3874 — DRUG
    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

Study Details

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.

Key Dates

Start date
Aug 25, 2023
Status verified
Jun 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
81 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CRD3874-SI
    Phase 1a: starting dose of 0.1 mg/kg, Phase 1b: RP2D determined during Phase 1a. Cycle 1 \& 2: once weekly infusion x 4 (Days 1, 8, 15, 22) over 28-day cycle. Cycle 3 onwards: weekly infusion x 3 (Days 1, 8, 15) over 28-day cycle From cycle 3 on wards if a patient is tolerating treatment well and agreeable to continue continuous weekly treatment this will be permitted. The dose expansion phase will explore CRD3874-SI at the RP2D and one additional clinically active dose levels in select solid tumor type. In the dose expansion phase, research blood tests for Peripheral blood mononuclear cells (PBMCs) will be performed before study drug administration on Day 1 of Cycles 1, 2 and 3 and the EOT visit (± 3 days).

Primary Outcome Measure

maximum tolerated dose (MTD) [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Ciara Kelly, MBBCH BAO
[email protected]
646-888-4312
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Ciara Kelly, MBBCH BAO
[email protected]
646-888-4312
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Ciara Kelly, MBBCH BAO
[email protected]
646-888-4312
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Ciara Kelly, MBBCH BAO
[email protected]
646-888-4312
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Ciara Kelly, MBBCH BAO
[email protected]
646-888-4312
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Ciara Kelly, MBBCh BAO
[email protected]
646-888-4312
Ciara Kelly, MBBCh BAO (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Rockville CentreNew York11553
Ciara Kelly, MBBCH BAO
[email protected]
646-888-4312

Find similar trials in Basking Ridge, NJ

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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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