A Study of CRD3874-SI in People With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 therapy.
Disqualifiers
Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene glycol (PEG), (NCI CTCAE v5.0 Grade ≥ 3)
Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
Concurrent opportunistic infection
Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 7 days prior to enrollment. In the setting of non-immune mediated indications for use, chronic/active low dose steroid (equivalent to </=10mg/day prednisone) use may be permitted at the discretion of the principal investigator.
Trial design
Design model
Sequential
Treatments tested in this trial
CRD3874
DrugStarting 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
Treatment groups
81 Participants
are divided into 1 treatment groupGroup A: CRD3874-SIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
maximum tolerated dose (MTD)
The MTD is defined as the highest dose level studied at which \<2 subjects out of 6 experience a DLT. A dose level under consideration as the MTD will be expanded to six patients if only three have been accrued.
Time frame
1 year2
objective response rate (ORR) (Dose expansion)
by RECIST v1.1
Time frame
up to 48 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Curadev Pharma
Collaborator
Source ClinicalTrials.gov