Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgki… (NCT04853329) | Clinical Trial Compass
TerminatedPhase 1
Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma
Stopped: Business reasons
United States7 participantsStarted 2021-12-13
Plain-language summary
This first-in-human Phase 1 study will be a multicenter, dose-escalating, single-agent study conducted in patients with advanced CD20-associated hematological cancers for which the investigator determines there to be no other higher priority therapies available.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
The following key inclusion criteria apply to both Part A and Part B:
* Diagnosis of CD20 positive NHL. CD20 assay to have been performed within 6 months prior to protocol entry. Eligible NHL subtypes include Diffuse Large B-Cell Lymphoma (DLBCL, not otherwise specified, NOS), Follicular Lymphoma, Chronic lymphocytic leukemia/small lymphocytic lymphoma, B cell prolymphocytic leukemia and Mantle cell lymphoma.
* Patients with SLL must have received, or not be eligible for, BTK and BCL-2 inhibitor therapy.
* Disease progression or relapse following at least two prior lines of conventional systemic therapy for advanced disease. Dosing regimen must have included a CD20 targeted therapy (for example, RCHOP).
* A clinical indication for treatment must be present for patients with Follicular Lymphoma and Chronic/Small/Prolymphocytic/Mantle B-cell non-Hodgkin lymphoma.
* Having at least one measurable target lesion present and documented by RECIST 1.1.
* Adequate organ function, such as Renal function, Hepatic Function, Cardiovascular, Adequate hematological reserve.
* Complete resolution of all prior toxicities from prior anticancer therapy, defined as having resolved to baseline or to common terminology criteria for adverse events (CTCAE) grade≤1, with the exception of alopecia, or to the levels dictated in the inclusion/exclusion criteria, and a washout period of 5 half-lives of prior small molecule systemic therapy.
* Life expectancy \>12 weeks.
* Age: Lower…
What they're measuring
1
To determine the recommended single-agent CPO107 RP2D
Timeframe: through study completion, an average of 1 year