Advanced Solid Tumor Malignancy Clinical Trial
Official title:
Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumor Malignancies
A Phase 1/2a, open-label, dose-escalation study with enrollment in Phase 1 to continue until determination of the Maximum Tolerated Dose (MTD) /Recommended Phase 2a Dose (RP2D), and then enrollment into Phase 2a expansion cohorts will be initiated.
Phase 1 is an open-label, dose-escalation protocol. It is anticipated that up to 36 patients
will be enrolled in Phase 1. All patients will be assigned to treatment with CRLX301 as the
single agent.
For the first 2 cohorts a 1+5 study design will be utilized. A single patient will be
enrolled sequentially into cohort 1 and cohort 2. If either patient in cohort 1 or 2
experiences a dose limiting toxicity (DLT) during Cycle 1, then the cohort will be expanded
to enroll additional patients up to a total of 6.
As of cohort 3 and for all subsequent cohorts, a 3+3 dose escalation schema will be utilized.
MTD/RP2D will be determined at the dose level when <2 of 6 patients experience a DLT in a
cohort.
The Phase 2a part of the study will be an open-label expansion cohort study. An additional 24
patients with advanced, histologically confirmed solid tumor malignancies will be enrolled.
All patients will be assigned to treatment at the MTD/RP2D with CRLX301 as the single agent.
All patients will be followed for safety, tumor response, and progression free survival (PFS)
all per RECIST version 1.1 guidelines. Patients will remain on study treatment until they
experience progression of disease, unacceptable toxicity, or other specified reason for
discontinuation.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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| Active, not recruiting |
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