NCT02380677

Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumors

Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumor Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: NewLink Genetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Solid Tumor Malignancy

Interventions

Type	Name	Description
DRUG	CRLX301

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-10-04
• Completion: 2017-10-04
• First posted: 2015-03-05
• Last updated: 2020-06-09
• Results posted: 2020-06-09

Locations

3 sites across 1 country: United States