NCT02648711

Alternative Dosing for CRLX101(NLG207) Alone, With Avastin and With mFOLFOX6 in Advanced Solid Tumors

Evaluation of an Alternative Schedule for CRLX101 Alone in Combination With Bevacizumab and in Combination With mFOLFOX6 in Subjects With Advanced Solid Tumor Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: NewLink Genetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of weekly dosing of CRLX101 (both as monotherapy; (Schedule 1) and in combination with bevacizumab every 2 weeks (Schedule 2) and weekly with a 3 week on / 1 week off schedule in combination with mFOLFOX6 (Schedule 3) to affirm the dose for future clinical studies.

Detailed description

This is an open-label, dose escalation study. Subjects enrolled in Schedule 1 will receive weekly CRLX101 alone. The starting dose for Schedule 1 is 12 mg/m\^2 and the next dose level is 15 mg/m\^2 (or 10 mg/m\^2 if 12 mg/m\^2 is not well tolerated). No other dose levels in Schedule 1 will be explored. Subjects enrolled in Schedule 2 will receive weekly CRLX101 in combination with bi-weekly bevacizumab (10 mg/kg) The starting dose for Schedule 2 is 12 mg/m\^ and the next dose is 15 mg/m\^2. No other dose levels in Schedule 2 will be explored Subjects enrolled in Schedule 3 will receive weekly CRLX101 for 3 of every 4 weeks in combination with bi-weekly mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2 and 5FU (fluorouracil) 400 mg/m\^2 bolus followed by 2400 mg/m\^2 continuous infusion). The starting dose for Schedule 3 is 12 mg/m\^2 and the next dose is 15 mg/m\^2. In the absence of dose-limiting toxicities (DLTs) additional subjects may be enrolled (expansion cohort) at the same, intermediate or lower dose levels following consultation between the Investigator and Sponsor. Enrollment of 6-8 subjects will occur in each cohort for all 3 Schedules. The MTD is defined as the highest dose level at which fewer than 2 out of 6 subjects experience a DLT. RP2D will be selected based on overall tolerability data from all subjects treated at different dose cohorts in this study. No intra-patient dose escalation is allowed. Approximately 61 evaluable subjects are anticipated to be enrolled: 15 subjects in Schedule 1, 15 subjects in Schedule 2 and approximately 31 subjects are anticipated in Schedule 3 (approximately 16 in the dose escalation cohort and up to 15 in the expansion cohort). The exact number of subjects is dependent on the actual number of subjects enrolled per cohort and the number of cohorts investigated.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	CRLX101	infusion CRLX101 weekly
DRUG	Bevacizumab	infusion weekly CRLX101 + bevacizumab biweekly
DRUG	mFOLFOX6	infusion weekly CRLX101 for 3 or every 4 weeks and in combination with bi-weekly mFOLFOX6

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-10-17
• Completion: 2018-05-07
• First posted: 2016-01-07
• Last updated: 2020-05-28

Locations

3 sites across 1 country: United States