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

NCT02648711 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-05-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • NewLink Genetics Corporation

    lead INDUSTRY

Principal Investigators

  • NewLink Ge · NewLink Genetics Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-10-17
Completion
2018-05-07

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648711 on ClinicalTrials.gov