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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
NewLink Genetics Corporation
Study ID
NCT02648711
Phase
PHASE1
Status
Terminated

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 7, 2016
Start date
Oct 31, 2015
Status verified
May 2020
Primary completion
Oct 17, 2017
Completion
May 7, 2018

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CRLX101 alone
    Subjects will receive weekly infusion of CRLX101 alone. Starting dose 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 will be explored.
  • Experimental: CRLX101 in combination with bevacizumab
    Subjects receive weekly infusion of CRLX101 in combination with bi-weekly bevacizumab (10 mg/kg. The starting dose is 12 mg/m\^2 and the next dose level is 15 mg/m\^2. No other dose levels will be explored.
  • Experimental: CRLX101 in combination with mFOLFOX6
    Subjects receive weekly infusion of 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 400 mg/m\^2 bolus followed by 2400 mg/m\^2 continuous infusion). The starting dose is 12 mg/m\^2 and the next dose level is 15 mg/m\^2.

Primary Outcome Measure

Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) [ Time Frame: 15 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
START Midwest/Cancer & Hematology Centers of Western Michigan, PCGrand RapidsMichigan49503-
MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics (START), LLCSan AntonioTexas78229-

Find similar trials in Grand Rapids, MI

By research site
START Midwest/Cancer & Hematology Centers of Western Michigan, PC· Grand Rapids, MIMD Anderson Cancer Center· Houston, TXSouth Texas Accelerated Research Therapeutics (START), LLC· San Antonio, TX

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