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CRLX301 in Advanced Solid Tumor Malignancies
NCT02380677Phase 2
Key facts
- Status
- Terminated
- Start
- Apr 2015
- Primary completion
- Oct 2017
- Countries
- 1
- Sponsor
- Lumos Pharma, Inc.
- Modality
- Polymer-based Nanoparticles, Small Molecules
- Drugs
- CRLX301
- Conditions
- malignant solid tumor
01
Overview
Phase 2, open-label trial of CRLX301 in malignant solid tumor (4 cohorts), sponsored by Lumos Pharma, Inc. Primary endpoints: Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities and Number of Phase 2a Participants With Adverse Events at 12 months. Started Apr 2015; status: terminated.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Schedule 1 Cohort 1
CRLX301 7.5 mg/m2 IV Q3W
Schedule 1 Cohort 6
CRLX301 90 mg/m2 IV Q3W
Schedule 2 Cohort 1
CRLX301 25 mg/m2 IV Weekly
Phase 2a expansion cohort
CRLX301 75 mg/m2 IV Q3W
03
Who it enrols
Adult patients with histologically confirmed advanced solid tumor malignancies refractory to standard therapy, with ECOG 0-1 and life expectancy >12 weeks.
04
Endpoints
Primary
Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities
Number of Phase 2a Participants With Adverse Events
Secondary
Pharmacokinetic Profile of CRLX301
Best Overall Tumor Response
Progression-Free Survival
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