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

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor Malignancy

In brief

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.

Key facts

Study ID

NCT02380677

Run by

NewLink Genetics Corporation

People needed

42

Starts

2015-04-01

Expected to finish

2017-10-04

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥18 years of age
• Diagnosis of histologically or cytologically confirmed, advanced solid tumor malignancy that is refractory to or not a candidate for standard therapy
• ECOG 0 or 1
• Life expectancy >12 weeks
• Fertile males or females of childbearing potential agree to use adequate contraception prior to study entry
• Negative urine pregnancy test

You may not qualify if…

• Uncontrolled grade 2 or greater toxicity except alopecia
• Prolongation of QT/QTc interval
• Women who are pregnant or nursing
• Any known HIV infection or AIDS or any concurrent infection requiring IV antibiotics
• Any chronic or concurrent acute liver disease, including viral hepatitis
• Primary brain malignant tumors
• Known metastases to the brain
• Uncontrolled hypertension
• Concurrent participation in any other investigational study
• Concurrent treatment with anticoagulation medication, unless approved by Sponsor
• History of stroke, deep venous thrombosis (DVT), or transient ischemic attack (TIA)
• History of other cancer type, except for cutaneous basal cell or squamous cell carcinoma, or cervical or prostate cancer in situ, within the last 2 years prior to C1D1
• Uncontrolled concurrent disease or illness
• History of severe hypersensitivity reaction to taxanes
• Peripheral neuropathy exclusions
• Other condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• MD Anderson — Houston, Texas, United States

Full record on ClinicalTrials.gov

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