Advanced Solid Tumor Malignancy Clinical Trial
Official title:
Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumor Malignancies
Verified date | May 2020 |
Source | Lumos Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 42 |
Est. completion date | October 4, 2017 |
Est. primary completion date | October 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Male or female =18 years of age 2. Diagnosis of histologically or cytologically confirmed, advanced solid tumor malignancy that is refractory to or not a candidate for standard therapy 3. ECOG 0 or 1 4. Life expectancy >12 weeks 5. Fertile males or females of childbearing potential agree to use adequate contraception prior to study entry 6. Negative urine pregnancy test Exclusion Criteria: 1. Uncontrolled grade 2 or greater toxicity except alopecia 2. Prolongation of QT/QTc interval 3. Women who are pregnant or nursing 4. Any known HIV infection or AIDS or any concurrent infection requiring IV antibiotics 5. Any chronic or concurrent acute liver disease, including viral hepatitis 6. Primary brain malignant tumors 7. Known metastases to the brain 8. Uncontrolled hypertension 9. Concurrent participation in any other investigational study 10. Concurrent treatment with anticoagulation medication, unless approved by Sponsor 11. History of stroke, deep venous thrombosis (DVT), or transient ischemic attack (TIA) 12. 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 13. Uncontrolled concurrent disease or illness 14. History of severe hypersensitivity reaction to taxanes 15. Peripheral neuropathy exclusions 16. 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | MD Anderson | Houston | Texas |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
NewLink Genetics Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities | Determination of MTD is dependent upon number of dose limiting toxicities and significant adverse events observed. | 13 to 19 months | |
Primary | Number of Phase 2a Participants With Adverse Events as a Measure of Safety and Tolerability | Safety variables will include AEs, SAEs, Severe AEs, Related AEs and AEs leading to Discontinuation in phase 2a subjects. | 12 months | |
Secondary | Evaluate the Pharmacokinetic (PK) Profile of CRLX301 | Area under the concentration vs time curve of released docetaxel in blood and/or urine specimens of patients receiving at least 1 dose of CRLX301. | 2.5 years | |
Secondary | Percentage of Participants Stratified by Best Overall Tumor Response | Best overall tumor response will be provided per dose cohort using RECIST 1.1 | 2.5 years |
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