Status:
COMPLETED
A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
Lead Sponsor:
MedImmune LLC
Conditions:
Recurrent or Metastatic Solid Tumors
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with recurrent or metastatic solid tumors.
Detailed Description
This is a Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and antitumor activity o...
Eligibility Criteria
Inclusion
- Male and female subjects; age ≥ 18
- Written informed consent must be obtained
- Subjects must meet the following criteria:
- Have recurrent or metastatic solid tumors
- Must have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor type. Subjects should not have received more than 5 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies
- Subjects must have at least 1 lesion
- Subjects must consent to provide archived tumor specimens and / or tumor biopsy for correlative biomarker studies.
- Eastern Cooperative Oncology Group performance score of 0 or 1
- In the opinion of the invesgator likely to complete ≥ 8 weeks of treatment.
- Adequate organ function as determined by:
- i. Absolute neutrophil count ≥ 1.5 x 109/L (1,500/mm3) ii.Platelet count ≥ 100 x 109/L (100,000/mm3) iii.Hemoglobin ≥ 9.0 g/dL within first 2 weeks prior to first dose of investigational product iv.Calculated creatinine clearance\* (CrCl) or 24 hour urine CrCl \> 50 mL/min v.Total bilirubin ≤ 1.5× ULN; for subjects with documented/suspected Gilbert's disease, bilirubin ≤ 3× ULN vi.Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5× ULN vii.Serum Electrolytes within normal limits
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of highly effective contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product; 10) Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through 90 days after receipt of the final dose of investigational product
Exclusion
- Prior treatment with TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR) .
- Subjects who have received prior therapy with regimens containing CTLA-4, PDL-1, or PD-1 antagonists are NOT permitted to enroll unless all of the following apply:
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
- All AEs while receiving prior immunotherapy must have resolved to ≤ Grade 1 or baseline prior to screening for this study.
- Must not have experienced a ≥ Grade 3 AE or neurologic or ocular AE of any grade while receiving prior immunotherapy
- History of severe allergic reactions to any unknown allergens or any components of the study drug formulations
- Active or prior documented autoimmune disease within the past 2 years.
- Untreated central nervous system metastatic disease l
- Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study
- Receipt of anticancer therapy within 28 days prior to the first dose of Investigational Product
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- Unresolved toxicities from prior anticancer therapy
- Systemic anticoagulation or daily aspirin dose exceeding 325 mg per day
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI6383. )
- History of primary immunodeficiency, solid organ transplantation, or tuberculosis
- True positive test results for human immunodeficiency virus (HIV) or hepatitis B or C
- Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products )
- Pregnant or breastfeeding women
- Major surgery (as defined by the investigator) within 4 weeks prior to first dose of MEDI6383 or still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable
- Other invasive malignancy within 2 years
- \-
Key Trial Info
Start Date :
September 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2017
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02221960
Start Date
September 15 2014
End Date
July 3 2017
Last Update
March 13 2019
Active Locations (8)
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1
Research Site
La Jolla, California, United States, 92093
2
Research Site
New Haven, Connecticut, United States, 06520
3
Research Site
Washington D.C., District of Columbia, United States, 20007
4
Research Site
Chicago, Illinois, United States, 60611