A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination with Immune Therapeutic Agents in Adult Subjects with Advanced Solid Tumors
- Conditions
- cancertumour10027476
- Registration Number
- NL-OMON45907
- Lead Sponsor
- Medimmune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
1. Written and signed informed consent and any locally required authorization obtained from the subject/legal representative (where permissible) prior to performing any protocol-related procedures, including screening evaluations.;2. Age * 18 years at the time of study entry.;3.Subjects 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 3 prior lines of systemic therapy for recurrent or metastatic disease (including both standard of care and investigational therapies).;4. Subjects in the dose-escalation phase must have histologic documentation of advanced solid tumors, excluding primary CNS tumors and hematologic malignancies.;5. Subjects in the dose-expansion phase must have recurrent or metastatic disease for the
following tumor types based on treatment arm (see protocol);6. During dose escalation, subjects who have received prior therapy with regimens containing CTLA 4, PD L1, or PD 1 antagonists are permitted to enroll if all of the criteria listed in the protocol are met;7. Subjects must have at least 1 lesion that is measurable using RECIST Version 1.1 guidelines ;8. All subjects are encouraged to consent to and provide both pretreatment and on treatment tumor biopsies. If during dose escalation any dose-level cohort is expanded beyond the initial 3 to 6 subjects, the additional subjects enrolled under pharmacodynamic expansion must consent to and undergo both a pre-treatment and an on treatment tumor biopsy. ;9. ECOG Performance score of 0 or 1, with the exception of the UC cohort where an ECOG
performance score of 2 may be permitted
1. Prior treatment with TNFRSF agonists ;2. History of severe allergic reactions to any unknown allergens or any components of the study drug formulations ;3. Active or prior documented autoimmune disease within the past 2 years. ;4. Concurrent enrollment in another clinical study.;5. Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose of MEDI0562 and durvalumab or tremelimumab combination treatment; in the case of mAbs, 28 days or 5 half lives, whichever is shorter, prior to the first dose of MEDI0562 and durvalumab or tremelimumab combination treatment;6. Any concurrent chemotherapy, IMT, or biologic or hormonal therapy for cancer treatment.;7. Unresolved toxicities from prior anticancer therapy.;8. Systemic therapeutic anticoagulation or daily aspirin dose exceeding 325 mg/per day. ;9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI0562. ;10. History of primary immunodeficiency, solid organ transplantation, or tuberculosis;11. Test results indicating active infection with human immunodeficiency virus (HIV) or hepatitis B or C defined by positive serologic testing and confirmatory viral nucleic acid testing .;12. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products ;13. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of MEDI0562 ;14. Other invasive malignancy within 2 years (exception per protocol);15. Uncontrolled intercurrent illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is safety as assessed by presence of adverse event (AE),<br /><br>serious adverse event (SAE), DLT, abnormal laboratory parameter, vital sign,<br /><br>and electrocardiogram results.</p><br>
- Secondary Outcome Measures
Name Time Method