A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
- Conditions
- Solid Tumors
- Registration Number
- NCT05996445
- Lead Sponsor
- Xencor, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria:<br><br>Advanced, recurrent or metastatic solid malignancy that is not amenable to<br>curative-intent treatment and which has progressed after standard therapy appropriate for<br>the following tumor type: Head and neck squamous cell carcinoma, melanoma, non-small cell<br>lung cancer, small cell lung cancer (SCLC), urothelial carcinoma, colorectal cancer,<br>gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell<br>carcinoma, renal cell carcinoma, endometrial cancer, cutaneous squamous cell carcinoma,<br>breast cancer, ovarian cancer (epithelial), castration-resistant prostate cancer<br>(adenocarcinoma)<br><br>Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable<br>disease according to PCWG3 criteria may enroll<br><br>Life expectancy of at least 3 months<br><br>Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2<br><br>For dose escalation cohorts, subjects must have adequate archival tumor sample or willing<br>to provide a fresh tumor<br><br>Adequate organ function<br><br>Exclusion Criteria:<br><br>Receiving treatment with the following therapies: Interleukin (IL)-12 either alone or as<br>part of a treatment regimen; checkpoint inhibitors given within 4 weeks of study drug;<br>other anticancer therapies, including chemotherapy or radiation therapy, given within 4<br>weeks of the start of study drug (palliative radiation given within a 1-week washout is<br>allowed)<br><br>History of allergic or anaphylactic/hypersensitivity reaction to immunotherapy<br><br>History of a life-threatening (Grade 4) immune-related adverse event (irAE) related to<br>prior immunotherapy or any prior irAE, regardless of grade<br><br>History or evidence of any clinically unstable/uncontrolled disorder, condition, or<br>disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic,<br>or psychiatric) other than their primary malignancy<br><br>Known active central nervous system involvement by malignant disease; subjects with<br>previously treated brain metastases may participate provided they are radiologically and<br>clinically stable<br><br>For subjects receiving pembrolizumab, prior Grade 3 or Grade 4 infusion-related reactions<br>to pembrolizumab, or known hypersensitivity to pembrolizumab<br><br>Other protocol defined inclusion/exclusion criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs);Incidence and severity of treatment emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method Characterization of pharmacokinetics;Characterization of pharmacokinetics;Objective response rate;Progression-free survival;Duration of response