Status:
TERMINATED
A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
Lead Sponsor:
Xencor, Inc.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous administration of XmAb662 monotherapy or in combination with pembrolizumab in subjects with advan...
Detailed Description
This is a first-in-human (FIH), Phase 1, open-label, multicenter dose escalation study with cohort expansion at one or more recommended dose(s) (RDs), designed to evaluate the safety and tolerability ...
Eligibility Criteria
Inclusion
- Advanced, recurrent or metastatic solid malignancy that is not amenable to curative-intent treatment and which has progressed after standard therapy appropriate for the following tumor type: Head and neck squamous cell carcinoma, melanoma, non-small cell lung cancer, small cell lung cancer (SCLC), urothelial carcinoma, colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial cancer, cutaneous squamous cell carcinoma, breast cancer, ovarian cancer (epithelial), castration-resistant prostate cancer (adenocarcinoma)
- Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- For dose escalation cohorts, subjects must have adequate archival tumor sample or willing to provide a fresh tumor
- Adequate organ function
Exclusion
- Receiving treatment with the following therapies: Interleukin (IL)-12 either alone or as part of a treatment regimen; checkpoint inhibitors given within 4 weeks of study drug; other anticancer therapies, including chemotherapy or radiation therapy, given within 4 weeks of the start of study drug (palliative radiation given within a 1-week washout is allowed)
- History of allergic or anaphylactic/hypersensitivity reaction to immunotherapy
- History of a life-threatening (Grade 4) immune-related adverse event (irAE) related to prior immunotherapy or any prior irAE, regardless of grade
- History or evidence of any clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary malignancy
- Known active central nervous system involvement by malignant disease; subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
- For subjects receiving pembrolizumab, prior Grade 3 or Grade 4 infusion-related reactions to pembrolizumab, or known hypersensitivity to pembrolizumab
- Other protocol defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
July 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05996445
Start Date
July 28 2023
End Date
May 21 2024
Last Update
August 23 2024
Active Locations (3)
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1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
3
University Of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903