A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT05996445 |
Recruitment Status :
Recruiting
First Posted : August 18, 2023
Last Update Posted : August 18, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors | Biological: XmAb662 Biological: Keytruda® (pembrolizumab) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 210 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Sequential Assignments |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors |
Actual Study Start Date : | July 28, 2023 |
Estimated Primary Completion Date : | September 30, 2028 |
Estimated Study Completion Date : | September 30, 2030 |
Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation and Expansion XmAb662 administered as monotherapy |
Biological: XmAb662
Intravenous (IV) administration |
Experimental: Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumbab |
Biological: XmAb662
Intravenous (IV) administration Biological: Keytruda® (pembrolizumab) Intravenous (IV) administration |
- Incidence of dose-limiting toxicities (DLTs) [ Time Frame: First 3 weeks on treatment for each subject] ]Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the recommend dose(s)
- Incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings
- Characterization of pharmacokinetics [ Time Frame: 56 Days ]Measurement of Cmax
- Characterization of pharmacokinetics [ Time Frame: 56 Days ]Measurement of AUC
- Objective response rate [ Time Frame: Up to 2 years ]Objective response rate by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer
- Progression-free survival [ Time Frame: Up to 2 years ]Progression-free survival by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer
- Duration of response [ Time Frame: Up to 2 years ]Duration of response by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05996445
Contact: Benjamin Thompson, MD, PhD | 619-517-7381 | bthompson@xencor.com | |
Contact: Ines Hoffmann | 619- 994-8161 | ihoffmann@xencor.com |
United States, Virginia | |
University Of Virginia Comprehensive Cancer Center | Recruiting |
Charlottesville, Virginia, United States, 22903 |
Study Director: | Chet Bohac, MD | Executive Medical Director, Clinical Development |
Responsible Party: | Xencor, Inc. |
ClinicalTrials.gov Identifier: | NCT05996445 |
Other Study ID Numbers: |
XmAb662-01 |
First Posted: | August 18, 2023 Key Record Dates |
Last Update Posted: | August 18, 2023 |
Last Verified: | August 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
IL-12, interleukin-12 pembrolizumab Advanced Solid Tumors Metastatic Solid Tumors |
Neoplasms Pembrolizumab Antineoplastic Agents, Immunological |
Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |