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A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05996445
Recruitment Status : Recruiting
First Posted : August 18, 2023
Last Update Posted : August 18, 2023
Sponsor:
Information provided by (Responsible Party):
Xencor, Inc.

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 advanced solid tumors and to identify the recommended dose regimen that is safe and biologically effective for XmAb662.

Condition or disease Intervention/treatment Phase
Solid Tumors Biological: XmAb662 Biological: Keytruda® (pembrolizumab) Phase 1

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 of XmAb662 monotherapy or in combination with pembrolizumab in subjects with selected solid tumors that have progressed after standard/approved therapies, or for which there are no effective available therapies. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2), and subdivided into arms for XmAb662 monotherapy and XmAb662+pembrolizumab combination.

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. Characterization of pharmacokinetics [ Time Frame: 56 Days ]
    Measurement of Cmax

  2. Characterization of pharmacokinetics [ Time Frame: 56 Days ]
    Measurement of AUC

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Contacts
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Contact: Benjamin Thompson, MD, PhD 619-517-7381 bthompson@xencor.com
Contact: Ines Hoffmann 619- 994-8161 ihoffmann@xencor.com

Locations
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United States, Virginia
University Of Virginia Comprehensive Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Xencor, Inc.
Investigators
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Study Director: Chet Bohac, MD Executive Medical Director, Clinical Development
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xencor, Inc.:
IL-12,
interleukin-12
pembrolizumab
Advanced Solid Tumors
Metastatic Solid Tumors
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action