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

NCT05996445 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: XmAb662-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Solid Tumors

Keywords

IL-12,; interleukin-12; pembrolizumab; Advanced Solid Tumors; Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicities (DLTs)

  Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the recommend dose(s)

  First 3 weeks on treatment for each subject]

• Incidence and severity of treatment emergent adverse events (TEAEs)

  Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings

  Up to 2 years

Secondary Outcomes (5)

• Characterization of pharmacokinetics

  56 Days

• Characterization of pharmacokinetics

  56 Days

• Objective response rate

  Up to 2 years

• Progression-free survival

  Up to 2 years

• Duration of response

  Up to 2 years

Study Arms (2)

Dose Escalation and Expansion XmAb662 administered as monotherapy

EXPERIMENTAL

Biological: XmAb662

Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumab

EXPERIMENTAL

Biological: XmAb662; Biological: Keytruda® (pembrolizumab)

Interventions

XmAb662 BIOLOGICAL

Intravenous (IV) administration

Dose Escalation and Expansion XmAb662 administered as monotherapy; Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumab

Keytruda® (pembrolizumab) BIOLOGICAL

Intravenous (IV) administration

Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (3)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University Of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Chet Bohac, MD

  Executive Medical Director, Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignments

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: August 18, 2023
• Study Start: July 28, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (3)