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

Recruiting
18 years of age
Both
Phase 1

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Overview

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.

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.

Eligibility

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

Study details

Solid Tumors

NCT05996445

Xencor, Inc.

25 January 2024

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