A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®22841 Monotherapy and in Combination With Pembrolizumab in Subjects With Selected Advanced Solid Tumors (DUET-4)

Xencor, Inc.28 sites in 1 country78 target enrollmentMay 29, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Melanoma
Sponsor: Xencor, Inc.
Enrollment: 78
Locations: 28
Primary Endpoint: Safety and tolerability profile of XmAb22841 assessed by rates of treatment-related adverse events (AEs), graded by CTCAE v4.03.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of XmAb22841 monotherapy and in combination with pembrolizumab in subjects with select advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

May 29, 2019

End Date

February 16, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Xencor, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•PART A (Dose Escalation Cohorts)
•All subjects' cancer must have progressed after treatment with all available therapies that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment.
•All subjects must have adequate archival tumor, or give consent to a fresh tumor biopsy.
•Subjects have an ECOG performance status of 0-
•Subjects in monotherapy and combination therapy cohorts must have histologically or cytologically confirmed advanced or metastatic solid tumors, including the following:
•Cervical carcinoma
•Pancreatic carcinoma
•Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (TNBC)
•Hepatocellular carcinoma
•Urothelial carcinoma

Exclusion Criteria

•Prior treatment with an investigational anti-LAG3 therapy.
•Treatment with any CTLA4 antibody within 16 weeks of the start of study drug for Cohorts 1M, 2M, 3M, 1P, and 2P; within 8 weeks for Cohorts 4M, 5M, 3P, 4P and 4Pi; and within 3 weeks for Cohorts 6M, 7Mi, 7M, 5P, and 6P.
•Systemic antineoplastic therapy, unconjugated antibody therapy within 4 weeks of the first dose of study treatment; or radiotherapy within 2 weeks of the first dose of study treatment; or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
•Have received prior therapy with an anti-PD1, anti-PDL1, or anti PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA4, OX 40, CD137) AND were permanently discontinued from that treatment due to an irAE.
•Failure to recover from any irAE from prior cancer therapy to Grade ≤
•Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤
•Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs).
•Receipt of an organ allograft.
•Treatment with antibiotics within 14 days prior to first dose of study drug.
•Participants with known HIV.