Breast Cancer Clinical Trial

A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

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.

View Eligibility Criteria

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 0-1.

Subjects in monotherapy and combination therapy cohorts must have histologically or cytologically confirmed advanced or metastatic solid tumors, including the following:

Melanoma
Cervical carcinoma
Pancreatic carcinoma
Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (TNBC)
Hepatocellular carcinoma
Urothelial carcinoma
Squamous cell carcinoma of the head and neck (HNSCC)
Nasopharyngeal carcinoma (NPC)
Renal cell carcinoma
Colorectal carcinoma or endometrial carcinoma
Small cell lung carcinoma or NSCLC
Gastric or gastroesophageal junction adenocarcinoma
Prostate adenocarcinoma
Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Intrahepatic cholangiocarcinoma

Subjects in the combination cohorts in Part A with XmAb22841 and pembrolizumab may have an advanced solid tumor that either:

has progressed after treatment with all available therapies that are known to confer clinical benefit, or is intolerant or has refused standard treatment (as for the XmAb22841 monotherapy cohorts), or
is of a tumor type for which pembrolizumab is an approved indication and has not previously been treated with an agent targeting PD1 or PDL1.

PART B (Dose Expansion Cohorts)

XmAb22841 Single Agent Cohort

1. Must have histologically or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with all available therapies that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Eligible tumor types include the following:

Anti-PD1 refractory melanoma (or any uveal melanoma)
Anti-PD1 refractory NSCLC
Anti-PD1 refractory renal cell carcinoma (with clear cell component)
Anti-PD1 refractory urothelial carcinoma
Head and neck squamous cell carcinoma
Hepatocellular carcinoma
Gastric adenocarcinoma
Cervical carcinoma
Breast carcinoma that is estrogen receptor, progesterone receptor, and HER2 negative (TNBC)
Epithelial ovarian cancer
Nasopharyngeal carcinoma
Squamous cell anal carcinoma
Squamous cell penile carcinoma
Squamous cell vulvar carcinoma

XmAb22841 + Pembrolizumab Cohorts

Anti-PD-1 refractory melanoma (excluding uveal melanoma)
Anti-PD-1 naïve melanoma (excluding uveal melanoma)
Anti-PD-1 refractory NSCLC

Anti-PD1 naïve NSCLC

a. Must be PD-L1 high (TPS ≥ 50%), with no EGFR or ALK aberrations

Anti-PD1 naïve urothelial carcinoma

Must be PDL1 positive (CPS of ≥ 10), or ineligible for any platinum-containing chemotherapy regardless of PDL1 status; or
Had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

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 ≤ 1.
Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2.
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.
Participants with known chronic hepatitis B virus (HBV) infection treated for less than 3 months prior to study enrollment and/or with a detectable HBV viral load; or hepatitis C virus (HCV) infection that has been treated for less than 4 weeks prior to study enrollment and/or with a detectable HCV viral load; or active HBV/HCV coinfection.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

242

Study ID:

NCT03849469

Recruitment Status:

Active, not recruiting

Sponsor:

Xencor, Inc.

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There are 23 Locations for this study

See Locations Near You

UCSD Medical Center - Encinitas
Encinitas California, 92024, United States
Koman Family Outpatient Pavilion
La Jolla California, 92037, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla California, 92037, United States
UCSD Altman Clinical and Translational Research Institute Building (ACTRI)
La Jolla California, 92037, United States
UCSD Perlman Medical Offices
La Jolla California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
UCLA Hematology & Oncology Clinic
Los Angeles California, 90095, United States
UC San Diego Medical Center - Hillcrest
San Diego California, 92103, United States
UCSD Rancho Bernardo Medical Office
San Diego California, 92127, United States
UCSD Medical Center - Vista
Vista California, 92081, United States
Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
University of Iowa Hospital and Clinics
Iowa City Iowa, 52242, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Brigham and Women's Health Care Center, Chestnut Hill
Chestnut Hill Massachusetts, 02467, United States
University of Michigan Medical School
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills Michigan, 48334, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States
NYU Langone Medical Center (Tisch Hospital)
New York New York, 10016, United States
Columbia University Medical Center
New York New York, 10032, United States
Hospital of the University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia Pennsylvania, 19104, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
UPMC Shadyside Hospital
Pittsburgh Pennsylvania, 15232, United States
Mary Crowley Cancer Research - Medical City
Dallas Texas, 75230, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

242

Study ID:

NCT03849469

Recruitment Status:

Active, not recruiting

Sponsor:


Xencor, Inc.

How clear is this clinincal trial information?

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