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

Completed · Phase 1

Conditions studied: Melanoma, Cervical Carcinoma, Pancreatic Carcinoma, Triple Negative Breast Cancer, Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Renal Cell Carcinoma, Non-small Cell Lung Carcinoma, Small Cell Lung Carcinoma, Gastric or Gastroesophageal Junction Adenocarcinoma, Advanced or Metastatic Solid Tumors, Prostate Carcinoma, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Intrahepatic Cholangiocarcinoma, Squamous Cell Anal Cancer, Squamous Cell Penile Carcinoma, Squamous Cell Vulvar Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma

In brief

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.

Key facts

Study ID

NCT03849469

Run by

Xencor, Inc.

People needed

78

Starts

2019-05-29

Expected to finish

2023-02-16

Last updated by the study team

2023-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UCSD Medical Center - Encinitas — Encinitas, California, United States
• Koman Family Outpatient Pavilion — La Jolla, California, United States
• UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla, California, United States
• UCSD Altman Clinical and Translational Research Institute Building (ACTRI) — La Jolla, California, United States
• UCSD Perlman Medical Offices — La Jolla, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• UCLA Hematology & Oncology Clinic — Los Angeles, California, United States
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States
• UCSD Rancho Bernardo Medical Office — San Diego, California, United States
• UCSD Medical Center - Vista — Vista, California, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Brigham and Women's Health Care Center, Chestnut Hill — Chestnut Hill, Massachusetts, United States
• University of Michigan Medical School — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Karmanos Cancer Institute Weisberg Cancer Treatment Center — Farmington Hills, Michigan, United States
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
• NYU Langone Medical Center (Tisch Hospital) — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Hospital of the University of Pennsylvania - Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• UPMC Shadyside Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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