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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2027
  • participants needed
    242
  • sponsor
    Xencor, Inc.
Updated on 1 October 2020
cancer
combination therapy
estrogen
carcinoma
squamous cell carcinoma
progesterone
pembrolizumab
pd-l1
programmed cell death 1 ligand 1
solid tumors
adenocarcinoma
solid tumour
solid tumor
squamous cell carcinoma of the head and neck
ovarian cancer
hepatocellular carcinoma
progesterone receptor
estrogen receptor
breast carcinoma
fallopian tube
squamous cell carcinoma of head and neck
transitional cell carcinoma
cholangiocarcinoma
ovarian epithelial cancer
adenocarcinoma of prostate
cervical carcinoma
nasopharyngeal carcinoma
head and neck carcinoma
peritoneal cancer
primary peritoneal carcinoma
fallopian tube cancer
xmab22841
lung carcinoma
gastroesophageal junction adenocarcinoma
urothelial carcinoma

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.

Details
Treatment XmAb®22841, Pembrolizumab (Keytruda®)
Clinical Study IdentifierNCT03849469
SponsorXencor, Inc.
Last Modified on1 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: or Brain Function or Kidney Cancer or Gastric or Gastroesophageal Junction Adenocarcinoma or melanoma or Endometrial Cancer or MSI-H or Breast Cancer...?
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 (excluding uveal 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
Microsatellite instability-high or mismatch repair deficient tumors
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

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, and 4P; and within 3 weeks for Cohorts 6M, 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
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