A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Melanoma, Breast Carcinoma, Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Colorectal Carcinoma, Non-small Cell Lung Carcinoma, Gastric or Gastroesophageal Junction Adenocarcinoma, Endometrial Carcinoma, Mesothelioma, Neuroendocrine Carcinoma, Cervical Cancer, Small Cell Lung Carcinoma, Squamous Cell Carcinoma of the Anus, Castration-Resistant Prostate Carcinoma, Nasopharyngeal Carcinoma, Cholangiocarcinoma, Basal Cell Carcinoma, Ovarian Carcinoma, Fallopian Tube Carcinoma, Thymoma, Thymic Carcinoma, Squamous Cell Carcinoma of the Penis, Vulvar Carcinoma, Solid Tumors With Published Evidence of Anti-tumor Activity With Anti-PD1/PDL1 and/or Anti-CTLA4-directed Therapy, Malignant Adnexal Neoplasms, Non-squamous Cell Salivary Gland Carcinoma

In brief

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

Key facts

Study ID

NCT03517488

Run by

Xencor, Inc.

People needed

150

Starts

2018-07-10

Expected to finish

2022-09-06

Last updated by the study team

2022-12-01

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed diagnosis of one of the following advanced solid tumors:
• PART A (Dose Escalation Cohorts)
• Melanoma;
• Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (triple-negative breast cancer; TNBC);
• Hepatocellular carcinoma;
• Urothelial carcinoma;
• Squamous cell carcinoma of the head and neck;
• Renal cell carcinoma (clear cell predominant type);
• Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma;
• Non-small cell lung carcinoma;
• Gastric or gastroesophageal junction adenocarcinoma
• Mesothelioma;
• High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung
• Cervical cancer;
• Squamous cell carcinoma of the anus
• PART B (Dose Expansion Cohorts):
• Melanoma
• Renal cell carcinoma (clear cell predominant type)
• Non-small cell lung carcinoma
• Castrate-resistant adenocarcinoma of the prostate, defined as progressive disease after surgical castration, or progression in the setting of medical androgen ablation with a castrate level of testosterone (< 50 ng/dL)
• Nasopharyngeal carcinoma
• Cholangiocarcinoma
• Basal cell carcinoma
• Squamous cell carcinoma of the anus
• Mesothelioma

You may not qualify if…

• Subjects currently receiving other anticancer therapies, with the exception of subjects with adenocarcinoma of the prostate, who may continue luteinizing hormone-releasing hormone (LHRH) analogue therapy.
• Treatment with any CTLA4 antibody within 6 weeks of the start of study drug.
• Treatment with nivolumab or any PDL1 or PDL2-directed antibody within 4 weeks of the start of study drug.
• Treatment with pembrolizumab within 4 - 12 weeks of the start of study drug (cohort dependent).
• Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.). Subjects with prostate cancer may continue LHRH analogue therapy.
• A life-threatening (Grade 4) immune-mediated AE related to prior immunotherapy.
• Failure to recover from any immune-related toxicity from prior cancer therapy to ≤ Grade 1, except if previous immune-related endocrinopathy is medically managed with hormone replacement therapy only.
• Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2.
• Have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging, are clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
• Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or 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).
• Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted).
• Receipt of an organ allograft.
• Prior treatment with any checkpoint inhibitor therapy regimen that targets both PD1/L1 and CTLA-4.

Where it is running

• Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• UCLA Hematology-Oncology Clinic (Westwood) — Los Angeles, California, United States
• University of California San Diego Moores Cancer Center — San Diego, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• The University of Kansas Clinical Research Center — Fairway, Kansas, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
• Columbia University Medical Center - Herbert Irving Pavilion — New York, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Emily Couric Clinical Cancer Center — Charlottesville, Virginia, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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