A Study of XmAb®20717 in Subjects With… | Clinical Trial

Key information

Conditions

Melanoma Adenocarcinoma Adenoma Adnexal Diseases Anus Diseases Anus Neoplasms Basal Cell Carcinoma Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Breast Carcinoma Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Basal Cell Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell Castration-Resistant Prostate Carcinoma Cervical Cancer Cholangiocarcinoma Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Carcinoma Endometrial Neoplasms Fallopian Tube Carcinoma Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric or Gastroesophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Hemic and Lymphatic Diseases Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Lymphatic Diseases Male Urogenital Diseases Malignant Adnexal Neoplasms Mesothelioma Mouth Diseases Mouth Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Complex and Mixed Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Carcinoma Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Carcinoma Non-squamous Cell Salivary Gland Carcinoma Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Penile Diseases Penile Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Solid Tumors With Published Evidence of Anti-tumor Activity With Anti-PD1/PDL1 and/or Anti-CTLA4-directed Therapy Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of the Anus Squamous Cell Carcinoma of the Head and Neck Squamous Cell Carcinoma of the Penis Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Thoracic Neoplasms Thymic Carcinoma Thymoma Thymus Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vulvar Carcinoma Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
Ovarian or fallopian tube carcinoma
Malignant adnexal neoplasms (including, but not limited to, sebaceous carcinoma, trichilemmal carcinoma, pilomatrix carcinoma, eccrine carcinoma, hidradenocarcinoma, adnexal carcinoma with divergent differentiation, papillary digital eccrine adenocarcinoma, microcystic adnexal carcinoma, and clear cell eccrine carcinoma)
Thymoma
Thymic carcinoma
Squamous cell carcinoma of the penis
Neuroendocrine carcinoma
Vulvar cancer
Non-squamous cell salivary gland carcinoma (except adenoid cystic carcinoma)
Subjects with other solid tumors for which there is published evidence of anti-tumor activity with anti-PD1/PDL1 and/or anti-CTLA4-directed therapy but for which there is no FDA-approved anti-PD1/PDL1 or CTLA4-directed checkpoint inhibitor treatment may be eligible for Part B after approval by the Medical Monitor.

All subjects' cancer must have progressed after treatment with all standard therapies or have no appropriate available therapies.
Subjects, except those with adenocarcinoma of the prostate, must have measurable disease by RECIST 1.1.
Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue
ECOG performance status of 0 - 1
Subjects with adenocarcinoma of the prostate must have evaluable disease (measurable or nonmeasurable lesions) by PCWG3.

Exclusion criteria

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.

Treatment and study plan

XmAb20717

Biological

Monoclonal bispecific antibody

Primary outcomes

Determine the safety and tolerability profile of XmAb20717

Time frame: 56 Days

Treatment-related adverse events as assessed by CTCAE v4.03

Sponsors and collaborators

Lead sponsor

Xencor, Inc.

Industry

Collaborators

ICON plc

Registry information

Official study title

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

Acronym: DUET-2

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: May 7, 2018
Registry last updated: Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed