A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers

NCT05337735 | Suspended Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-0589NCI-2022-02841
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

To test the safety of and effectiveness of XmAb20717 for participants with advanced rare cancers.

Conditions

Peritoneal Mesothelioma; Neuroendocrine Carcinomas; Microsatellite High Cancers; Extrapulmonary High Grade; Cervical Carcinoma; Hodgkin's Lymphoma; Pleural Mesothelioma; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To establish the efficacy of XmAb20717 as measured by overall response rate.

  Number of Participants With Objective Radiographic response as Assessed by RECIST v.1.1

  through study completion, an average of 1 year

Study Arms (1)

XmAb20717

EXPERIMENTAL

Participants will receive XmAb20717 by vein over 1 hour on Days 1 and 15 of each cycle.

Drug: XmAb20717

Interventions

XmAb20717 DRUG

Given by vein (IV)

XmAb20717

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is able to complete signed informed consent. Patients for whom English is not their primary language are eligible for participation with translator assistance during the informed consent process.
• Is of age ≥ 18
• Is able, in the investigator's judgment, to comply with the study protocol
• Has measurable disease according to RECIST v1.1 The pleural mesothelioma cohort will require measurable disease according to either modified RECIST or RECIST; the Hodgkin lymphoma patients will be assessed by the 2014 Lugano criteria (see Appendix F)
• Has an ECOG performance status of 0 - 1
• Has adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
• ANC ≥ 1.0×109/L without granulocyte colony-stimulating factor support (for the lymphoma cohort only, Absolute neutrophil count of ≥ 1.0×109/L without growth factor support for 3 days prior to screening assessment.)
• Lymphocyte count ≥ 0.5×109/L
• Platelet count ≥ 100× 109/L without transfusion (for the lymphoma cohort only: platelet count of ≥ 50×109/L without transfusion for 3 days prior to screening assessment)
• Hemoglobin ≥ 90 g/L (for the lymphoma cohort only: Hemoglobin \>80 g/L without transfusion for 3 days prior to screening assessment) (For platelet count and hemoglobin, patients may be transfused to meet either criterion but not within 14 days prior to initiation of study treatment)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5× upper limit of normal (ULN), with the following exceptions:
• Patients with documented liver metastases: AST and ALT ≤ 5×ULN
• Patients with documented liver or bone metastases: ALP ≤ 5×ULN
• Serum bilirubin ≤ 1.5 ×ULN with the following exception:
• Serum creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min OR 24-hour urine creatinine clearance ≥50 mL/min

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from the study:
• Received treatment for the studied cancer within 21 days prior to initiation of study treatment
• Received treatment with targeted therapies or investigational therapies within 21 days or for the duration of 5 half-lives prior to initiation of study treatment
• Has a history of severe allergic, anaphylactic, or other hypersensitivity reactions to study drug
• Has active known- or suspected autoimmune disease (allowed are patients with 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 that requires 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).
• Has a history or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary-, renal-, metabolic-, hematologic-, or psychiatric-) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to patient safety or interfere with study evaluations, procedures, or completion.
• Has had any serious bacterial, viral, parasitic, or systemic fungal infections within 14 days prior to the first dose of study drug.
• Received a live-virus vaccine within 30 days prior to first dose of study drug (vaccines that do not contain live virus are permitted).
• Has another malignancy, except for non-melanoma skin cancer, in situ cervical cancer, or bladder cancer (Tis and T1) that has been adequately treated during the 3 years prior to screening (Note: For MSI-H cohort, prior history of malignancies are allowed unless this may be a competing risk for mortality while on study per the investigator).
• Has untreated or unstable brain metastases. Allowed are those with known brain metastases who have been previously treated and are asymptomatic. If prior local therapy was received, it must have been completed at least 14 days prior to receiving study drug.
• Has evidence of current ILD or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids
• Is breastfeeding or plans to initiate breastfeeding during the study treatment or within 6 months of taking study treatment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Neuroendocrine; Uterine Cervical Neoplasms; Hodgkin Disease; Mesothelioma, Malignant; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Mesothelioma; Adenoma; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Arvind Nageshwara Dasaru, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 20, 2022
• Study Start: August 5, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)