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About
To test the safety of and effectiveness of XmAb20717 for participants with advanced rare cancers.
Full description
Primary Objective:
Efficacy of XmAb20717 as defined by objective response (defined as a complete response [CR] or partial response [PR] on two consecutive occasions ≥4 weeks apart) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)
Secondary Objectives:
Exploratory Objective
To identify biomarkers that are predictive of response and/or are associated with progression to a more severe disease state (i.e., prognostic biomarkers).
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Study Participant Inclusion Criteria
Inclusion Criteria:
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:
Must agree to use a highly effective method of birth control (as defined in Section 7.4.1) (female patients and male patients with female partners of childbearing potential) during and for 6 months after last dose of study treatment. Also see related information in Section 6.6.10.8.
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Basket-specific Inclusion Criteria:
Peritoneal Mesothelioma: Has advanced MPeM that was previously treated with and refractory/intolerant to platinum-pemetrexed systemic chemotherapy or has not received treatment and is ineligible for platinum-pemetrexed treatment
Pleural Mesothelioma: Has unresectable MPM and is treatment naïve or has received any line of prior therapy, including anti-PD1/anti-PDL1/anti-CTLA4.
High-grade Neuroendocrine Carcinoma: Has extra-pulmonary site carcinoma (small-cell- and large-cell lung cancer excluded) and has received therapy with a platinum-based chemotherapy regimen
MSI-H Cancers: Has not had anti-PD1 / anti-PDL1 / anti-CLTA4 therapyMSI-H/dMMR, locally advanced or metastatic solid tumors. Locally advanced solid tumors are defined by having ≥20% chance of recurrence with surgery alone. Patients with localized solid tumors are also eligible if they have a high risk for surgical mortality defined as >5% by ACS National Surgery Quality Improvement Program. Patients being treated with neoadjuvant intent may be treated for up to 6 months prior to surgical resection, though in patients with clear clinical benefit as deemed by treating physicians, a non-operative approach-treatment duration ≥ 6 months (and up to 2 years)-may be considered.
Note: ASC = American College of Surgeons, MSI-H = microsatellite instability-high, dMMR = deficient mismatch repair.
Lymphoma: Has relapsed, refractory classical Hodgkin lymphoma and has received first-line chemotherapy. Prior treatment with anti-PD1 / PDL1 antibody is not exclusionary.
Cervical Cancer: Has recurrent, metastatic, or persistent cervical cancer (squamous cell carcinoma, adenosquamous, or adenocarcinoma of the cervix) and has received at least one prior line of systemic therapy and not amenable to curative treatment. Prior treatment with anti-PD1 / PDL1 antibody is not exclusionary.
Small-cell lung cancer: Extensive-stage small-cell lung cancer following treatment with prior platinum-based therapy, which can include prior anti-PD1, anti-PDL1, but not anti-CTLA4.
Study Participant Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from the study:
Primary purpose
Allocation
Interventional model
Masking
140 participants in 1 patient group
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Central trial contact
Arvind Nageshwara Dasari, MD
Data sourced from clinicaltrials.gov
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