A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers (NCT05337735) | Clinical Trial Compass
SuspendedPhase 2
A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers
Stopped: PI Request
United States140 participantsStarted 2022-08-05
Plain-language summary
To test the safety of and effectiveness of XmAb20717 for participants with advanced rare cancers.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
To establish the efficacy of XmAb20717 as measured by overall response rate.
Timeframe: through study completion, an average of 1 year
✕. 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.
✕. 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.