PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hem… (NCT02730312) | Clinical Trial Compass
CompletedPhase 1
PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
United States120 participantsStarted 2016-08
Plain-language summary
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of 1 of the following diseases:
* Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia)
* B-cell ALL
* BPDCN
* CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor therapy
* Patients with relapsed or refractory disease with no available standard therapy
* ECOG performance status 0-2
* Not a candidate for, or refusing treatment with hematopoietic stem cell transplantation
* Fertile patients must agree to use effective contraception during and for 4 weeks after the last dose of XmAb14045
* Male patients must agree to use highly effective contraception, and refrain from donating sperm during the treatment period and for at least 4 weeks after the last dose of XmAb14045
* Able and willing to complete the entire study
Exclusion Criteria:
* Systemic antineoplastic therapy (including cytotoxic chemotherapy and toxin immunoconjugates, but excluding hydroxyurea), unconjugated antibody therapy, or radiotherapy within 2 weeks of the first dose of study treatment, or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
* Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy
* Failure to recover from Grade 3 or 4 toxicity from previous treatment (unrelated to malignant bone marrow involvement)
* Kn…
What they're measuring
1
Safety as determined by the number of participants with treatment-related adverse events
Timeframe: Baseline Day 1 through Day 56
2
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing