A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-Expressing Hematologic Malignancies
Overview
- Phase
- Phase 1
- Intervention
- XmAb13676
- Conditions
- B-cell Non-Hodgkins Lymphoma
- Sponsor
- Xencor, Inc.
- Enrollment
- 154
- Locations
- 23
- Primary Endpoint
- Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to provide written informed consent
- •Diagnosis of either Non-CLL B cell malignancy
- •Ineligible for or have exhausted standard therapeutic options and have relapsed or refractory disease
- •ECOG performance status 0-2
- •Fertile patients must agree to use highly effective contraception during and for 5 months (male patients) and 8 months (female patients) after last dose of XmAb13676
- •Able and willing to complete the entire study
- •Additional Patient Inclusion Criteria for the DLBCL Cohort (Expansion Phase)
- •Histologically confirmed diagnosis (specified by 2016 World Health Organization) of DLBCL or transformed low-grade lymphoma with measurable disease
- •Patient must be refractory or have relapsed after 2 or more standard therapeutic options, at least one of which must have included anti-CD20 antibody therapy.
- •Not a candidate for or refusing treatment with hematopoietic stem cell transplantation
Exclusion Criteria
- •Cytotoxic chemotherapy, radiotherapy, or immunotherapy including other anti-CD20 antibodies within 4 weeks, or small molecule or investigational agents within 5 elimination half-lives of the first dose of XmAb13676
- •Prior solid organ transplantation
- •Failure to recover from Grade 3 or 4 toxicity from previous treatment
- •Multiple myeloma/plasma cell leukemia or B cell acute lymphoblastic leukemia
- •Known intolerance to CD20 monoclonal antibody therapy
- •History of primary central nervous system lymphoma or neoplastic central nervous system disease
- •Platelet count \< 50 x 10\^9/L
- •Absolute neutrophil count \< 1.0 x 10\^9/L
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at screening \> 3x upper limit of normal (ULN)
- •Bilirubin \> 1.5 mg/dL unless prior diagnosis and documentation of ongoing hemolysis or Gilbert's syndrome has been made)
Arms & Interventions
Non-CLL B Cell Malignancies (Group NHL) Part A
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Intervention: XmAb13676
CLL/SLL (Group CLL) Part A
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Intervention: XmAb13676
Non-CLL B Cell Malignancies (Group NHL) Part B
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Intervention: XmAb13676
CLL/SLL (Group CLL) Part B
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Intervention: XmAb13676
Non-CLL B Cell Malignancies (Group NHL) Part C / Expansion
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Intervention: XmAb13676
Non-CLL B Cell Malignancies (Group NHL) Part D / Expansion
XmAb13676 administered SC up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Intervention: XmAb13676
Outcomes
Primary Outcomes
Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame: Baseline Day 1 through Day 56
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing
Time Frame: Baseline Day 1 through Day 56