This is a Phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess PK and immunogenicity of XmAb18087 monotherapy and in combination with pembrolizumab in subjects with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and XmAb18087 monotherapy in subjects with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies.
Recruiting
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| XmAb18087 | Part A: XmAb18087 Monotherapy | |
| XmAb18087 ± Pembrolizumab | Part B: XmAb18087 + pembrolizumab |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Part A: XmAb18087 Monotherapy | Experimental | Part A, will enroll subjects with previously treated advanced MCC, consists of safety-run in cohorts followed by an expansion cohort. |
|
| Part B: XmAb18087 + pembrolizumab | Experimental | Part B, will enroll subjects with advanced MCC not previously treated with anti-programmed cell death 1 (PD1) or anti-programmed cell death ligand 1 (PDL1) agents, consists of safety run-in cohorts followed by an expansion cohort. |
|
| Part C: XmAb18087 monotherapy | Experimental | Part C will enroll subjects with previously treated extensive-stage SCLC and consists of safety-run in cohorts followed by an expansion cohort. |
|
Inclusion Criteria:
- Able to provide written informed consent
- Adult subjects ≥ 18 years
- Disease measurable by RECIST 1.1 criteria using either computed tomography (CT) or
magnetic resonance imaging (MRI) scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- All subjects must have adequate archival tumor sample (slides or archival
formalin-fixed paraffin-embedded [FFPE] block[s] containing tumor that has not been
previously irradiated
- Female subjects of childbearing potential must agree to use a highly effective method
of birth control during and for 4 weeks after completion of study. success), or sexual
abstinence
- Fertile male subjects must be willing to practice a highly effective method of birth
control for the duration of the study and continuing for 4 weeks after the last dose
of XmAb18087 or pembrolizumab (when applicable
- Able and willing to complete the entire study according to the study schedule
Additional Inclusion Criteria for Part A and Part B Cohorts:
• Histologically or cytologically confirmed metastatic MCC or locoregional MCC that has
recurred following standard locoregional therapy with surgery and/or radiation therapy.
Additional Inclusion Criteria for Part A Cohorts:
• Subjects must have progressed on or been ineligible for treatment with anti-PD1 or
anti-PDL1 therapy.
Additional Inclusion Criteria for Part B Cohorts:
• Subjects must be eligible to receive pembrolizumab as standard of care.
Additional Inclusion Criteria for Part C Cohorts:
: Histologically or cytologically confirmed extensive-stage SCLC that has progressed
following standard therapies
-
Exclusion Criteria:
Additional Exclusion Criteria for Part B Cohorts: XmAb18087 in Combination with
Pembrolizumab In addition to the exclusion criteria in Section 8.6, subjects will be
excluded from Part B safety run-in and expansion cohorts administered XmAb18087 in
combination with pembrolizumab if they meet the following criteria:
- Prior treatment with therapeutics directed at anti-programmed cell death 1 (anti-PD1)
or anti-programmed cell death ligand 1 (anti-PDL1)
- Have severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Incidence of treatment-emergent adverse events (safety), graded by CTCAE version 5.0 |
| Time Frame: | 42 Days |
| Safety Issue: | |
| Description: | Determine the rates of treatment-emergent adverse events as graded by CTAE version 5.0 |
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Xencor, Inc. |
August 5, 2021
