A Phase 1, Open-Label, Dose-Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MCLA-145 in Participants With Advanced or Metastatic Malignancies
Recruiting
- Conditions
- melanoma, head and neck squamous cell carcinomaAdvanced or Metastatic Malignancies10025320
- Registration Number
- NL-OMON54744
- Lead Sponsor
- Merus N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
- Participants with melanoma, head and neck squamous cell carcinoma (HNSCC),
urothelial carcinoma, NSCLC, MSI-H/dMMR tumors, or triple negative breast
cancer (TNBC)
- Tumor should histologically or cytologically confirmed
See protocol for more detailed criteria.
Exclusion Criteria
- The following B-cell neoplasms: Burkitt lymphoma, lymphoblastic
leukemia/lymphoma, lymphoplasmacytic lymphoma, chronic lymphocytic leukemia
- Prior therapy containing a 4-1BB agonist or prior therapy with CAR T-cell
therapy.
See protocol for more detailed criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary:<br /><br>Safety and tolerability will be assessed by monitoring the frequency, duration,<br /><br>and severity of AEs. The RDE will be considered a dose that achieves a<br /><br>functional target engagement of PD-L1 and CD-137 based on PK, pharmacodynamic<br /><br>markers, and early signs of clinical activity.</p><br>
- Secondary Outcome Measures
Name Time Method