Clinical trial · Interventional
A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies
A Phase 1, Open-Label, Dose-Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MCLA-145 in Participants With Advanced or Metastatic Malignancies
NCT03922204CI-TRIAL-00083579completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, non-randomized, Phase 1 study to determine the safety, tolerability, and preliminary efficacy of MCLA-145 in adult patients with advanced metastatic solid tumors or B-cell lymphomas. The study will be conducted in 2 parts.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| B-cell Lymphoma, Adult | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MCLA-145 | Drug | — | UNRESOLVED |
| Pembrolizumab (Keytruda) | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MCLA-145
- description
- In Part 1, the dose escalation phase, patients with advanced or recurrent/metastatic solid tumors or B-cell lymphomas will receive escalating doses of MCLA-145 (either Q2W for those patients in treatment at the time of Amendment #4 or Q3W with Amendment #4 approval). Treatment will be with MCLA-145 (monotherapy) for Group A, or in combination with pembrolizumab for Group B, until MTD or RDE is reached. In Part 2, the expansion phase, participants with advanced or metastatic solid tumors will receive intravenous infusion of MCLA-145 either in monotherapy (Group A) or in combination with pembrolizumab (Group B) at the recommended phase II dose every 3 weeks. The duration of each treatment cycle is 21 days
- interventionNames
- Drug: MCLA-145
- type
- EXPERIMENTAL
- label
- Group B Combination Treatment
- description
- Patients in Group B will be treated with MCLA-145 in Combination with pembrolizumab 200mg Q3W.
- interventionNames
- Drug: MCLA-145
- Drug: Pembrolizumab (Keytruda)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced or recurrent/metastatic solid tumors or B-cell lymphomas, that are considered non-amenable to surgery or other curative treatments or procedures (if applicable) * Measureable disease per RECIST v1.1 or Lugano Criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Received prior standard therapy for advanced or recurrent/metastatic disease as applicable to tumor type * Received a maximum of 4 prior systemic treatment regimens (inclusive of chemotherapy, immunotherapy, and targeted therapy regimens) for advanced or recurrent/metastatic disease * Life expectancy of ≥12 weeks, as per investigator judgement Exclusion Criteria: * The following B-cell neoplasms: Burkitt lymphoma, lymphoblastic leukemia/lymphoma, lymphoplasmacytic lymphoma, chronic lymphocytic leukemia * Prior therapy containing an anti-PD-L1 agent or T-cell agonist * Current serious illness or medical condition including, but not limited to uncontrolled active infection * Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting MCLA-145 * Prior ≥ Grade 3 immune-mediated AEs with anti-PD-1 therapy * History of any grade immune-mediated ocular AEs. * Known hypersensitivity or severe reaction to any component of MCLA-145 or formulation components * Participants who have active or inactive autoimmune disease or syndrome (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
References
Publications (0)
Data not yet available
No reference posted for this study.