Clinical trial · Interventional
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
A Phase I/II, Open Label, Multicenter Study of the Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 Administered to Patients With Advanced Malignancies
- 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 study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation (phase 1) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion (phase 2) which characterized treatment of LAG525 in combination with PDR001 at the MTD or RP2D.
Conditions
Conditions (1)
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 Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LAG525 | Drug | — | UNRESOLVED |
| PDR001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (29)
- type
- EXPERIMENTAL
- label
- Phase 1: LAG525 1 mg/kg Q2W
- description
- Single-agent LAG525 1 mg/kg Q2W
- interventionNames
- Drug: LAG525
- type
- EXPERIMENTAL
- label
- Phase 1: LAG525 3 mg/kg Q2W
- description
- Single-agent LAG525 3 mg/kg Q2W
- interventionNames
- Drug: LAG525
- type
- EXPERIMENTAL
- label
- Phase 1: LAG525 5 mg/kg Q2W
- description
- Single-agent LAG525 5 mg/kg Q2W
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Phase I part: \- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists Phase II part: * Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression following their last prior therapy and fit into one of the following groups: * Group 1: NSCLC * Group 2: Melanoma * Group 3: Renal cancer * Group 4: Mesothelioma * Group 5: TNBC * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Exclusion Criteria: * History of severe hypersensitivity reactions to study treatment ingredients or other mAbs * Active, known or suspected autoimmune disease * Active infection requiring systemic antibiotic therapy * HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Patients receiving chronic treatment with systemic steroid therapy, other than replacement-dose corticosteroids in the setting of adrenal insufficiency * Patients receiving systemic treatment with any immunosuppressive medication * Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment * Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. * Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks * History of drug-induced pneumonitis or current pneumonitis.
References
Publications (2)
- DERIVEDRivoltini L, Camisaschi C, Fuca G, Paolini B, Vergani B, Beretta V, Damian S, Duca M, Cresta S, Magni M, Leone BE, Castelli C, de Braud F, De Santis F, Di Nicola M. Immunological characterization of a long-lasting response in a patient with metastatic triple-negative breast cancer treated with PD-1 and LAG-3 blockade. Sci Rep. 2024 Feb 9;14(1):3379. doi: 10.1038/s41598-024-54041-9. PMID 38336861
- DERIVEDSchoffski P, Tan DSW, Martin M, Ochoa-de-Olza M, Sarantopoulos J, Carvajal RD, Kyi C, Esaki T, Prawira A, Akerley W, De Braud F, Hui R, Zhang T, Soo RA, Maur M, Weickhardt A, Krauss J, Deschler-Baier B, Lau A, Samant TS, Longmire T, Chowdhury NR, Sabatos-Peyton CA, Patel N, Ramesh R, Hu T, Carion A, Gusenleitner D, Yerramilli-Rao P, Askoxylakis V, Kwak EL, Hong DS. Phase I/II study of the LAG-3 inhibitor ieramilimab (LAG525) +/- anti-PD-1 spartalizumab (PDR001) in patients with advanced malignancies. J Immunother Cancer. 2022 Feb;10(2):e003776. doi: 10.1136/jitc-2021-003776. PMID 35217575