Advanced/metastatic solid tumors or lymphomas
Conditions
Interventions
investigational material(s)
Generic name etc : MIW815(ADU-S100)
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational
Sponsors
Novartis K K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent must be obtained prior to any procedures that are not part of standard of care. For Japan only, written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years. Male or female over 18 years. Patients must have measurable disease as determined by RECIST v1.1 (for solid tumors) or Cheson 2014 criteria (for lymphomas). Patients must have at least two sites of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institutions guidelines. / Patient must be willing to undergo new tumor biopsies at screening and during therapy on the study according to the treating institutions own guidelines and requirements for such procedure. Exceptions may be considered after documented discussions with Novartis. Dose escalation/dose confirmation part of study: Patients with advanced/metastatic solid tumors or lymphomas, who have progressed despite standard therapy or are intolerant to standard therapy, for whom no standard therapy exists or for whom standard therapy is notreasonably effective. Dose expansion part of study: Melanoma patients with accessible cutaneous or subcutaneous lesions, who have relapsed or progressed after responding to a PD-1 inhibitor or who are refractory to PD-1 inhibitors. Dose expansion will also include patients with accessible cutaneous or subcutaneous lesions with HNSCC or patients with other accessible cutaneous or subcutaneous solid tumors and lymphomas, who have progressed despite standard therapy or are intolerant of standard therapy, for whom no standard therapy exists or for whom standard therapy is not reasonably effective. In addition, patients with injectable visceral lesions who have MSS CRC or other solid tumors with accessible visceral lesions, who have progressed despite standard therapy or are intolerant of standard therapy, for whom no standard therapy exists or for whom standard therapy is not reasonably effective. Eastern Cooperative Oncology Group (ECOG) Performance Status under 1.
Exclusion criteria
Exclusion criteria: Patients who require immediate local palliative measures such as radiotherapy (XRT) or surgery. History of severe hypersensitivity reactions to any ingredient of study drug(s) and other monoclonal antibodies and/or their excipients Active, known or suspected autoimmune disease or a documented history of autoimmune disease History of or current drug-induced interstitial lung disease or pneumonitis over grade2. Patients who discontinued prior anti-PD-1 therapy due to an anti-PD-1-related toxicity. Patients who required discontinuation of study treatment due to treatmentrelated toxicities with prior therapy directed against the same target as the drug(s) under study in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety To characterize safety and tolerability of MIW815 (ADU-S100) given with PDR001 and identify recommended doses and schedule for future studies | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics pharmacodynamics To evaluate the preliminary anti-tumor activity of the combination of MIW815 (ADU-S100) with PDR001 To characterize the PK of MIW815 (ADU-S100) and PDR001 To assess PD effects in injected and distal tumor lesions | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed