Study of safety and tolerability of MIW815 (ADU-S100) in combination with
- Conditions
- Advanced/metastatic solid tumors or lymphomas
- Registration Number
- JPRN-jRCT2080223739
- Lead Sponsor
- ovartis K K
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 9
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>To characterize safety and tolerability of MIW815 (ADU-S100) given with PDR001<br>and identify recommended doses and schedule for future studies
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>pharmacodynamics<br>To evaluate the preliminary anti-tumor activity of the combination of MIW815<br>(ADU-S100) with PDR001<br>To characterize the PK of MIW815 (ADU-S100) and PDR001<br>To assess PD effects in injected and distal tumor lesions