patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusion
Conditions
Interventions
Sponsors
Moizumi Sanae
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female patients must be >= 18 years of age. 3. Dose escalation part: patients with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma or other solid tumors. Patients with solid tumors other than mesothelioma must have local available data for loss-of-function NF2/LATS1/LATS2 genetic alterations (truncating mutation or gene deletion; LATS1/LATS2 mutations will only be included in the dose escalation part), or functional YAP/TAZ fusions. Patients with malignant EHE can be enrolled with only histological confirmation of the disease. Patients must have failed available standard therapies, be intolerant of or ineligible for standard therapy, or for whom no standard therapy exists. 4. Dose expansion part: the following patients will be enrolled into 3 different treatment groups: Group 1: Advanced (unresectable or metastatic) MPM patients who have failed available standard therapies for advanced/metastatic disease, be intolerant or ineligible to receive such therapy, or for whom no standard therapy exists. Group 2: Advanced (unresectable or metastatic) solid tumor patients with available local data for NF2 truncating mutation or deletions. Patient must have failed available standard therapies, be intolerant or ineligible to receive such therapy, or for whom no standard therapy exists. Group 3: Advanced (unresectable or metastatic) solid tumor patients with available local data for functional YAP/TAZ fusions. EHE patients can be included with only histological confirmation of the disease. Patient must have failed available standard therapies, be intolerant or ineligible to receive such therapy, or for whom no standard therapy exists. 5. Presence of at least one measurable lesion according to mRECIST v1.1 for mesothelioma patients, RECIST v1.1 for patients with other solid tumors, or RANO for patients with primary brain tumors. 6. Patient must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening/baseline, and again during therapy on this study.
Exclusion criteria
Exclusion criteria: 1. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes: a. == Grade 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of patients with adverse events and serious adverse events [ Time Frame: 3 years ] Safety and tolerability of IAG933 2. Incidence of dose limiting toxicities during the first treatment cycle (dose escalation only) [ Time Frame: 1 year ] Safety, tolerability and the maximum tolerated dose or recommended dose of IAG933 3. Number of patients with dose interruptions and dose changes [ Time Frame: 3 years ] Tolerability of IAG933 | — |
Countries
Australia, Japan, Spain
Contacts
Public ContactSanae Moizumi
Novartis Pharma. K.K.
Outcome results
None listed