"Ph1: •Locally advanced (LA) or metastatic MTAP-deleted (met.MTAP-del.) solid tumors •MTAP-del.relapsed or refrac. Grade 4 astrocytoma or glioblastoma multiforme (R/R GBM) Ph2: A1:LA or met.MTAP-del. squamous and nonsquamous NSCLC A2:LA or met.MTAP-del. mesothelioma A3:LA or met.MTAP-del. sarcoma A4:LA or met.MTAP-del. pancreatic ductal adenocarcinoma or adenosquamous carcinoma w/predominantly adenocarcinoma histology A5:Other LA or met.MTAP-del. solid tumors A6:MTAP-del. R/R GBM"
Conditions
Brief summary
Phase 1: Incidence of DLTs within the first 28 days of treatment with TNG908 monotherapy Phase 2: - ORR (CR + PR) as determined by RECIST v1.1, mRECIST v1.1, or modified RANO criteria per investigator assessment - DOR as determined by RECIST v1.1, mRECIST v1.1, or modified RANO criteria per investigator assessment, - PFS by investigator assessment - CBR (CR + PR + stable disease) at 16 weeks
Detailed description
"Secondary – Phases 1 and 2 - Type, frequency, severity, timing, and relationship to study treatment of any AEs, SAEs, and changes in vital signs, ECGs, ECOG performance status or Karnofsky performance status, and safety laboratory tests - PK parameters of TNG908 including, but not limited to, Cmax, Tmax, AUC0-t, AUC0-∞, t1/2, λz, CL/F, Vz/F, Rac for Cmax and AUC, and Ctrough - Changes in SDMA levels in tumor after dosing with TNG908 "
Interventions
DRUGTNG908
DRUGMIDAZOLAM
Sponsors
Tango Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Incidence of DLTs within the first 28 days of treatment with TNG908 monotherapy Phase 2: - ORR (CR + PR) as determined by RECIST v1.1, mRECIST v1.1, or modified RANO criteria per investigator assessment - DOR as determined by RECIST v1.1, mRECIST v1.1, or modified RANO criteria per investigator assessment, - PFS by investigator assessment - CBR (CR + PR + stable disease) at 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| "Secondary – Phases 1 and 2 - Type, frequency, severity, timing, and relationship to study treatment of any AEs, SAEs, and changes in vital signs, ECGs, ECOG performance status or Karnofsky performance status, and safety laboratory tests - PK parameters of TNG908 including, but not limited to, Cmax, Tmax, AUC0-t, AUC0-∞, t1/2, λz, CL/F, Vz/F, Rac for Cmax and AUC, and Ctrough - Changes in SDMA levels in tumor after dosing with TNG908 " | — |
Countries
France
Outcome results
None listed