MTAP-deleted Advanced or Metastatic Solid Tumors
Conditions
Brief summary
Phase 1: • Incidence of DLTs within the first 28 days of treatment with TNG462 as a single agent • Incidence of DLTs within the first 21 days of treatment with TNG462 plus pembrolizumab Phase 2: • ORR (CR + PR) as determined by RECIST v1.1, mRECIST v1.1, or iRECIST per investigator assessment • DOR as determined by RECIST v1.1, mRECIST v1.1 or iRECIST per investigator assessment • PFS by investigator assessment • CBR (CR + PR + stable disease) at 16 weeks
Detailed description
Phase 1: • ORR (CR + PR) as determined by RECIST v1.1, mRECIST v1.1 or iRECIST, per investigator assessment • DOR as determined by RECIST v1.1, mRECIST v1.1 or iRECIST,per investigator assessment • PFS by investigator assessment • CBR (CR + PR + stable disease) at 16 weeks for patients treated with single agent or at 18 weeks for patients treated with the pembrolizumab combination, Phase 1 and 2: Type, frequency, severity, timing, and relationship to study treatment of any AEs, SAEs, and changes in vital signs, ECGs, and safety laboratory tests PK parameters of TNG462 Pre-treatment and trough pembrolizumab concentrations Changes in SDMA levels in tumor after dosing with TNG462
Interventions
DRUGTNG462
DRUGBUCCOLAM 10 mg oromucosal solution
DRUGBUCCOLAM 5 mg oromucosal solution
DRUGBUCCOLAM 7.5 mg oromucosal solution
DRUGPEMBROLIZUMAB
Sponsors
Tango Therapeutics Inc., 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 TNG462 as a single agent • Incidence of DLTs within the first 21 days of treatment with TNG462 plus pembrolizumab Phase 2: • ORR (CR + PR) as determined by RECIST v1.1, mRECIST v1.1, or iRECIST per investigator assessment • DOR as determined by RECIST v1.1, mRECIST v1.1 or iRECIST per investigator assessment • PFS by investigator assessment • CBR (CR + PR + stable disease) at 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: • ORR (CR + PR) as determined by RECIST v1.1, mRECIST v1.1 or iRECIST, per investigator assessment • DOR as determined by RECIST v1.1, mRECIST v1.1 or iRECIST,per investigator assessment • PFS by investigator assessment • CBR (CR + PR + stable disease) at 16 weeks for patients treated with single agent or at 18 weeks for patients treated with the pembrolizumab combination, Phase 1 and 2: Type, frequency, severity, timing, and relationship to study treatment of any AEs, SAEs, and changes in vital signs, ECGs, and safety laboratory tests PK parameters of TNG462 Pre-treatment and trough pembrolizumab concentrations Changes in SDMA levels in tumor after dosing with TNG462 | — |
Countries
France, Spain
Outcome results
None listed