Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
S095035 · 1 trial · 1 indication
Phase 1 only
Phase 1 only
Phase 1 only
Phase 2 only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment and by blinded independent central review (BICR)
| Arm | Type | Description |
|---|---|---|
| Phase 1 Arm 1 - S095035 single-agent dose escalation | EXPERIMENTAL | - |
| Phase 1 Arm 2 - S095035-TNG462 combination dose escalation | EXPERIMENTAL | - |
| Phase 2 Arm 1a NSCLC - S095035 single-agent dose expansion | EXPERIMENTAL | Non-Small Cell Lung Cancer |
| Phase 2 Arm 1b BTC - S095035 single-agent dose expansion | EXPERIMENTAL | Biliary Tract Cancer |
| Phase 2 Arm 1c PDAC - S095035 single-agent dose expansion | EXPERIMENTAL | Pancreatic Ductal Adenocarcinoma |
| Phase 2 Arm 1d Basket arm - S095035 single-agent dose expansion | EXPERIMENTAL | - |
| Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansion | EXPERIMENTAL | Biliary Tract Cancer |
| Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansion | EXPERIMENTAL | - |
| Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansion | EXPERIMENTAL | Pancreatic Ductal Adenocarcinoma |
| Name | Type | Description |
|---|---|---|
| S095035 | DRUG | S095035 will be taken orally every day in 28-day cycles. |
| TNG462 | DRUG | TNG462 will be taken orally every day in 28-day cycles. |
Inclusion Criteria: * Estimated life expectancy ≥3 months. * ECOG PS 0-1 * Participants able to comply with highly effective method of birth control requirements. * Participants with histologically confirmed advanced or metastatic solid tumor's (excluding central nervous system tumors other than ID...
S095035 is an investigational small molecule being developed for the treatment of MTAP-deleted solid tumors. It is currently being studied in a Phase 1 clinical trial in adult participants with advanced or metastatic solid tumors that have a deletion of the MTAP gene.
S095035 is being developed by Tango Therapeutics, Inc. (NASDAQ: TNGX). The company is conducting a Phase 1 clinical trial of S095035 as a single agent and in combination for the treatment of MTAP-deleted solid tumors.
S095035 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is active but not recruiting participants, and is studying the drug in patients with MTAP-deleted solid tumors.
S095035 is being studied in a Phase 1 clinical trial with the identifier NCT06188702. The trial is titled 'S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP' and is enrolling approximately 60 participants.
The S095035 Phase 1 clinical trial (NCT06188702) is being conducted in multiple countries, including the United States, Australia, France, Germany, Italy, Japan, and Spain. The trial enrolls adults aged 18 years and older with MTAP-deleted solid tumors.