Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XL309 · 1 trial · 1 indication
Adverse events will be recorded and severity graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Lowest concentration of drug in the bloodstream, measured just before the next dose is administered.
Adverse events will be recorded and severity graded using CTCAE version 5.0.
ORR will be measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the Investigator. ORR for prostate cancer will be based on Prostate Cancer Working Group 3 (PCWG3) criteria, as assessed by the Investigator
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Single Agent Evaluation | EXPERIMENTAL | Participants will receive XL309 in sequential cohorts of increasing doses. |
| Dose Escalation Combination Therapy | EXPERIMENTAL | Participants will receive XL309 in sequential cohorts of increasing doses in combination with olaparib. |
| Cohort Expansion Stage Single Agent Evaluation | EXPERIMENTAL | The recommended dose as determined in the Escalation Stage will be further studied in advanced solid tumor-specific cohorts. |
| Cohort Expansion Stage Combination Therapy Evaluation | EXPERIMENTAL | The recommended dose as determined in the Escalation Stage will be further studied in combination with olaparib in advanced solid tumor-specific cohorts. |
| Name | Type | Description |
|---|---|---|
| XL309 | DRUG | XL309 will be administered orally per assigned schedule. |
| Olaparib | DRUG | Olaparib will be administered orally per assigned schedule. |
Key Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. Male or female aged 18 years or older. 3. Eastern Cooperative Oncology Group performance status 0 or 1. 4. Adequate bone marrow and organ function. 5. Participant-disease Characteristics Dose-Escala...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
XL309 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, and its safety and efficacy have not yet been established. The drug is being evaluated alone and in combination in participants with advanced solid tumors.
XL309 targets USP1, an enzyme involved in DNA repair pathways. As a USP1 inhibitor, it is designed to interfere with this enzyme's activity, which may have therapeutic potential in oncology. The drug is being investigated for its effects in patients with advanced solid tumors.
XL309 is being developed by Exelixis, Inc., a biopharmaceutical company. Exelixis is listed on the stock exchange under the ticker symbol EXEL. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
XL309 is currently in Phase 1 clinical development. This early-stage trial is designed to assess the drug's safety, tolerability, and pharmacokinetics in patients with advanced solid tumors. The drug is investigational and has not yet been approved by regulatory authorities.
XL309 is being studied in a Phase 1 clinical trial with the identifier NCT05932862. This trial is recruiting participants with advanced solid tumors and is being conducted in the United States. The study is evaluating XL309 alone and in combination with other treatments, with a planned enrollment of 429 participants.
Yes, XL309 is also known as ISM3091. The clinical trial for this drug, NCT05932862, refers to it as XL309 (ISM3091), indicating that both names are used for the same investigational compound. This compound is being developed by Exelixis, Inc. for the treatment of advanced solid tumors.