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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
XL309 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently being studied in a Phase 1 clinical trial in participants with advanced solid tumors, both alone and in combination with other therapies.
XL309 targets USP1, an enzyme involved in DNA repair pathways. As a USP1 inhibitor, it is designed to interfere with tumor cell survival mechanisms, potentially making cancer cells more susceptible to treatment.
XL309 is being developed by Exelixis, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EXEL. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced solid tumors.
XL309 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with advanced solid tumors.
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, with an enrollment target of 429 participants.
Yes, XL309 is also known as ISM3091. The clinical trial NCT05932862 refers to the drug as XL309 (ISM3091), indicating that both names refer to the same investigational compound being developed for advanced solid tumors.