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Also known as ISM3091
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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
XL309 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being developed by Exelixis, Inc. and is currently in Phase 1 clinical development. The study enrolls adults with advanced solid tumors and evaluates XL309 both as a single agent and in combination with other therapies.
XL309 targets USP1, a deubiquitinase enzyme, and acts as a USP1 inhibitor. By inhibiting USP1, the drug is designed to interfere with DNA damage response pathways in tumor cells. This mechanism is being explored in advanced solid tumors, with biomarker-selected patient enrollment in the ongoing Phase 1 trial.
XL309 is being developed by Exelixis, Inc., a biopharmaceutical company whose common stock trades on the Nasdaq under the ticker symbol EXEL. Exelixis is the sponsor of the ongoing Phase 1 clinical trial evaluating XL309 in patients with advanced solid tumors.
XL309 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 study is currently recruiting participants and is designed to evaluate XL309 alone and in combination in adults with advanced solid tumors.
XL309 is being evaluated in a single Phase 1 trial, NCT05932862, titled A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors. The trial is recruiting, has an estimated enrollment of 429 participants, and is conducted in the United States.
Yes, XL309 is also known as ISM3091. The ongoing Phase 1 trial is registered as A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors, confirming that both names refer to the same investigational USP1 inhibitor developed by Exelixis.