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XTX301 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Phase 1 - XTX301 Monotherapy Dose Escalation and Pharmacodynamics Expansion | EXPERIMENTAL | Part 1A Dose Escalation of XTX301 administered in ascending doses to patients with advanced solid tumors to assess the safety and tolerability and determine/define MTD and/or the highest recommended Phase 2 dose (RP2D). Part 1B Evaluation of XTX301 in patients with selected advanced solid tumors to further characterize the pharmacodynamics profile of XTX301. |
| Phase 2 - XTX301 Monotherapy Dose Expansion in Disease-Specific Cohorts | EXPERIMENTAL | Phase 2 will further evaluate the safety and antitumor activity/efficacy of XTX301 monotherapy in disease-specific expansion cohorts of patients with select tumors, namely: * Cohort 2A: head and neck squamous cell carcinoma (HNSCC) * Cohort 2B: melanoma (patients with uveal melanoma are excluded) * Cohort 2C: non-small cell lung cancer (NSCLC) * Cohort 2D: ovarian cancer * Cohort 2E: castrate-resistant prostate cancer (CRPC)/androgen pathway modulation-resistant prostate cancer (APMR-PC) * Cohort 2F: triple-negative breast cancer (TNBC) |
| Name | Type | Description |
|---|---|---|
| XTX301 | DRUG | XTX301 monotherapy |
Inclusion Criteria: • Disease Criteria: Part 1A - Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available. Part 1B- Any histo...
| 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 |
XTX301 is an investigational therapy being studied for the treatment of advanced solid tumors. It is in Phase 1 clinical development and is being evaluated in patients with advanced solid tumors, with enrollment limited to biomarker-selected participants. XTX301 has not been approved for any indication.
XTX301 targets interleukin-12, or IL-12, a cytokine that plays a role in immune system activation. XTX301 is a small molecule designed to act on this cytokine target. By engaging IL-12, the therapy is intended to stimulate antitumor immune activity in patients with advanced solid tumors.
XTX301 is being developed by Xilio Therapeutics, Inc., which trades under the ticker XLO. The company is the sponsor of the Phase 1 clinical trial evaluating XTX301 in patients with advanced solid tumors. Xilio Therapeutics is an oncology-focused biotechnology company.
XTX301 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory authority. The Phase 1 trial is currently recruiting participants with advanced solid tumors, and no completed trials of XTX301 have been reported.
XTX301 is being evaluated in one active clinical trial, NCT05684965, titled "XTX301 in Patients With Advanced Solid Tumors." The trial is a Phase 1 study that is currently recruiting, with an estimated enrollment of 358 participants. It is conducted in the United States and includes adult patients aged 18 years and older.