Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XTX202 · 1 trial · 1 indication
All participants in Phase 1 Part 1A (Dose Escalation) who received at least 1 dose of XTX202 and experienced a DLT. DLTs were defined as the following: * Any treatment-related Grade ≥ 3 toxicity * Any Grade febrile neutropenia * The following nonhematologic exceptions: * Grade 3 nausea or vomiting lasting \< 3 days * Grade 3 fatigue lasting \< 7 days * Any treatment-related toxicity that resulted in a treatment delay of ≥ 7 days
Treatment-emergent adverse event (TEAE) is defined as any adverse event that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. Adverse events are graded using the NCI CTCAE version 5.0.
Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response is based on Investigator assessment according to RECIST v1.1. In the analysis set used for ORR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. Missing = number of patients with missing baseline and/or post baseline laboratory value
| Arm | Type | Description |
|---|---|---|
| Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion | EXPERIMENTAL | Part 1A Dose Escalation of XTX202 administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 doses (RP2Ds). Part 1B Evaluation of XTX202 in patients with selected advanced solid tumors to further characterize the pharmacodynamic profile of XTX202 |
| Phase 2 XTX202 Dose Expansion | EXPERIMENTAL | Part 2A will enroll patients with metastatic renal cell carcinoma who have progressed following standard-of-care treatment. Part 2B will enroll patients with melanoma who have progressed following standard-of-care treatment. |
| Name | Type | Description |
|---|---|---|
| XTX202 | DRUG | XTX202 Monotherapy |
Inclusion Criteria: 1. Disease Criteria * Phase 1, Part 1a: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available * Phase 1, Part 1b: Histologically or cyto...
| 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 |
XTX202 is an investigational therapy being studied in adults with advanced solid tumors. It is a small molecule developed by Xilio Therapeutics, Inc. for oncology indications. The clinical program has focused on patients with advanced solid tumors, and the drug has been evaluated in a Phase 1 trial.
XTX202 is being developed by Xilio Therapeutics, Inc., which trades on the Nasdaq under the ticker XLO. Xilio is a clinical-stage biotechnology company focused on oncology. The company is responsible for the research, development, and clinical evaluation of XTX202.
XTX202 is in Phase 1 clinical development. It has been evaluated in a completed Phase 1 trial in patients with advanced solid tumors. As an investigational therapy, XTX202 has not been approved by the FDA for any indication and remains in clinical testing.
XTX202 has been studied in a Phase 1 clinical trial, NCT05052268, titled "XTX202 in Patients With Advanced Solid Tumors." The trial enrolled 95 patients with advanced solid tumors, was conducted in the United States, and is now completed. It included adults 18 years and older.
Yes, the XTX202 clinical program is biomarker selected, meaning trial enrollment was guided by specific biological markers. The Phase 1 trial NCT05052268 evaluated XTX202 in patients with advanced solid tumors and enrolled 95 participants. Biomarker selection is often used in oncology to target patients most likely to respond.