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 | 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 |
XTX202 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in clinical development and has not been approved by the FDA. The drug is being studied in patients with advanced solid tumors to evaluate its safety and potential efficacy.
XTX202 is being developed by Xilio Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XLO. The company is conducting clinical research on this investigational oncology drug for the treatment of advanced solid tumors.
XTX202 is in Phase 1 clinical development. A Phase 1 study of XTX202 in patients with advanced solid tumors has been completed. The drug remains investigational and is not yet approved for any use.
XTX202 has been studied in a Phase 1 clinical trial identified as NCT05052268, titled "XTX202 in Patients With Advanced Solid Tumors." This trial enrolled 95 participants in the United States and has been completed. The study included adult patients aged 18 years and older.
XTX202 is the primary name used for this investigational drug in clinical development. No alternative names have been reported for this compound in the available clinical trial information.