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XTX202

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Xilio Therapeutics, Inc.|Last Updated: May 28, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment95

FDA Designations

No designations recorded

Clinical trial landscape

XTX202 · 1 trial · 1 indication

Phase 1 1
NCT05052268XTX202 in Patients With Advanced Solid TumorsAdvanced Solid Tumor
COMPLETED95 Analytics
PHASE1COMPLETED
XTX202 in Patients With Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)
Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days)

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

Incidence of Treatment-emergent Adverse Events (Phase 1 Only)
Up to 24 months

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.

Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 2 Only)
Up to 24 months

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.

Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Biochemistry
Up to 24 months

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.

Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Hematology
up to 24 months

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.

Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Thyroid Function
Up to 24 months

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.

Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Coagulation
Up to 24 months

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

Secondary Endpoints

Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only)
Up to 24 months
Duration of Response (DOR) (Phase 2 Only)
Up to 24 months
Disease Control Rate (Phase 2 Only)
Up to 24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 XTX202 Dose Escalation and Pharmacodynamics ExpansionEXPERIMENTALPart 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 ExpansionEXPERIMENTALPart 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.

Interventions

NameTypeDescription
XTX202DRUGXTX202 Monotherapy
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

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...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Recent Changes (Last 90 Days)

MEDIUMJun 28, 2026NCT05052268TRIAL_REMOVED: changed
MEDIUMJun 28, 2026NCT05052268TRIAL_REMOVED: changed
MEDIUMJun 28, 2026NCT05052268TRIAL_REMOVED: changed
MEDIUMJun 28, 2026NCT05052268TRIAL_REMOVED: changed

Frequently asked questions about XTX202

What is XTX202 used for?

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.

Who is developing XTX202?

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.

What phase is XTX202 in?

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.

What clinical trials is XTX202 in?

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.

Is XTX202 the same as any other drug?

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.