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XTX301

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Xilio Therapeutics, Inc.|Last Updated: Sep 8, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment358
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05684965XTX301 in Patients With Advanced Solid TumorsPHASE1 RECRUITING 358 — — May 11, 2023Feb 1, 2027Sep 8, 202511 United States
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities (DLTs) (Part 1A only)
From the first dose of the study drug at Cycle 1 Day 1 up to next applicable cycle visit (Cycle 2 Day 1 or Cycle 3 Day 1). Approximately 21 to 42 days. Each cycle is 21 days.
Incidence of treatment-emergent adverse events (TEAEs) and changes in clinical laboratory values
Up to 24 months
Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 2 only)
up to 24 months
Secondary Endpoints
Plasma concentrations of XTX301
Up to 24 months
Maximum observed plasma concentration (Cmax)
Up to 24 months
Time of maximum observed concentration (Tmax)
Up to 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1 - XTX301 Monotherapy Dose Escalation and Pharmacodynamics ExpansionEXPERIMENTALPart 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 CohortsEXPERIMENTALPhase 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) * Cohort 2F: triple-negative breast cancer (TNBC)
Interventions
NameTypeDescription
XTX301DRUGXTX301 monotherapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

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...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05684965primaryCompletionDate: changed
LOWMay 24, 2026NCT05684965studyFirstPostDate: changed