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XL309

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Exelixis, Inc.|Last Updated: Sep 5, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment429
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05932862A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid TumorsPHASE1 RECRUITING 429 — — Apr 3, 2024Aug 3, 2029Sep 5, 202516 United States
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Study Endpoints
Primary Endpoints
Dose Escalation Stage: Incidence of TEAEs and SAEs; AEs Leading to Dose Modification, Discontinuation, or Death; and Laboratory Abnormalities
Approximately 24 months

Adverse events will be recorded and severity graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Dose Escalation Stage: Incidence of Dose-Limiting Toxicities (DLTs)
Approximately 24 months
Dose Escalation Stage: XL309 Exposure Over Time Measured as Area Under the Plasma Concentration Curve (AUC)
Approximately 24 months
Dose Escalation Stage: XL309 Maximum Plasma Concentration (Cmax)
Approximately 24 months
Dose Escalation Stage: XL309 Time to Cmax
Approximately 24 months
Dose Escalation Stage: XL309 Trough Concentration (Ctrough)
Approximately 24 months

Lowest concentration of drug in the bloodstream, measured just before the next dose is administered.

Dose Escalation Stage: XL309 Apparent Clearance (CL/F)
Approximately 24 months
Cohort Expansion Stage: Incidence of TEAEs and SAEs; AEs Leading to Dose Modification, Discontinuation, or Death; and Laboratory Abnormalities
Approximately 24 months

Adverse events will be recorded and severity graded using CTCAE version 5.0.

Cohort Expansion Stage: Objective Response Rate (ORR)
Approximately 24 months

ORR will be measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the Investigator. ORR for prostate cancer will be based on Prostate Cancer Working Group 3 (PCWG3) criteria, as assessed by the Investigator

Secondary Endpoints
Dose Escalation Stage: Olaparib Exposure Over Time Measured as Area Under the Plasma Concentration Curve (AUC) at Steady State
Approximately 24 months
Dose Escalation Stage: Olaparib Cmax at Steady State
Approximately 24 months
Dose Escalation Stage: Olaparib Ctrough at Steady State
Approximately 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation Single Agent EvaluationEXPERIMENTALParticipants will receive XL309 in sequential cohorts of increasing doses.
Dose Escalation Combination TherapyEXPERIMENTALParticipants will receive XL309 in sequential cohorts of increasing doses in combination with olaparib.
Cohort Expansion Stage Single Agent EvaluationEXPERIMENTALThe recommended dose as determined in the Escalation Stage will be further studied in advanced solid tumor-specific cohorts.
Cohort Expansion Stage Combination Therapy EvaluationEXPERIMENTALThe recommended dose as determined in the Escalation Stage will be further studied in combination with olaparib in advanced solid tumor-specific cohorts.
Interventions
NameTypeDescription
XL309DRUGXL309 will be administered orally per assigned schedule.
OlaparibDRUGOlaparib will be administered orally per assigned schedule.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Key Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. Male or female aged 18 years or older. 3. Eastern Cooperative Oncology Group performance status 0 or 1. 4. Adequate bone marrow and organ function. 5. Participant-disease Characteristics Dose-Escala...

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, 2026NCT05932862primaryCompletionDate: changed
LOWMay 24, 2026NCT05932862studyFirstPostDate: changed