A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Exelixis
Study ID
NCT05932862
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XL309 — DRUG
    XL309 will be administered orally per assigned schedule.
  • Olaparib — DRUG
    Olaparib will be administered orally per assigned schedule.

Study Details

This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.

Key Dates

Start date
Apr 3, 2024
Status verified
Aug 2025
Primary completion
Jan 3, 2029
Completion
Aug 3, 2029

Study Design

Enrollment
429 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Single Agent Evaluation
    Participants will receive XL309 in sequential cohorts of increasing doses.
  • Experimental: Dose Escalation Combination Therapy
    Participants will receive XL309 in sequential cohorts of increasing doses in combination with olaparib.
  • Experimental: Cohort Expansion Stage Single Agent Evaluation
    The recommended dose as determined in the Escalation Stage will be further studied in advanced solid tumor-specific cohorts.
  • Experimental: Cohort Expansion Stage Combination Therapy Evaluation
    The recommended dose as determined in the Escalation Stage will be further studied in combination with olaparib in advanced solid tumor-specific cohorts.

Primary Outcome Measure

Dose Escalation Stage: Incidence of TEAEs and SAEs; AEs Leading to Dose Modification, Discontinuation, or Death; and Laboratory Abnormalities [ Time Frame: Approximately 24 months ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Exelixis Clinical Site #12Fountain ValleyCalifornia92708-
Exelixis Clinical Site #15JacksonvilleFlorida32224-
Exelixis Clinical Site #8OrlandoFlorida32827-
Exelixis Clinical Site #16TampaFlorida33612-
Exelixis Clinical Site #14RochesterMinnesota55905-
Exelixis Clinical Site #10Kansas CityMissouri64111-
Exelixis Clinical Site #9New BrunswickNew Jersey08901-
Exelixis Clinical Site #5New YorkNew York10029-
Exelixis Clinical Site #7ClevelandOhio44106-
Exelixis Clinical Site #13Oklahoma CityOklahoma73104-
Exelixis Clinical Site #11GermantownTennessee38138-
Exelixis Clinical Site #6NashvilleTennessee37203-
Exelixis Clinical Site #4AustinTexas78758-
Exelixis Clinical Site #1HoustonTexas77030-
Exelixis Clinical Site #2HoustonTexas77030-
Exelixis Clinical Site #3San AntonioTexas78229-

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