A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Rogers, Arkansas.

Sponsor
Exelixis
Study ID
NCT07123103
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • XB371 — DRUG
    Intravenous (IV) infusion.

Study Details

The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.

Key Dates

Start date
Aug 18, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
Feb 29, 2028

Study Design

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

Arms

  • Experimental: Dose-escalation Cohorts
    Participants will receive escalating doses of XB371 every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
  • Experimental: Dose-expansion Cohorts: Part A
    Participants with Tumor Type 1 (tumor type will be selected based on available data) will be randomized to receive XB371 at one of two recommended dose levels (recommended dose \[RD\]-1 or RD-2) every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
  • Experimental: Dose-expansion Cohorts: Part B
    Participants with Tumor Type 2 (tumor type will be selected based on available data) will receive XB371 at the recommended dose level every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.

Primary Outcome Measure

Number of Participants with a Dose-limiting Toxicity (DLT) [ Time Frame: Up to the end of the first cycle (Up to Day 21 of a 21-day cycle) ]

Central Contacts

  • Exelixis Clinical Trials
    1-888-EXELIXIS (888-393-5494)
    [email protected]
  • Backup or International
    1-650-837-7400

Locations (9)

FacilityCityStateZIPSite coordinators
Exelixis Clinical Site #5RogersArkansas72758-
Exelixis Clinical Site #9Los AngelesCalifornia90033-
Exelixis Clinical Site #6Washington D.C.District of Columbia20057-
Exelixis Clinical Site #4OrlandoFlorida32827-
Exelixis Clinical Site #3Grand RapidsMichigan49546-
Exelixis Clinical Site #7New BrunswickNew Jersey08901-
Exelixis Clinical Site #2HuntersvilleNorth Carolina28078-
Exelixis Clinical Site #8HoustonTexas77030-
Exelixis Clinical Site #1San AntonioTexas78229-

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