Recruiting
Phase 1

XB371

Sponsor:

Exelixis

Code:

NCT07123103

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

XB371

Study Details

Brief summary:

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.

Conditions

Solid Tumors

Study ID

NCT07123103

Start date

Aug 18, 2025

Status verified date

Feb, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Minimum life expectancy of ≥ 12 weeks.
  • Recurrent locally advanced or metastatic solid tumors.
  • Adequate end organ and bone marrow function.

Key Exclusion Criteria:

  • Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.
  • History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.
  • Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea.
  • Known history of immunodeficiency virus (HIV) unless specific criteria are met.
  • Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody.
  • Major surgery within 4 weeks before the first dose of study treatment.
  • Received radiation therapy within 2 weeks before the first dose of study treatment.
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

XB371

Intravenous (IV) infusion.

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) ]
  • Number of Participants with a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to approximately 7 months ]

Central Contacts and Locations

Central contacts

Exelixis Clinical Trials

1-888-EXELIXIS (888-393-5494)druginfo@exelixis.com

Backup or International

1-650-837-7400

Locations

Exelixis Clinical Site #5

Recruiting

Rogers, Arkansas, United States, 72758

Exelixis Clinical Site #9

Recruiting

Los Angeles, California, United States, 90033

Exelixis Clinical Site #6

Recruiting

Washington D.C., District of Columbia, United States, 20057

Exelixis Clinical Site #4

Recruiting

Orlando, Florida, United States, 32827

Exelixis Clinical Site #3

Recruiting

Grand Rapids, Michigan, United States, 49546

Exelixis Clinical Site #7

Recruiting

New Brunswick, New Jersey, United States, 08901

Exelixis Clinical Site #2

Recruiting

Huntersville, North Carolina, United States, 28078

Exelixis Clinical Site #8

Recruiting

Houston, Texas, United States, 77030

Exelixis Clinical Site #1

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Exelixis

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exelixis on 2026-02-17.