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

Exelixis

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors

Treatments: Drug: XB371

Study type: Interventional

Funder types: Industry

Identifiers

NCT07123103

XB371-101

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Dose-escalation Cohorts

Experimental group

Description:

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.

Treatment:

Drug: XB371

Dose-expansion Cohorts: Part A

Experimental group

Description:

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.

Treatment:

Drug: XB371

Dose-expansion Cohorts: Part B

Experimental group

Description:

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.

Treatment:

Drug: XB371