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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2028-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

XB371

Intervention Type DRUG

Intravenous (IV) infusion.

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.

Group Type EXPERIMENTAL

XB371

Intervention Type DRUG

Intravenous (IV) infusion.

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.

Group Type EXPERIMENTAL

XB371

Intervention Type DRUG

Intravenous (IV) infusion.

Interventions

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XB371

Intravenous (IV) infusion.

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No