Study of XB010 in Subjects With Solid Tumors

Exelixis

Status and phase: Enrolling; Phase 1

Conditions: Locally Advanced or Metastatic Solid Tumors; Triple Negative Breast Cancer (TNBC); Hormone-receptor-positive Breast Cancer; NSCLC (Non-small Cell Lung Cancer); Head and Neck Squamous Cell Cancer; Esophageal Squamous Cell Cancer

Treatments: Drug: Pembrolizumab; Drug: XB010

Study type: Interventional

Funder types: Industry

Identifiers

NCT06545331

XB010-101

Details and patient eligibility

About

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

Full description

This study consists of Dose-Escalation and Cohort-Expansion Stages. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE[s]) of XB010 as a single agent, and to evaluate XB010 monotherapy RDE(s) in combination with pembrolizumab. The Cohort-Expansion Stage is designed to explore the clinical activity and further characterize the safety and tolerability of XB010 as monotherapy in multiple tumor-specific cohorts.

Enrollment: 396 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Age 18 years or older on the day of consent.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

• Adequate organ and marrow function.

• Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.

  • The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).

• Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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396 participants in 3 patient groups

XB010 Single-Agent Dose Escalation Cohorts

Experimental group

Description:

XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects

Treatment:

Drug: XB010

XB010 + Pembrolizumab Dose Escalation Cohorts

Experimental group

Description:

XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects

Treatment:

Drug: XB010

Drug: Pembrolizumab

XB010 Single-Agent Dose Expansion Cohorts

Experimental group

Description:

XB010 will be administered at the recommended dose for expansion (RDE) every 3 weeks in the following tumor-specific cohorts: non-small cell lung cancer (NSCLC), hormone-receptor-positive breast cancer (HR+BC), head and neck squamous cell cancer (HNSCC), esophageal squamous cell cancer (ESCC), endometrial cancer (EC) and triple-negative breast cancer (TNBC)

Treatment:

Drug: XB010