A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

Exelixis

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor; Advanced Solid Tumor; Immune Sensitive Tumor; Metastatic Solid Tumor

Treatments: Biological: XB628

Study type: Interventional

Funder types: Industry

Identifiers

NCT06952010

XB628-101

Details and patient eligibility

About

This is a phase 1, first-in-human, open-label, dose-escalation study of XB628, a first-in-class bispecific antibody natural killer (NK) cell engager that targets NK group 2 member A (NKG2A), an inhibitory receptor on NK cells, and programmed cell death-ligand 1 (PD-L1).

Full description

This study consists of a Dose-Escalation Stage. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE[s]) of XB628 as a single agent.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Minimum life expectancy of ≥ 12 weeks.
• Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.
• Adequate organ and marrow function.
• Not amenable to curative treatment with surgery or radiation.
• Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.
• Acceptable alternative therapy was received, refused, intolerable, or no longer effective.
• Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.

Exclusion Criteria

• Primary brain tumors or known active brain metastases.
• Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.
• Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.
• Received prior therapy targeting NK cells (eg, monalizumab).
• A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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75 participants in 1 patient group

XB628

Experimental group

Description:

Group(s) of participants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628.

Treatment:

Biological: XB628