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

NCT ID: NCT06952010

Last Updated: 2025-12-26

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Solid Tumor Advanced Solid Tumor Metastatic Solid Tumor Immune Sensitive Tumor

Keywords

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XB628 Solid tumor Advanced solid tumor Metastatic solid tumor Immune sensitive tumor PD-L1

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XB628

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

Group Type EXPERIMENTAL

XB628

Intervention Type BIOLOGICAL

Intravenous infusion(s)

Interventions

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XB628

Intravenous infusion(s)

Intervention Type BIOLOGICAL

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.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exelixis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Exelixis

Locations

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Exelixis Site #5

San Francisco, California, United States

Site Status RECRUITING

Exelixis Site #4

New Haven, Connecticut, United States

Site Status RECRUITING

Exelixis Clinical Site #8

Tampa, Florida, United States

Site Status RECRUITING

Exelixis Clinical Site #10

Boston, Massachusetts, United States

Site Status RECRUITING

Exelixis Site #6

St Louis, Missouri, United States

Site Status RECRUITING

Exelixis Site #7

New York, New York, United States

Site Status RECRUITING

Exelixis Clinical Site #1

Hickory, North Carolina, United States

Site Status RECRUITING

Exelixis Clinical Site #3

Nashville, Tennessee, United States

Site Status RECRUITING

Exelixis Clinical Site #9

Houston, Texas, United States

Site Status RECRUITING

Exelixis Clinical Site #2

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Exelixis Clinical Trials

Role: CONTACT

Phone: 1-888-EXELIXIS (888-393-5494)

Email: [email protected]

Backup or International

Role: CONTACT

Phone: 650-837-7400

Other Identifiers

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XB628-101

Identifier Type: -

Identifier Source: org_study_id