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RecruitingInterventionalPhase 1

A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

NCT ID: NCT06952010Sponsor: ExelixisLast updated: 2026-05-14

Summary

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

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.

Arms & interventions

  • BiologicalXB628

    Intravenous infusion(s)

Outcome measures

Primary

  • Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: 21 days

  • Number of Participants with Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs), and Adverse Events (AEs) Leading to Dose Withholding, Treatment Discontinuation, or Death

    Time frame: 27 months

Secondary

  • Area Under the Concentration-time Curve (AUC) of XB628

    Time frame: 25 months

  • Maximum Plasma Concentration (Cmax) of XB628

    Time frame: 25 months

  • Time to Maximum Concentration (Tmax) of XB628

    Time frame: 25 months

  • Elimination Half-life (T1/2) of XB628

    Time frame: 25 months

  • Apparent Clearance (CL/F) of XB628

    Time frame: 25 months

  • Trough Concentration (Ctrough) of XB628

    Time frame: 25 months

  • Number of Participants with Antidrug Antibody (ADA) Response to XB628

    Time frame: 25 months

  • Objective Response Rate (ORR)

    Time frame: 27 months

  • Duration of Response (DOR)

    Time frame: 27 months

  • RDE for XB628

    Time frame: 25 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (11)

Exelixis Clinical Site #5

San Francisco, California, 94158

Recruiting

Exelixis Clinical Site #4

New Haven, Connecticut, 06520

Recruiting

Exelixis Clinical Site #8

Tampa, Florida, 33612

Recruiting

Exelixis Clinical Site #10

Boston, Massachusetts, 02114

Recruiting

Exelixis Clinical Site #11

Boston, Massachusetts, 02114

Recruiting

Exelixis Clinical Site #6

St Louis, Missouri, 63108

Recruiting

Exelixis Clinical Site #7

New York, New York, 10029

Recruiting

Exelixis Clinical Site #1

Hickory, North Carolina, 28602

Recruiting

Exelixis Clinical Site #3

Nashville, Tennessee, 37203

Recruiting

Exelixis Clinical Site #9

Houston, Texas, 77030

Recruiting

Exelixis Clinical Site #2

San Antonio, Texas, 78229

Recruiting