XB628 for Cancer

Recruiting at 1 trial location

Overseen By Exelixis Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Exelixis

Must not be taking: NK cell therapy

Disqualifiers: Brain tumors, Recent surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for people with advanced or metastatic solid tumors that have come back after treatment. Participants should be expected to live at least 12 weeks, have good organ and bone marrow function, and be fairly active (ECOG status 0-1). They must have tried at least one cancer therapy before and can't be helped by surgery or radiation anymore.

Inclusion Criteria

My doctor expects me to live for at least 12 more weeks.

I am fully active or can carry out light work.

My cancer has returned or spread and is confirmed by lab tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Participants receive escalating dose levels of XB628 to determine the maximum tolerated dose and/or recommended dosage(s) for expansion

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• XB628

Trial Overview The study tests XB628, a new type of drug called a bispecific antibody NK cell engager. It aims to boost the body's natural killer cells by targeting NKG2A on these cells and PD-L1 on tumor cells. The trial will gradually increase doses to find the safest amount.

Participant Groups

Group I: XB628 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD