XB628 for Cancer

Recruiting at 6 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called XB628 for individuals with certain types of advanced or metastatic solid tumors. The main goal is to assess the safety of XB628 and determine the right dose. XB628 aims to enhance the body's natural killer cells, a part of the immune system, to better fight cancer. Those who have tried other cancer treatments without success or are unsuitable for surgery or radiation might be good candidates. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that XB628 is a new treatment designed to help the body's immune cells fight cancer. Early tests in labs and on animals indicate that XB628 can destroy cancer cells. These tests suggest it might be effective even when cancer cells outnumber immune cells.

However, limited information exists about its safety in humans. As this trial is in an early stage, the main goal is to determine if the treatment is safe for people. Researchers are still learning about how well people tolerate it and what side effects might occur. This phase is crucial for identifying potential problems before progressing to larger studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about XB628 because it offers a new approach to treating advanced or metastatic solid tumors. Unlike standard treatments like chemotherapy or targeted therapy, which often attack cancer cells directly or block specific growth signals, XB628 works by a unique mechanism that might boost the body's own ability to fight cancer. This novel approach could potentially lead to better outcomes for patients who have not responded to existing therapies, making XB628 an exciting prospect in cancer treatment.

What evidence suggests that XB628 might be an effective treatment for cancer?

Studies have shown that XB628, the investigational treatment tested in this trial, shows promise for treating cancer. In lab tests, XB628 effectively killed cancer cells, even when cancer cells outnumbered the immune cells it interacts with. In animal studies, XB628 also demonstrated the ability to shrink tumors. This treatment blocks specific proteins, NKG2A and PD-L1, which typically help cancer cells evade the immune system. These early findings suggest XB628 could enhance the immune system's ability to fight cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Exelixis

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06952010

A Study of XB628 in Participants With Recurrent Advanced ... Group(s) of participants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628. Intervention/Treatment ...

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/6067/758675/Abstract-6067-Preclinical-evaluation-of-XB628-A

Abstract 6067: Preclinical evaluation of XB628: A novel PD-L1 ... XB628 promoted tumor cell death even when tumor cells significantly outnumbered NK cells. In a genetically engineered mouse model, XB628 ...

3. ir.exelixis.com ir.exelixis.com/news-releases/news-release-details/exelixis-present-positive-preclinical-data-across-its-pipeline

Exelixis to Present Positive Preclinical Data Across Its Pipeline ... Data from this analysis show that XB628 is efficacious in tumor cell killing in vitro and in vivo, supporting advancement of this molecule into ...

4. trial.medpath.com trial.medpath.com/news/d1924a62951bf821/exelixis-initiates-phase-1-trial-of-xb628-a-novel-bispecific-nk-cell-engager-for-advanced-solid-tumors

Exelixis Initiates Phase 1 Trial of XB628, a Novel Bispecific NK ... The trial is recruiting participants with recurrent advanced or metastatic solid tumorsSearch disease, suggesting a basket trial approach that ...

5. medicine.yale.edu medicine.yale.edu/ycci/clinicaltrials/trial/a-phase-1-study-of-xb628-in-participants-with-solid-tumors/

A Phase 1 Study of XB628 in Participants With Recurrent ... 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 ...

6. biospace.com biospace.com/press-releases/invenra-highlights-exelixis-initiation-of-phase-1-clinical-study-evaluating-xb628-a-first-in-class-bispecific-antibody-in-participants-with-recurrent-advanced-or-metastatic-solid-tumors

Invenra Highlights Exelixis' Initiation of Phase 1 Clinical ... XB628 is a first-in-class bispecific antibody natural killer (NK) cell engager that targets NK group 2 member A (NKG2A), an inhibitory receptor ...

7. synapse.patsnap.com synapse.patsnap.com/drug/0494b09f12604e338411727c4fec8bfe

XB-628 - Drug Targets, Indications, Patents Data analysis from the XB628 program demonstrated the molecule's tumor cell killing activity both in vitro and in vivo, supporting advancement of this molecule ...