XB371 for Cancer

Recruiting at 4 trial locations

Overseen By Exelixis Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Exelixis

Disqualifiers: Brain tumors, ILD, HIV, HCV, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of a new cancer treatment, XB371. Participants will receive varying doses of XB371 to assess their body's reactions, with random assignments to different dose levels. The trial seeks individuals with recurrent locally advanced or metastatic solid tumors who can perform daily activities independently. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received any systemic anticancer therapy within 4 weeks before starting the trial.

Is there any evidence suggesting that XB371 is likely to be safe for humans?

Research has shown that XB371 has yielded promising results in early lab studies. XB371 is a treatment designed to target cancer cells. Currently, it is undergoing testing in a Phase 1 clinical trial, so its safety for humans remains uncertain. Phase 1 trials are the initial step in testing new treatments in people, focusing primarily on safety and tolerability. While early lab results are encouraging, more information from these ongoing human trials is needed to confirm its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

XB371 is unique because it targets cancer cells with a specific mechanism of action that differs from traditional treatments like chemotherapy and radiation. While most cancer treatments aim to kill rapidly dividing cells, XB371 selectively targets tumor cells based on specific tumor types, potentially offering a more precise and less toxic approach. Researchers are excited about XB371 because it may allow for tailored dosing, maximizing effectiveness while minimizing side effects, and it can be adjusted every 3 weeks based on patient response, offering flexibility in treatment scheduling.

What evidence suggests that XB371 might be an effective treatment for cancer?

Research has shown that XB371 produced promising results in early tests. It effectively shrank tumors and killed cancer cells in the lab, working well on various cancer cell types. In animal studies, XB371 increased survival time and reduced tumor size. These findings support testing XB371 in humans to determine its potential benefits for people with cancer. Participants in this trial will receive XB371 in different treatment arms, including dose-escalation and dose-expansion cohorts, to evaluate its effectiveness and safety. ^{2 3 4 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 individuals with advanced or widespread solid tumors. Specific eligibility criteria are not provided, but typically participants must have a certain type and stage of cancer, be in good overall health aside from their cancer, and meet other study-specific requirements.

Inclusion Criteria

Minimum life expectancy of ≥ 12 weeks

I am fully active or can carry out light work.

My cancer has returned or spread and is not blood-related.

Exclusion Criteria

I had radiation therapy less than 2 weeks ago.

Known history of immunodeficiency virus (HIV) unless specific criteria are met

Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive escalating doses of XB371 every 3 weeks of a 21-day cycle until meeting the criteria for treatment discontinuation

Variable, based on individual response

Dose-expansion Part A

Participants with Tumor Type 1 are randomized to receive XB371 at one of two recommended dose levels every 3 weeks of a 21-day cycle until meeting the criteria for treatment discontinuation

Variable, based on individual response

Dose-expansion Part B

Participants with Tumor Type 2 receive XB371 at the recommended dose level every 3 weeks of a 21-day cycle until meeting the criteria for treatment discontinuation

Variable, based on individual response

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• XB371

Trial Overview The trial is testing the safety and tolerability of a new treatment called XB371 on people with solid tumors. The first part involves gradually increasing doses to find the right amount (dose-escalation), while later parts involve more patients at this dose (expansion cohorts).

How Is the Trial Designed?

Group I: Dose-expansion Cohorts: Part B Experimental Treatment 1 Intervention

Participants with Tumor Type 2 (tumor type will be selected based on available data) will receive XB371 at the recommended dose level every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.

Group II: Dose-expansion Cohorts: Part A Experimental Treatment 1 Intervention

Participants with Tumor Type 1 (tumor type will be selected based on available data) will be randomized to receive XB371 at one of two recommended dose levels (recommended dose \[RD\]-1 or RD-2) every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.

Group III: Dose-escalation Cohorts Experimental Treatment 1 Intervention

Participants will receive escalating doses of XB371 every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.

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. 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 ... Results to be presented support in vitro cell killing activity and in vivo efficacy, supporting the advancement of XB371 into clinical ...

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/2936/756578/Abstract-2936-Preclinical-characterization-of

Preclinical characterization of XB371, a novel anti-tissue factor ... In the HPAF-II CDX model, XB371 demonstrated dose-dependent anti-tumor activity, with significant increases in median survival and tumor volume ...

3. exelixismedicalaffairs.com exelixismedicalaffairs.com/explore-our-pipeline/explore-xb371/

XB371: TF-TOPOi ADC XB371 has demonstrated in vitro cell killing properties across multiple xenograft cancer cell lines that express TF, in vitro bystander activity, in vitro ...

4. synapse.patsnap.com synapse.patsnap.com/drug/823ccb1c31f342afb96b1d7885501bae

XB-371 - Drug Targets, Indications, Patents Findings from XB371 non-clinical experiments demonstrated potent anti-tumor activity in vivo across a range of human tumor xenograft models including colorectal ...

5. finance.yahoo.com finance.yahoo.com/news/exelixis-present-positive-preclinical-data-211500888.html

Exelixis to Present Positive Preclinical Data Across Its ... Results to be presented support in vitro cell killing activity and in vivo efficacy, supporting the advancement of XB371 into clinical ...

6. withpower.com withpower.com/trial/phase-1-tumors-solid-7-2025-2e886

XB371 for Cancer This Phase 1 medical study run by Exelixis is evaluating whether XB371 will have tolerable side effects & efficacy for patients with Solid Tumors.

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-xb371-administered-in-participants-with-locally-advanced-or-metastatic-solid-tumors

A Study of XB371 Administered in Participants With Locally ... The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts ...