269 Participants Needed

XB002 for Advanced Cancers

Recruiting at 99 trial locations
Bo
EC
Overseen ByExelixis Clinical Trials
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Exelixis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called XB002, given through an IV periodically, to see if it can help patients with advanced solid tumors. The drug is tested alone and with other cancer treatments. Researchers are checking if it is safe and effective in shrinking or stopping tumor growth.

Are You a Good Fit for This Trial?

This trial is for adults with various advanced solid tumors that can't be removed or have spread, and who've had their disease get worse after standard treatment. They should be relatively healthy (ECOG 0-1), not pregnant, willing to use birth control, and have a recent biopsy available. People with certain heart issues, brain metastases, severe allergies to study drugs, or major surgery within the last month can't join.

Inclusion Criteria

My tumor sample was collected either about 2 years ago or freshly within the last 60 days.
I am fully active or can carry out light work.
My cancer is confirmed, cannot be removed by surgery, and has spread or come back.
See 7 more

Exclusion Criteria

My brain metastases have been treated and stable for over 4 weeks.
Receipt of prior therapies as defined in study protocol
I do not have any severe illnesses that are not under control.
See 5 more

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 XB002 alone or in combination with nivolumab or bevacizumab to determine the maximum tolerated dose (MTD) or recommended dose (RD)

18 months
Regular visits as per protocol

Cohort-Expansion

Participants receive the MTD or RD of XB002 to evaluate preliminary efficacy and safety in specific cancer cohorts

12 months
Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 months

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Nivolumab
  • XB002
Trial Overview The JEWEL-101 study is testing XB002 alone and in combination with Nivolumab or Bevacizumab in patients with solid tumors like breast cancer and lung cancer. It's an early-phase trial to check how safe these treatments are, what doses are best, and if they work against the cancer.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: XB002 Single-Agent Expansion CohortsExperimental Treatment1 Intervention
Group II: XB002 Single-Agent Dose-Escalation CohortsExperimental Treatment1 Intervention
Group III: XB002 + Nivolumab Dose Expansion CohortsExperimental Treatment2 Interventions
Group IV: XB002 + Nivolumab Dose Escalation CohortsExperimental Treatment2 Interventions
Group V: Experimental: XB002 + Bevacizumab Dose Escalation CohortsExperimental Treatment2 Interventions

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺
Approved in European Union as Avastin for:
🇺🇸
Approved in United States as Avastin for:
🇯🇵
Approved in Japan as Avastin for:
🇨🇦
Approved in Canada as Avastin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials
126
Recruited
20,500+
Michael M. Morrissey profile image

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 profile image

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security