XB002 for Advanced Cancers

Recruiting at 99 trial locations

Overseen By Exelixis Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Exelixis

Disqualifiers: Brain metastases, Uncontrolled illness, Pregnancy, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

269 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: XB002 Single-Agent Expansion Cohorts Experimental Treatment 1 Intervention

The MTD or recommended dose from the dose-escalation stage may be further explored in subjects with non-small cell lung cancer \[NSCLC\] (Cohort B), epithelial ovarian cancer (Cohort D), cervical cancer (Cohort E), SCCHN (Cohort F), pancreatic cancer (Cohort G), Esophageal SCC (Cohort H), metastatic castration-resistant prostate cancer (Cohort I), triple-negative breast cancer (Cohort J), hormone-receptor positive breast cancer (Cohort K), endometrial cancer (Cohort L) and tumor agnostic tissue factor-expressing solid tumors (Cohort M).

Group II: XB002 Single-Agent Dose-Escalation Cohorts Experimental Treatment 1 Intervention

Subjects (Cohort A) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.

Group III: XB002 + Nivolumab Dose Expansion Cohorts Experimental Treatment 2 Interventions

The MTD or recommended dose from the dose-escalation stage may be further explored in subjects with non-small cell lung cancer \[NSCLC\] (Cohort BN), SCCHN (Cohort FN).

Group IV: XB002 + Nivolumab Dose Escalation Cohorts Experimental Treatment 2 Interventions

Subjects (Cohort AN) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.

Group V: Experimental: XB002 + Bevacizumab Dose Escalation Cohorts Experimental Treatment 2 Interventions

Subjects (Cohort AB) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.

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

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

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