XB002 for Advanced Cancers

No longer recruiting at 116 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, XB002, to determine its safety and effectiveness for individuals with advanced solid tumors, such as certain types of lung, ovarian, and breast cancers. Researchers aim to assess how well XB002 works alone or in combination with other cancer drugs like bevacizumab (Avastin) or nivolumab (Opdivo). This trial may be suitable for those with a solid tumor that has recurred or spread after other treatments. Participants must have a confirmed diagnosis of an advanced solid tumor that cannot be surgically removed and must have tried standard treatments that are no longer effective. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this trial have promising safety results from earlier studies. XB002, when used alone, was well-tolerated by patients with advanced solid tumors, meaning most did not experience severe side effects at various doses.

When combined with nivolumab, a drug already approved for several cancers, XB002 also demonstrated good tolerability. Nivolumab is known for its safety across many cancer types and is commonly used in treatments.

Bevacizumab, another drug in this trial, has been thoroughly studied and received FDA approval for several cancers. It is considered safe when used with chemotherapy, with studies confirming its effectiveness and safety.

Overall, previous research suggests that the treatments in this trial are well-tolerated. However, as this is an early-phase trial, the goal is to further confirm safety and determine the optimal dose. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about XB002 because it offers a new approach to treating advanced cancers. Unlike most current treatments, which often target cancer cells broadly, XB002 is designed to specifically target tissue factor-expressing solid tumors, potentially improving precision and reducing side effects. Additionally, when combined with drugs like Bevacizumab and Nivolumab, it may enhance the immune system's ability to fight cancer more effectively. This targeted action and synergistic potential with other therapies make XB002 a promising candidate in the fight against complex cancers like non-small cell lung cancer and triple-negative breast cancer.

What evidence suggests that this trial's treatments could be effective for advanced cancers?

Research shows that XB002 might help fight advanced solid tumors. In early lab studies, XB002 completely shrank tumors in models of cervical cancer and head and neck cancer within 30 days. Initial human trials found that XB002 is well-tolerated, suggesting it might be safe at different doses. In this trial, some participants will receive XB002 with Bevacizumab, which has effectively treated various cancers by cutting off the blood supply to tumors. Others will receive XB002 with Nivolumab, already approved for helping the immune system attack cancer cells in several types of cancer. These findings suggest that the drug combinations tested in this trial could offer new hope for people with advanced cancers. ^{1 3 4 5 6}

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.

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 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?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11791478/

Preclinical Characterization of XB002, an Anti–Tissue ... Remarkably, complete tumor regression was observed in the cervical cancer and head and neck squamous cell carcinoma models within 30 days of treatment. In ...

2. ir.exelixis.com ir.exelixis.com/news-releases/news-release-details/exelixis-announces-promising-initial-dose-escalation-results

Exelixis Announces Promising Initial Dose-Escalation Results ... XB002, a next-generation tissue factor-targeting antibody-drug conjugate, was well-tolerated at multiple dose levels.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04925284

Study of XB002 in Subjects With Solid Tumors (JEWEL-101) This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624001184

Phase 1 Study of the Tissue Factor–Targeting Antibody ... In preclinical studies, XB002 displayed antitumor activity without affecting coagulation. The first-in-human, phase 1, open-label, multicenter JEWEL-101 study ( ...

5. targetedonc.com targetedonc.com/view/xb002-demonstrates-preliminary-safety-tolerability-in-advanced-solid-tumors

XB002 Demonstrates Preliminary Safety/Tolerability in ... Early results from the phase 1 JEWEL-101 study show XB002 is well-tolerated in patients with advanced solid tumors.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825822015232

A dose-escalation and expansion study of the safety and ... A dose-escalation and expansion study of the safety and pharmacokinetics of XB002 in subjects with inoperable locally advanced or metastatic solid tumors (301).