XB002 for Advanced Cancers

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Exelixis

No Placebo Group

Breakthrough Therapy

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 cancer is confirmed, cannot be removed by surgery, and has spread or come back.

My cancer has worsened despite my last treatment.

I am fully active or can carry out light work.

I am not pregnant and can become pregnant.

Exclusion Criteria

I do not have any severe illnesses that are not under control.

I have not had major surgery in the last 4 weeks.

Treatment Details

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.

4Treatment groups

Experimental Treatment

Group I: XB002 Single-Agent Expansion CohortsExperimental Treatment1 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 CohortsExperimental Treatment1 Intervention

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

Group III: XB002 + Nivolumab Dose Expansion CohortsExperimental Treatment2 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), Esophageal SCC (Cohort HN).

Group IV: XB002 + Nivolumab Dose Escalation CohortsExperimental Treatment2 Interventions

Subjects (Cohort AN) 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: