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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent
Subjects with specific documented radiographic disease progression during or following their last systemic anticancer therapy for various cancer types
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study Summary
This trial is testing a new drug, XB002, to see if it is safe and effective in treating advanced solid tumors. The trial will involve escalating doses of the drug to test for safety and tolerability, as well as expanding the study to additional patients.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site where the drug enters your body through a vein. There might also be general symptoms like tiredness or nausea as well as specific organ-related issues depending on how each person reacts to XB002 and its combinations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed, cannot be removed by surgery, and has spread or come back.
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My cancer has worsened despite my last treatment.
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I am fully active or can carry out light work.
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I am not pregnant and can become pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort-Expansion Stage: Objective Response Rate (ORR)
Dose-Escalation Stage: MTD/recommended dose for XB002
Secondary outcome measures
Anti-tumor activity of XB002: Duration of Response (DOR)
Anti-tumor activity of XB002: Objective Response Rate (ORR)
Anti-tumor activity of XB002: Progression Free Survival (PFS)
+7 moreTrial Design
6Treatment 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.
Group V: XB002 + Bevacizumab Dose Expansion CohortsExperimental Treatment2 Interventions
The MTD or recommended dose from the dose-escalation stage may be further explored in subjects with epithelial ovarian cancer [EOC] (Cohort DB)
Group VI: XB002 + Bevacizumab Dose Escalation CohortsExperimental Treatment2 Interventions
Subjects (Cohort AB) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
ExelixisLead Sponsor
117 Previous Clinical Trials
18,978 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain metastases have been treated and stable for over 4 weeks.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.I do not have any severe illnesses that are not under control.Your heart's electrical activity, called the QT interval, is longer than 480 milliseconds when measured on an ECG.My cancer is confirmed, cannot be removed by surgery, and has spread or come back.I have not had major surgery in the last 4 weeks.My organs and bone marrow are working well.You have a disease that can be measured according to specific guidelines.I am not pregnant and can become pregnant.My side effects from previous treatments are mild or gone.I haven't had any cancer besides non-serious skin cancer or low-grade tumors considered cured in the last 2 years.My cancer has worsened despite my last treatment.I have tried or cannot tolerate standard treatments for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: XB002 Single-Agent Dose-Escalation Cohorts
- Group 2: XB002 Single-Agent Expansion Cohorts
- Group 3: XB002 + Nivolumab Dose Escalation Cohorts
- Group 4: XB002 + Nivolumab Dose Expansion Cohorts
- Group 5: XB002 + Bevacizumab Dose Escalation Cohorts
- Group 6: XB002 + Bevacizumab Dose Expansion Cohorts
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is XB002 for those under treatment?
"Due to the early phase status of this drug, XB002 receives a score of 1 for its safety profile. There is limited information related to efficacy and only preliminary data regarding safety."
Answered by AI
How many healthcare sites are currently operating this experiment?
"This trial has 5 active recruitment sites, including Site 1 in Austin,Site 3 in Nashville, and Site 5 located in Saint Louis. Additionally, there are two other medical centres conducting enrollment activities."
Answered by AI
Is participation in the trial still feasible?
"According to clinicaltrials.gov, this investigation into a new medical intervention is actively seeking volunteers for participation. The trial was first made public on June 7th 2021 and the details were last updated May 11th 2022."
Answered by AI
What are the paramount objectives of this investigation?
"In this 18-month clinical trial, the primary aim is to ascertain Objective Response Rate (ORR) in Cohort Expansion Stage. Secondary objectives include gauging XB002's Tolerability depending on dose intensity, Anti-tumor activity measured by Duration of Response (DOR), and ORR during Dose Escalation Stage per RECIST 1.1 Investigator or BIRC findings for chosen cohorts."
Answered by AI
Could you provide the aggregate figure of participants in this clinical experiment?
"To successfully complete this medical trial, 451 individuals must meet the required inclusion criteria. Participants can be sourced from a range of locations including Site 1 in Austin, Texas and Site 3 in Nashville, Tennessee."
Answered by AI
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