What is the mechanism of action of this treatment?

Cervical cancer treatments often involve a combination of surgery, radiation therapy, and chemotherapy. Surgery, such as hysterectomy, physically removes cancerous tissues. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors. Chemotherapy employs drugs to target and destroy rapidly dividing cancer cells. Additionally, targeted therapies and immunotherapies, like those being studied in the trial XB002, focus on specific molecules or pathways involved in cancer growth. These treatments are crucial for cervical cancer patients as they offer multiple approaches to eliminate cancer cells, reduce tumor size, and prevent recurrence, thereby improving survival rates and quality of life.

What side effects are associated with this type of intervention?

Common treatments for cervical cancer, such as chemotherapy and radiation therapy, often come with side effects including nausea, vomiting, fatigue, and hair loss. Radiation therapy can also cause skin irritation, diarrhea, and bladder issues. Targeted therapies, like those involving bevacizumab, may lead to hypertension, bleeding, and gastrointestinal perforations. Immunotherapies, such as nivolumab, can cause immune-related adverse effects like colitis, pneumonitis, and hepatitis. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cervical cancer, including bevacizumab (Avastin), which is an angiogenesis inhibitor used in combination with chemotherapy for persistent, recurrent, or metastatic cervical cancer. Pembrolizumab (Keytruda), an immune checkpoint inhibitor targeting PD-1, has also been approved for advanced cervical cancer with disease progression during or after chemotherapy. These treatments, which involve targeted and immunotherapeutic approaches, may share similarities with the investigational drug XB002 being studied in clinical trials.

What other types of research exist?

Promising novel alternatives for cervical cancer treatment in 2024 include: <ol> <li>Hydroxyurea: Known for its efficacy in reducing complications in sickle cell disease, it may have potential applications in cancer therapy due to its ability to modify disease pathogenesis.</li> <li></li> </ol> ABBV-744: A selective inhibitor of the second bromodomain of BET family proteins, showing robust antitumor activity in preclinical models of acute myeloid leukemia, and potentially applicable to other cancers. 3. Combination therapies targeting c-MET and PARP: Such as NU1025 plus SU11274, which have shown reduced tumor growth and induced apoptosis in gastric cancer models, and may be explored for cervical cancer. 4. 19-(Benzyloxy)-19-oxojolkinolide B (19-BJB): Demonstrated potential in inhibiting tumor growth in bladder cancer models through DNA damage, which could be relevant for cervical cancer treatment.

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Monoclonal Antibodies

XB002 for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by Exelixis

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

Must not have

Uncontrolled, significant intercurrent or recent illness

Major surgery within 4 weeks before first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

Summary

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort-Expansion Stage: Objective Response Rate (ORR)

Dose-Escalation Stage: MTD/recommended dose for XB002

Secondary study objectives

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 more

Trial 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

~5540

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cervical cancer treatments often involve a combination of surgery, radiation therapy, and chemotherapy. Surgery, such as hysterectomy, physically removes cancerous tissues. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors. Chemotherapy employs drugs to target and destroy rapidly dividing cancer cells. Additionally, targeted therapies and immunotherapies, like those being studied in the trial XB002, focus on specific molecules or pathways involved in cancer growth. These treatments are crucial for cervical cancer patients as they offer multiple approaches to eliminate cancer cells, reduce tumor size, and prevent recurrence, thereby improving survival rates and quality of life.

Hallmarks of HPV carcinogenesis: The role of E6, E7 and E5 oncoproteins in cellular malignancy.