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Monoclonal Antibodies

Navicixizumab Combinations for Advanced Breast Cancer

Phase 2

Recruiting

Research Sponsored by OncXerna Theraputics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has one of the following locally advanced or metastatic, unresectable solid malignancies that is incurable: CRC, Gastric or GEJ cancer, TNBC, Platinum-resistant/refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer

Patient has provided an FFPE archive or newly obtained core or excisional biopsy of a tumor lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18months

Awards & highlights

Study Summary

This trial is studying navicixizumab given alone or with paclitaxel or irinotecan in patients with advanced cancer.

Who is the study for?

This trial is for adults with certain advanced cancers (colorectal, gastric/GEJ, triple-negative breast, or platinum-resistant ovarian cancer) who've had specific numbers of prior treatments and can't have surgery. They must be able to follow the study plan, not be pregnant or breastfeeding, use contraception if needed, and have no serious health issues that could interfere.Check my eligibility

What is being tested?

The study tests navicixizumab alone or combined with paclitaxel or irinotecan in patients grouped by their cancer type. It aims to see how well these treatments work on different advanced solid tumors that are incurable with current methods.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system's response to the drugs which may affect organs; blood pressure changes; bleeding risks; gastrointestinal complications like bowel obstruction; fatigue from treatment; and potential nerve damage leading to sensory issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be surgically removed, and is one of the specified types.

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I have provided a biopsy sample of my tumor.

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I have gastric cancer and have only had one standard treatment for it when it was metastatic.

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I am a man and will use birth control during and for 6 months after the study.

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My cancer is a confirmed adenocarcinoma of the colon or rectum.

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My ovarian cancer does not respond to platinum-based chemotherapy.

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I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

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I have ovarian cancer and have had 2 to 5 standard treatments.

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I have triple-negative breast cancer and received 2-4 standard treatments for it.

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I am a woman who can have children and my pregnancy test is negative.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have colorectal cancer and have had 2-3 treatments for it after it spread.

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I have advanced stomach or GEJ cancer that cannot be removed by surgery.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR)

Progression Free Survival (PFS)

Secondary outcome measures

Adverse Events

Disease control rate (DCR)

Duration of Response (DOR)

+3 more

Other outcome measures

Cancer antigen-125 response

Immunogenicity

Navicixizumab Pharmacokinetics

Trial Design

3Treatment groups

Experimental Treatment

Group I: Navicixizumab monotherapyExperimental Treatment1 Intervention

CRC,TNBC and ovarian cancer patients will be assigned to this treatment arm.

Group II: Combination navicixizumab + paclitaxelExperimental Treatment1 Intervention

Gastric/GEJ and TNBC cancer patients will be assigned to this treatment arm.

Group III: Combination navicixizumab + irinotecanExperimental Treatment1 Intervention

CRC patients will be assigned to this treatment arm.

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

OncXerna Theraputics, Inc.Lead Sponsor

2 Previous Clinical Trials

480 Total Patients Enrolled

Media Library

Navicixizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05453825 — Phase 2

Breast Cancer Research Study Groups: Combination navicixizumab + paclitaxel, Navicixizumab monotherapy, Combination navicixizumab + irinotecan

Breast Cancer Clinical Trial 2023: Navicixizumab Highlights & Side Effects. Trial Name: NCT05453825 — Phase 2

Navicixizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05453825 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research protocol enrolling new subjects?

"Affirmative. Clinicaltrials.gov hosts information that suggests this clinical trial is still seeking participants, which it has been doing since 8th of May 2022. The research team needs to recruit 180 people from 7 different medical centres before the study's closure date on October 20th 2022."

Answered by AI

Has the FDA given authorization to administer navicixizumab as a single drug treatment?

"Navicixizumab monotherapy has been assigned a score of 2 based on the data from its phase two trial, which indicates some safety but no efficacy."

Answered by AI

What is the sample size of this investigation?

"To initiate this medical trial, 180 eligible individuals must be recruited. Individuals can volunteer to participate at the Hematology Oncology Clinic in Baton Rouge or Tennessee Oncology in Nashville."

Answered by AI

What is the primary aim of this experiment?

"This clinical trial has a 12-month duration, with the primary outcome being Overall Response Rate (ORR). Secondary endpoints comprise of Overall Survival (OS), Adverse Events assessed using Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) and Disease Control Rate (DCR). Clinical laboratory tests, vital sign measurements, ECGs, ECHOs and physical examinations are also employed to asses these outcomes."

Answered by AI

How prevalent is this investigation in the urban setting?

"Seven locations are offering this trial, including the Hematology Oncology Clinic in Baton Rouge, Tennessee Oncology in Nashville, and Genesis Cancer Center in Hot Springs. Additionally, there are four other sites around the country taking part."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Navicixizumab Monotherapy or in Combination in Patients With Select Advanced Solid Tumors

2022. "A Study of Navicixizumab Monotherapy or in Combination in Patients With Select Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05453825.

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