Study on Navicixizumab Alone or Combined with Other Treatments for Advanced Solid Tumors

Sponsor: OncXerna Theraputics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05453825

Provider View

This clinical trial is exploring the use of navicixizumab, either by itself or with other cancer drugs, in patients with certain advanced cancers. The study includes patients with colorectal, gastric, triple-negative breast, and certain ovarian cancers.

Patient Parameters

Program Overview

The study aims to test the effectiveness and safety of navicixizumab, a new cancer treatment, either alone or combined with other drugs like paclitaxel or irinotecan. Patients with advanced cancers, such as colorectal cancer (CRC), gastric and gastroesophageal junction (GEJ) cancer, triple-negative breast cancer (TNBC), and certain types of ovarian cancer, will be grouped into different cohorts based on their cancer type. The treatment will be given in cycles, and patients will be monitored through regular check-ups, heart tests, and scans to track the progress of their tumors.

Description

After completing initial tests and providing a tissue sample, eligible patients will be assigned to receive navicixizumab alone or with another cancer drug, depending on their type of cancer and the available study group. Treatment is given in 4-week cycles, and patients will have regular visits to monitor their heart health and blood pressure. Tumors will be checked with CT scans. Patients who benefit from the treatment can continue until their cancer worsens, they experience severe side effects, their doctor advises stopping, or they choose to leave the study. After stopping treatment, patients will have follow-up visits or calls to check their health and any new cancer treatments they start.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent.

  • Must be 18 years or older.

  • Must have advanced or metastatic cancer that cannot be cured, including:

    • Colorectal cancer (CRC)
    • Gastric or GEJ cancer
    • Triple-negative breast cancer (TNBC)
    • Platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer

  • Must provide a tumor sample.

  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

  • Must have measurable disease based on standard criteria.

  • Must have adequate organ function.

  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 6 months after treatment.

  • Men with female partners of childbearing potential must agree to use contraception during and for 6 months after treatment.

  • Must be willing to attend scheduled visits and procedures.

  • Must have stopped other cancer treatments before starting the study.

    For CRC patients:

  • Must have confirmed adenocarcinoma of the colon or rectum.

  • Must have had 2 to 3 prior treatments for metastatic disease.

    For Gastric/GEJ cancer patients:

  • Must have confirmed metastatic gastric or GEJ adenocarcinoma not treatable by surgery.

  • Must have had 1 prior treatment for metastatic disease.

    For TNBC patients:

  • Must have confirmed metastatic or locally advanced TNBC not treatable by surgery or radiotherapy.

  • Must have had 2 to 4 prior treatments for metastatic disease.

    For Ovarian cancer patients:

  • Must have confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.

  • Must be considered platinum-resistant.

  • Must have had 2 to 5 prior treatments.

Exclusion Criteria

  • Have certain heart conditions.

  • Have high blood pressure over 140/90 mmHg.

  • Are pregnant or breastfeeding.

  • Have untreated or uncontrolled brain cancer spread.

  • Have leptomeningeal disease (cancer spread to the brain's lining).

  • Have another progressing cancer needing treatment within the last 2 years.

  • Have a history of bowel obstruction or related issues.

  • Have an active infection needing IV treatment.

  • Have allergies to study drugs.

  • Have a bleeding disorder.

  • Are using blood thinners without a stable dose.

  • Have had significant bleeding recently.

  • Have had major surgery or injury recently.

  • Have uncontrolled seizures or active neurological disease.

  • Have a heart aneurysm.

  • Have psychiatric or substance abuse issues affecting study participation.

  • Have any condition that may interfere with the study.

    For CRC patients:

  • Have high microsatellite instability.

    For CRC patients receiving navicixizumab + irinotecan:

  • Are on dialysis.

  • Have had liver-directed chemotherapy.

    For Gastric/GEJ cancer patients:

  • Have lost more than 10% body weight recently.

  • Have HER2 positive gastric or GEJ cancer.

  • Have severe nerve damage.

    For TNBC patients receiving navicixizumab + paclitaxel:

  • Have severe nerve damage.

    For Ovarian cancer patients:

  • Have non-epithelial ovarian cancer.

  • Have low malignant potential ovarian tumors.

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