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Colorectal CancerPhase 2NCT05453825

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

A Phase 2 study testing navicixizumab+paclitaxel, navicixizumab+irinotecan and navicixizumab monotherapy in people with Colorectal Cancer and Triple Negative Breast Cancer, run by OncXerna Theraputics, Inc. at 8 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a study of navicixizumab monotherapy or in combination with paclitaxel or irinotecan in patients with advanced cancer. Patients will be enrolled into one of the following cancer cohorts: Cohort A: CRC Cohort B: Gastric and GEJ cancer Cohort C: TNBC Cohort D: Platinum-resistant/refractory epithelial ovarian… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
navicixizumab+paclitaxel, navicixizumab+irinotecan and navicixizumab monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
8 sitesUnited States
Study dates
5 Aug 2022to 15 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient provides informed consent.
  • Patient is ≥18 years old.
  • Patient has one of the following locally advanced or metastatic, unresectable solid malignancies that is incurable:
  • CRC
  • Gastric or GEJ cancer
  • TNBC
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  • 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.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Patient has measurable disease, as defined by RECIST v1.1.
  • Patient has adequate organ function.
  • Female patients of childbearing potential must have a negative pregnancy test.
  • Female patients of childbearing potential must agree to follow instructions for highly effective method(s) of contraception while receiving study treatment and for 6 months after the last dose of study drug.
  • Male patients with female sexual partners of childbearing potential must agree to use an acceptable form of contraception while receiving study treatment and for 6 months after the last dose of any study drug.
  • Patient is willing and able to comply with scheduled visits and procedures.
  • Patient must have discontinued other anticancer interventions before Cycle 1 Day 1 per study protocol.
  • Cohort A1 and Cohort A2 - CRC only:
  • Patient has definitive pathologically confirmed adenocarcinoma of the colon or rectum.
  • Patient must have received at least 2 and no more than 3 prior lines of standard therapy for metastatic disease.
  • Cohort B1 - Gastric/GEJ cancer only:
  • Patient has definitive pathologically confirmed metastatic gastric or GEJ adenocarcinoma that is not amenable to surgery.
  • Patient must have received only 1 prior line of standard therapy for metastatic disease.
  • Cohort C1 and Cohort C2 - TNBC only:
  • Patient has definitive pathologically confirmed metastatic or locally advanced TNBC that is not amenable to surgery or radiotherapy with curative intent.
  • Patient must have received at least 2 prior and no more than 4 prior lines of standard therapy for metastatic disease.
  • Cohort D1 - Ovarian cancer only:
  • Patient has definitive pathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Patient must be considered platinum-resistant/refractory.
  • Patient must have received at least 2 and no more than 5 prior lines of standard therapy.

Who cannot join

  • Patient has cardiac conditions as listed in the protocol.
  • Patient has blood pressure (BP) >140/90 mmHg.
  • Patient is pregnant or lactating.
  • Patient has known untreated, active or uncontrolled brain metastases.
  • Patient with leptomeningeal disease.
  • Patient has a known additional malignancy that was progressing or required active treatment within 2 years prior to the first dose of study medication.
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  • Patient has a history of bowel obstruction, including sub-occlusive disease, related to the underlying disease or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess.
  • Patient has an active infection requiring IV systemic therapy.
  • Patient has known hypersensitivity to any components of any study drug or any of its excipients that, in the opinion of the investigator, suggests a high risk for a severe hypersensitivity reaction while on treatment.
  • Patient has a known clinically significant bleeding disorder.
  • Patient is currently using oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes for which the dose has not been stable for >14 days prior to C1D1.
  • Patient had hemoptysis >2.5 mL within 8 weeks prior to C1D1 or serious bleeding from another site within this time frame.
  • Patient had a major surgical procedure, or significant traumatic injury within 28 days prior to C1D1.
  • Patient has an uncontrolled seizure disorder or active neurologic disease.
  • Patient has a cardiac aneurysm.
  • Patient has a known psychiatric disorder, substance abuse disorder, or geographical travel limitations that in the opinion of the investigator would interfere with patient's ability to cooperate with the requirements of the study.
  • Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that may confound the results of the study, interfere with the patient's participation for the full duration of the study, or indicates a condition for which study participation is not in the best interest of the patient, in the opinion of the investigator.
  • Cohort A1 and Cohort A2 - CRC only:
  • Patient has known microsatellite instability-high status.
  • Cohort A2 - CRC (navicixizumab + irinotecan) only:
  • Patient is on dialysis.
  • Patient has received hepatic intra-arterial chemotherapy.
  • Cohort B1 - Gastric/GEJ cancer only:
  • Patient has experienced weight loss >10% over 2 months prior to first dose of study treatment.
  • Patient has definitive pathologically confirmed HER2 positive metastatic gastric or GEJ adenocarcinoma.
  • Patient has pre-existing Grade ≥2 peripheral neuropathy, according to CTCAE v5.0.
  • Cohort C2 - TNBC (navicixizumab + paclitaxel) only
  • Patient has pre-existing Grade ≥2 peripheral neuropathy, according to CTCAE v5.0.
  • Cohort D1 - Ovarian cancer only:
  • Patient has non-epithelial ovarian carcinoma.
  • Patient has ovarian tumors with low malignant potential (ie, borderline tumors).

Trial locations and contacts

8 sites in 1 country.

OncXerna Therapeutics contact

781-907-7810

medical@oncxerna.com

8 sites in 1 country

United States8 sites, 8 recruiting

  • Northside Hospital

    Atlanta, Georgia, 30322

    Recruiting

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70809

    Recruiting

  • The Zangmeister Cancer Center

    Columbus, Ohio, 43219

    Recruiting

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

    Recruiting

  • Keck Medicine of USC

    Los Angeles, California, 90033

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Recruiting

  • New York University - Langone Health - Perlmutter Cancer Center

    New York, New York, 10016

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Open-Label Basket Study of Navicixizumab Monotherapy or in Combination With Paclitaxel or Irinotecan in Patients With Select Advanced Solid Tumors

This is a study of navicixizumab monotherapy or in combination with paclitaxel or irinotecan in patients with advanced cancer. Patients will be enrolled into one of the following cancer cohorts:

  • Cohort A: CRC
  • Cohort B: Gastric and GEJ cancer
  • Cohort C: TNBC
  • Cohort D: Platinum-resistant/refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer (ovarian cancer)
Read the detailed description

After completing all screening procedures, including the submission of a tissue sample, patients that meet eligibility requirements will be assigned to receive navicixizumab alone or in combination with another anticancer agent. Treatment is assigned based on the patients type of tumor and the cohort that is open at the time of enrollment. Patients will receive treatment in 4 week cycles, attend study visits and have their heart monitored through echocardiograms and daily blood pressure measurements. Patients will also have their tumors monitored regularly through CT scans. Patients receiving benefit may continue on study drug until their tumor progresses, they experience intolerable side effects, their physician decides it is in their best interest to discontinue therapy or they choose to withdrawal from the study. After discontinuing study treatments, all patients will receive regular follow up calls or visits to assess their status and other anticancer treatments they may start.

Being tested
navicixizumab+paclitaxel, navicixizumab+irinotecan, navicixizumab monotherapy
Keywords
navicixizumab
Medical subject headings
Colorectal Neoplasms, Triple Negative Breast Neoplasms, Stomach Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • navicixizumab+paclitaxelBiological

    navicixizumab 3 mg/kg Q2W; paclitaxel 80 mg/m2 weekly

  • navicixizumab+irinotecanBiological

    navicixizumab 3 mg/kg Q2W; irinotecan 180 mg/m2 Q2W

  • navicixizumab monotherapyBiological

    navicixizumab 3 mg/kg Q2W

Study groups in NCT05453825
Study groupRoleWhat they receive
Combination navicixizumab + paclitaxelExperimentalGastric/GEJ and TNBC cancer patients will be assigned to this treatment arm.
Receives: Biological: navicixizumab+paclitaxel
Combination navicixizumab + irinotecanExperimentalCRC patients will be assigned to this treatment arm.
Receives: Biological: navicixizumab+irinotecan
Navicixizumab monotherapyExperimentalCRC,TNBC and ovarian cancer patients will be assigned to this treatment arm.
Receives: Biological: navicixizumab monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    The proportion of patients with a confirmed best overall response (BOR) of complete response (CR) or PR by Response Evaluation Criteria in Solid Tumors, version 1.1 as determined by investigator tumor response assessments

    Measured: Up to 12 months

  2. Progression Free Survival (PFS)

    The time from first dose to the date of first documentation of objective disease progression or death (any cause), whichever occurs first, as determined by investigator tumor response assessments

    Measured: Up to 12 months

Secondary outcomes (6)

  1. Adverse Events

    Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0); clinical laboratory tests; vital sign measurements; electrocardiograms (ECGs); Doppler echocardiograms (ECHOs); physical examinations (PEs)

    Measured: Up to 12 months

  2. Overall Survival (OS

    Defined as the time from first dose to death

    Measured: Up to 18 months

  3. Time to Response (TTR)

    Defined as the time from first dose to first documentation of response (CR or PR)

    Measured: Up to 12 months

  4. Disease control rate (DCR)

    Defined as the proportion of patients with SD or a confirmed BOR of CR or PR

    Measured: Up to 12 months

  5. Duration of Response (DOR)

    Defined as the time from first documentation of response (CR or PR) to documentation of objective disease progression or death due to any cause, whichever occurs first

    Measured: Up to 18months

  6. Xerna™ TME biomarker

    Relationship between antitumor activity of navicixizumab therapy and Xerna™ TME Panel biomarker subtypes

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2022
  2. Study start5 Aug 2022
  3. Primary completion15 Apr 2024 (estimated)
  4. Study completion15 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05453825
Sponsor's protocol ID
ONCX-NAV-G201
Status last verified
Jan 2023
First submitted
7 Jul 2022
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing navicixizumab+paclitaxel, navicixizumab+irinotecan and navicixizumab monotherapy in people with Colorectal Cancer and Triple Negative Breast Cancer, run by OncXerna Theraputics, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact OncXerna Therapeutics (781-907-7810, medical@oncxerna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05453825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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Clinical Trial NCT05453825 | AzTrials