RECRUITING

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

Conditions

Colorectal Cancer Triple Negative Breast Cancer Gastric Cancer Ovarian Cancer navicixizumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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

Quick Facts

Study Start:2022-08-05

Study Completion:2024-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05453825

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient provides informed consent. 2. Patient is ≥18 years old. 3. 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 4. Patient has provided an FFPE archive or newly obtained core or excisional biopsy of a tumor lesion. 5. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Patient has measurable disease, as defined by RECIST v1.1. 7. Patient has adequate organ function. 8. Female patients of childbearing potential must have a negative pregnancy test. 9. 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. 10. 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. 11. Patient is willing and able to comply with scheduled visits and procedures. 12. Patient must have discontinued other anticancer interventions before Cycle 1 Day 1 per study protocol. 13. Patient has definitive pathologically confirmed adenocarcinoma of the colon or rectum. 14. Patient must have received at least 2 and no more than 3 prior lines of standard therapy for metastatic disease. 15. Patient has definitive pathologically confirmed metastatic gastric or GEJ adenocarcinoma that is not amenable to surgery. 16. Patient must have received only 1 prior line of standard therapy for metastatic disease. 17. Patient has definitive pathologically confirmed metastatic or locally advanced TNBC that is not amenable to surgery or radiotherapy with curative intent. 18. Patient must have received at least 2 prior and no more than 4 prior lines of standard therapy for metastatic disease. 19. Patient has definitive pathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer. 20. Patient must be considered platinum-resistant/refractory. 21. Patient must have received at least 2 and no more than 5 prior lines of standard therapy.	1. Patient has cardiac conditions as listed in the protocol. 2. Patient has blood pressure (BP) \>140/90 mmHg. 3. Patient is pregnant or lactating. 4. Patient has known untreated, active or uncontrolled brain metastases. 5. Patient with leptomeningeal disease. 6. Patient has a known additional malignancy that was progressing or required active treatment within 2 years prior to the first dose of study medication. 7. 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. 8. Patient has an active infection requiring IV systemic therapy. 9. 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. 10. Patient has a known clinically significant bleeding disorder. 11. 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. 12. Patient had hemoptysis \>2.5 mL within 8 weeks prior to C1D1 or serious bleeding from another site within this time frame. 13. Patient had a major surgical procedure, or significant traumatic injury within 28 days prior to C1D1. 14. Patient has an uncontrolled seizure disorder or active neurologic disease. 15. Patient has a cardiac aneurysm. 16. 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. 17. 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. 18. Patient has known microsatellite instability-high status. 19. Patient is on dialysis. 20. Patient has received hepatic intra-arterial chemotherapy. 21. Patient has experienced weight loss \>10% over 2 months prior to first dose of study treatment. 22. Patient has definitive pathologically confirmed HER2 positive metastatic gastric or GEJ adenocarcinoma. 23. Patient has pre-existing Grade ≥2 peripheral neuropathy, according to CTCAE v5.0. 24. Patient has pre-existing Grade ≥2 peripheral neuropathy, according to CTCAE v5.0. 25. Patient has non-epithelial ovarian carcinoma. 26. Patient has ovarian tumors with low malignant potential (ie, borderline tumors).

Inclusion Criteria

Exclusion Criteria

1. Patient provides informed consent.
2. Patient is ≥18 years old.
3. 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
4. Patient has provided an FFPE archive or newly obtained core or excisional biopsy of a tumor lesion.
5. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
6. Patient has measurable disease, as defined by RECIST v1.1.
7. Patient has adequate organ function.
8. Female patients of childbearing potential must have a negative pregnancy test.
9. 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.
10. 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.
11. Patient is willing and able to comply with scheduled visits and procedures.
12. Patient must have discontinued other anticancer interventions before Cycle 1 Day 1 per study protocol.
13. Patient has definitive pathologically confirmed adenocarcinoma of the colon or rectum.
14. Patient must have received at least 2 and no more than 3 prior lines of standard therapy for metastatic disease.
15. Patient has definitive pathologically confirmed metastatic gastric or GEJ adenocarcinoma that is not amenable to surgery.
16. Patient must have received only 1 prior line of standard therapy for metastatic disease.
17. Patient has definitive pathologically confirmed metastatic or locally advanced TNBC that is not amenable to surgery or radiotherapy with curative intent.
18. Patient must have received at least 2 prior and no more than 4 prior lines of standard therapy for metastatic disease.
19. Patient has definitive pathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.
20. Patient must be considered platinum-resistant/refractory.
21. Patient must have received at least 2 and no more than 5 prior lines of standard therapy.

1. Patient has cardiac conditions as listed in the protocol.
2. Patient has blood pressure (BP) \>140/90 mmHg.
3. Patient is pregnant or lactating.
4. Patient has known untreated, active or uncontrolled brain metastases.
5. Patient with leptomeningeal disease.
6. Patient has a known additional malignancy that was progressing or required active treatment within 2 years prior to the first dose of study medication.
7. 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.
8. Patient has an active infection requiring IV systemic therapy.
9. 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.
10. Patient has a known clinically significant bleeding disorder.
11. 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.
12. Patient had hemoptysis \>2.5 mL within 8 weeks prior to C1D1 or serious bleeding from another site within this time frame.
13. Patient had a major surgical procedure, or significant traumatic injury within 28 days prior to C1D1.
14. Patient has an uncontrolled seizure disorder or active neurologic disease.
15. Patient has a cardiac aneurysm.
16. 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.
17. 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.
18. Patient has known microsatellite instability-high status.
19. Patient is on dialysis.
20. Patient has received hepatic intra-arterial chemotherapy.
21. Patient has experienced weight loss \>10% over 2 months prior to first dose of study treatment.
22. Patient has definitive pathologically confirmed HER2 positive metastatic gastric or GEJ adenocarcinoma.
23. Patient has pre-existing Grade ≥2 peripheral neuropathy, according to CTCAE v5.0.
24. Patient has pre-existing Grade ≥2 peripheral neuropathy, according to CTCAE v5.0.
25. Patient has non-epithelial ovarian carcinoma.
26. Patient has ovarian tumors with low malignant potential (ie, borderline tumors).

Contacts and Locations

Study Contact

OncXerna Therapeutics

CONTACT

781-907-7810

medical@oncxerna.com

Study Locations (Sites)

Genesis Cancer Center

Hot Springs, Arkansas, 71913

United States

Keck Medicine of USC

Los Angeles, California, 90033

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Northside Hospital

Atlanta, Georgia, 30322

United States

Hematology Oncology Clinic

Baton Rouge, Louisiana, 70809

United States

New York University - Langone Health - Perlmutter Cancer Center

New York, New York, 10016

United States

The Zangmeister Cancer Center

Columbus, Ohio, 43219

United States

Tennessee Oncology

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: OncXerna Theraputics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-05

Study Completion Date2024-12-15

Study Record Updates

Study Start Date2022-08-05

Study Completion Date2024-12-15

Terms related to this study

Keywords Provided by Researchers

navicixizumab

Additional Relevant MeSH Terms

Colorectal Cancer
Triple Negative Breast Cancer
Gastric Cancer
Ovarian Cancer