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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
Must not have
Patient has known untreated, active or uncontrolled brain metastases
Cohort C2 - TNBC (navicixizumab + paclitaxel) only: Patient has pre-existing Grade ≥2 peripheral neuropathy, according to CTCAE v5.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18months
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
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.
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.
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 belowSelect...
My cancer is advanced, cannot be surgically removed, and is one of the specified types.
Select...
I have provided a biopsy sample of my tumor.
Select...
I have gastric cancer and have only had one standard treatment for it when it was metastatic.
Select...
I am a man and will use birth control during and for 6 months after the study.
Select...
My cancer is a confirmed adenocarcinoma of the colon or rectum.
Select...
My ovarian cancer does not respond to platinum-based chemotherapy.
Select...
I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.
Select...
I have ovarian cancer and have had 2 to 5 standard treatments.
Select...
I have triple-negative breast cancer and received 2-4 standard treatments for it.
Select...
I am a woman who can have children and my pregnancy test is negative.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have colorectal cancer and have had 2-3 treatments for it after it spread.
Select...
I have advanced stomach or GEJ cancer that cannot be removed by surgery.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have untreated brain metastases that are not under control.
Select...
I have significant nerve damage in my hands or feet.
Select...
I have had bowel blockages or serious gut issues due to my illness.
Select...
I am currently receiving IV treatment for an infection.
Select...
My cancer is HER2 positive and located in my stomach or gastroesophageal junction.
Select...
I have lost more than 10% of my weight in the last 2 months due to my stomach cancer.
Select...
I have a cardiac aneurysm.
Select...
I have cancer that has spread to the lining of my brain and spinal cord.
Select...
I have heart conditions listed in the study details.
Select...
I have a type of ovarian cancer that is not the common surface-layer type.
Select...
I have ovarian cancer with tumors considered to be low in malignant potential.
Select...
I have seizures or a brain condition that is not under control.
Select...
I have severe nerve damage due to my gastric or GEJ cancer.
Select...
I have a bleeding disorder that affects my daily life.
Select...
I had major surgery or a significant injury within the last 28 days.
Select...
I have coughed up more than a teaspoon of blood or had serious bleeding recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Progression Free Survival (PFS)
Secondary study objectives
Adverse Events
Disease control rate (DCR)
Duration of Response (DOR)
+3 moreOther study objectives
Cancer antigen-125 response
Immunogenicity
Navicixizumab Pharmacokinetics
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Who is running the clinical trial?
OncXerna Theraputics, Inc.Lead Sponsor
2 Previous Clinical Trials
480 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on dialysis and interested in the CRC treatment with navicixizumab + irinotecan.My cancer is advanced, cannot be surgically removed, and is one of the specified types.Your blood pressure is higher than 140/90 mmHg.I have untreated brain metastases that are not under control.I have significant nerve damage in my hands or feet.I have provided a biopsy sample of my tumor.I have gastric cancer and have only had one standard treatment for it when it was metastatic.I have had bowel blockages or serious gut issues due to my illness.I am currently receiving IV treatment for an infection.I am allergic to some ingredients in the study medication.My cancer is HER2 positive and located in my stomach or gastroesophageal junction.My cancer is a confirmed adenocarcinoma of the colon or rectum.My organs are functioning well.My breast cancer is advanced or has spread, and cannot be removed by surgery or cured with radiation.I agree to use effective birth control during and for 6 months after the study.I am a man and will use birth control during and for 6 months after the study.My ovarian cancer does not respond to platinum-based chemotherapy.I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.I have ovarian cancer and have had 2 to 5 standard treatments.I have triple-negative breast cancer and received 2-4 standard treatments for it.I have had chemotherapy delivered directly to my liver.I have lost more than 10% of my weight in the last 2 months due to my stomach cancer.I have a cardiac aneurysm.I am a woman who can have children and my pregnancy test is negative.I have cancer that has spread to the lining of my brain and spinal cord.I am fully active or restricted in physically strenuous activity but can do light work.I have heart conditions listed in the study details.I have a type of ovarian cancer that is not the common surface-layer type.I have ovarian cancer with tumors considered to be low in malignant potential.I have colorectal cancer and have had 2-3 treatments for it after it spread.I have seizures or a brain condition that is not under control.I have severe nerve damage due to my gastric or GEJ cancer.I have advanced stomach or GEJ cancer that cannot be removed by surgery.I have a bleeding disorder that affects my daily life.I had major surgery or a significant injury within the last 28 days.I am 18 years old or older.I have coughed up more than a teaspoon of blood or had serious bleeding recently.You have a condition that can be measured according to specific guidelines.My colorectal cancer is MSI-High.I am on blood thinners or clot-dissolving drugs that haven't had a stable dose for over 14 days.I have another cancer that needed treatment in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Combination navicixizumab + paclitaxel
- Group 2: Navicixizumab monotherapy
- Group 3: Combination navicixizumab + irinotecan
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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