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Monoclonal Antibodies
NPX267 for Cancer
Phase 1
Recruiting
Research Sponsored by NextPoint Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose through one year
Awards & highlights
Study Summary
This trial aims to see if NPX267, an antibody drug, is safe & tolerable in cancer patients & what the right dose is. Patients are closely monitored & receive infusions every 3 wks if their disease hasn't progressed.
Who is the study for?
This trial is for adults with certain advanced cancers, like lung or breast cancer, that no longer respond to standard treatments. They must be fairly active (ECOG status 0 or 1), have normal organ function, and agree to use effective birth control. People can't join if they're on high-dose steroids for autoimmune diseases, have unstable brain tumors, severe lingering side effects from past cancer treatments (except hair loss or long-term nerve pain/skin color changes), or a history of serious immune-related lung/intestine problems.Check my eligibility
What is being tested?
NPX267 is being tested in this study. It's an antibody drug given by IV every three weeks aimed at helping the body's immune system recognize and fight cancer cells expressing HHLA2 protein. The study will determine the right dose and assess how patients handle the treatment regarding safety and tolerability.See study design
What are the potential side effects?
Potential side effects of NPX267 may include reactions related to strengthening the immune system against cancer which could affect various organs leading to inflammation-like symptoms; however, specific side effect profiles will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose through one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose through one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicity
Incidence of treatment-emergent adverse events
Number of subjects with tumor response in tumors expressing HHLA2
Secondary outcome measures
Area under the concentration curve (AUC) of NPX267
Half-life in circulation (T1/2) of NPX267
Immunogenicity of NPX267
+2 moreOther outcome measures
Change in biomarkers of activity
Trial Design
1Treatment groups
Experimental Treatment
Group I: NPX267 TreatmentExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
NextPoint Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
144 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow, kidney, and liver are functioning normally.My brain metastases are stable and not causing symptoms.I am fully active or can carry out light work.I have had severe lung or colon inflammation due to immune system reactions.My cancer is one of the listed types and has not responded to standard treatments.I don't have lasting side effects from cancer treatment, except for hair loss, long-term nerve damage, or skin color changes.I take more than 10 mg of prednisone daily for an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: NPX267 Treatment
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the NPX267 Treatment been authorized by the FDA?
"Even though there is limited evidence to support NPX267 Treatment's safety and efficacy, we have assigned a score of 1 based on our internal assessment."
Answered by AI
How many locations in Canada are currently conducting this research?
"A handful of sites are running this medical trial, including Massachusetts General Hospital in Boston, Albert Einstein Medical College in New york and Sarah Cannon Research Institute in Nashville. There are 3 other locations involved too."
Answered by AI
Is this research study recruiting participants at present?
"Per information on clinicaltrials.gov, this research project is not presently recruiting participants. This trial was first shared on July 1st of 2023 and has been revised as recently as the 14th of that same month; however, there are 2,533 other trials searching for volunteers right now."
Answered by AI
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