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NM1F + Pembrolizumab for Advanced Breast Cancer
Phase 1
Recruiting
Research Sponsored by Hefei TG ImmunoPharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG PS of 0~2
Male or female subjects age ≥ 18 years at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years.
Awards & highlights
Study Summary
This trial tests a new drug to treat advanced cancer. It looks at safety, effectiveness, how it works in the body, and how it works with another drug.
Who is the study for?
This trial is for adults with advanced solid tumors, like colorectal or breast cancer, who've tried all standard treatments without success or can't tolerate them. They must be in a stable condition (ECOG PS 0~2), not pregnant, agree to use contraception, and have a life expectancy of at least 3 months.Check my eligibility
What is being tested?
The study tests NM1F alone and combined with Pembrolizumab on patients with advanced cancers. It's the first time humans are trying NM1F to see how safe it is, what side effects it has, and if it works against tumors.See study design
What are the potential side effects?
Possible side effects include reactions where the drug enters the body, tiredness, changes in blood test results that may show organ inflammation or immune system issues. Specific side effects will be monitored since this is a first-in-human study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-Finding
Dose-limiting Toxicity (DLT)
Frequency and Severity of Adverse Events (AE)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Number of subjects with Anti-NM1F antibody positive .
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NM1F Injection/pembrolizumab InjectionExperimental Treatment2 Interventions
NM1F monotherapy dose escalation(Phase 1a) NM1F dose escalation in combination with a fixed dose of pembrolizumab(Phase 1b)
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Who is running the clinical trial?
Hefei TG ImmunoPharma Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
123 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a weak immune system due to conditions like SCID or frequent fluid build-ups needing drainage.My cancer is advanced, has spread, and doesn't respond to standard treatments.I have had a bone marrow or organ transplant.I can take care of myself and am up and about more than half of my waking hours.I have a history of severe or ongoing infections.Women who can have babies must have a negative pregnancy test within 7 days before starting treatment.I have a history of heart problems.You must have at least one detectable tumor that can be measured using specific guidelines.I cannot use PD-1/PD-L1 inhibitors due to health reasons.I am 18 years old or older.I have had lung inflammation or disease that caused symptoms.I have an active autoimmune disease or have been on high-dose steroids or immunosuppressants recently.Criterion: You have received certain types of cancer treatments within specific time periods before starting this study. This includes treatments targeting specific immune system receptors, chemotherapy, targeted therapy, immunotherapy, or other cancer treatments. You also should not have received certain types of immunomodulatory drugs, live vaccines, or undergone major surgery within certain time frames before starting the study. Additionally, any significant side effects from previous treatments should have resolved.My organs are functioning well according to recent tests.I have not had active treatment for another cancer, except for certain skin or localized prostate cancers, in the last 3 years.You are expected to live for at least 3 more months.I have a brain tumor or cancer that has spread to my brain.
Research Study Groups:
This trial has the following groups:- Group 1: NM1F Injection/pembrolizumab Injection
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.
What is the current enrollment of participants in this research project?
"Affirmative. Per the clinicaltrials.gov listing, this trial is actively recruiting candidates since its posting on April 13th 2023 and was recently updated on May 16th 2023. 38 individuals are being sought out from two different medical sites for participation."
Answered by AI
Are there any participants being sought for this clinical trial at the moment?
"Evidently, this medical trial is recruiting patients as indicated on clinicaltrials.gov; the initial posting was April 13th 2023 and it has been updated lastly on May 16th 2023."
Answered by AI
What perils could potentially arise from the administration of NM1F Injection/pembrolizumab Injection?
"Given the limited data supporting both safety and efficacy, NM1F Injection/pembrolizumab injection achieved a score of 1 on our team's ranking system."
Answered by AI
What is the projected outcome from this research endeavor?
"This research, which is to be evaluated between the time of screening and 30 days after last dose, aims to identify Dose-limiting Toxicity (DLT). Secondary endpoints involve measuring Disease Control Rate (DCR), counting subjects with Anti-NM1F antibody positive levels, and determining Overall Survival (OS) for participants."
Answered by AI
Who else is applying?
What site did they apply to?
NEXT Oncology, Dallas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I’ve had limited results from traditional treatments.
PatientReceived no prior treatments
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