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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
Must not have
Evidence of clinically significant immunosuppression such as the following: Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease (SCID), Concurrent opportunistic infection, Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (monthly or more frequently)
Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years.
Awards & highlights
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.
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.
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.
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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 a weak immune system due to conditions like SCID or frequent fluid build-ups needing drainage.
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I have had a bone marrow or organ transplant.
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I have a history of severe or ongoing infections.
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I have a history of heart problems.
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I have had lung inflammation or disease that caused symptoms.
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I have an active autoimmune disease or have been on high-dose steroids or immunosuppressants recently.
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I have a brain tumor or cancer that has spread to my brain.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-Finding
Dose-limiting Toxicity (DLT)
Frequency and Severity of Adverse Events (AE)
Secondary study objectives
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)
Find a Location
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.
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