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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
No Placebo-Only Group

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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years. for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab injection
2023
Completed Phase 1
~60

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

NM1F Injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05746897 — Phase 1
Breast Cancer Research Study Groups: NM1F Injection/pembrolizumab Injection
Breast Cancer Clinical Trial 2023: NM1F Injection Highlights & Side Effects. Trial Name: NCT05746897 — Phase 1
NM1F Injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746897 — Phase 1
~24 spots leftby Sep 2027
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