Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent
ECOG performance status 0 to 1
Must not have
Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 7 days before the first administration of study drug
Documented known activating or driver mutations which have not been previously treated with a standard of care targeted therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called NC762 to see if it can help treat patients with advanced or metastatic solid tumors.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including breast, ovarian, and non-small cell lung cancer. Participants must have progressed after standard treatments or be unable to tolerate them. They should not be candidates for curative surgery and must agree to avoid pregnancy. People with certain blood disorders, untreated mutations, active infections, recent transfusions or immunotherapies are excluded.
What is being tested?
The study is testing NC762's safety and effectiveness in treating various advanced cancers. It involves multiple phases: initial dose escalation to determine safe levels followed by expansion to assess safety further and a phase focused on efficacy.
What are the potential side effects?
While specific side effects of NC762 aren't listed here, common ones from similar cancer drugs include fatigue, nausea, diarrhea, liver issues (like elevated enzymes), skin reactions at the injection site and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread and cannot be surgically removed with the aim of curing it.
Select...
I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't received blood products or specific medications to stimulate blood cell production within the last 7 days.
Select...
My cancer has a specific mutation that hasn't been treated with targeted therapy.
Select...
I have a known history of HIV.
Select...
My kidney function is below the normal range.
Select...
I still have side effects from previous cancer treatments that are not mild.
Select...
I have an infection that hasn't improved with treatment.
Select...
My cancer has spread to my brain or its coverings.
Select...
I have lung inflammation not caused by an infection or a history of lung disease.
Select...
I do not have another cancer that is getting worse or needs treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Secondary study objectives
Area Under the Curve (AUC) of NC762
Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: 5mg/kg NC762Experimental Treatment1 Intervention
Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group II: 20mg/kg NC762Experimental Treatment1 Intervention
Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group III: 10mg/kg NC762Experimental Treatment1 Intervention
Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group IV: 1.5mg/kg NC762Experimental Treatment1 Intervention
Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group V: 0.5mg/kg NC762Experimental Treatment1 Intervention
Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors, such as targeted therapies and immunotherapies, work by specifically attacking cancer cells or enhancing the body's immune response. Targeted therapies focus on specific genetic mutations or proteins in cancer cells, minimizing damage to normal cells.
Immunotherapies boost the immune system's ability to recognize and destroy cancer cells. These approaches are important for patients with solid tumors as they provide more personalized and potentially more effective treatment options compared to traditional chemotherapy.
Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.
Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.
Find a Location
Who is running the clinical trial?
NextCure, Inc.Lead Sponsor
6 Previous Clinical Trials
586 Total Patients Enrolled
Han Myint, MDStudy DirectorNextCure, Inc.
4 Previous Clinical Trials
427 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has worsened after treatment, or I cannot tolerate or refuse standard treatments.I am willing to have tumor biopsies before and during treatment.Your liver enzymes are too high, unless you have documented liver or bone spread of cancer, in which case they can be a little higher.You have a condition where your immune system attacks your own body and needed strong medicine to treat it in the past.My cancer has spread and cannot be surgically removed with the aim of curing it.Your heart's QTc interval is longer than 470 milliseconds.I haven't received blood products or specific medications to stimulate blood cell production within the last 7 days.My cancer can be measured and has grown in previously treated areas.I am fully active or can carry out light work.I am 18 years old or older.Your blood platelet count is less than 100,000.My blood clotting tests are higher than normal, but I might be on blood thinners.My cancer has a specific mutation that hasn't been treated with targeted therapy.I have a known history of HIV.Your body has too few infection-fighting white blood cells.My kidney function is below the normal range.Your hemoglobin level is lower than 9 g/dL or 5.6 mmol/L.I still have side effects from previous cancer treatments that are not mild.Your total bilirubin level is higher than 1.5 times the upper limit of normal.I have an infection that hasn't improved with treatment.My cancer has spread to my brain or its coverings.I have lung inflammation not caused by an infection or a history of lung disease.I do not have another cancer that is getting worse or needs treatment.I haven't taken any cancer drugs or experimental medications recently.I have not received a live vaccine in the last 30 days.You have hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured.
Research Study Groups:
This trial has the following groups:- Group 1: 1.5mg/kg NC762
- Group 2: 20mg/kg NC762
- Group 3: 5mg/kg NC762
- Group 4: 10mg/kg NC762
- Group 5: 0.5mg/kg NC762
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.
Share this study with friends
Copy Link
Messenger