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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 months
Awards & highlights
Study Summary
This trial is testing a new drug, NC762, to see if it can shrink 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Define a maximum tolerated dose (MTD) or pharmacologically active dose (PAD)
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Secondary outcome measures
Disease Control Rate per RECIST
Downregulation of B7-H4 expression and changes in tumor infiltrating lymphocytes
Duration of Response per RECIST
+2 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: NC762 5mg/kgExperimental Treatment1 Intervention
Phase 1 Dose Escalation (Cohort 3): Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group II: NC762 20mg/kgExperimental Treatment1 Intervention
Phase 1 Dose Escalation (Cohort 5): Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group III: NC762 10mg/kgExperimental Treatment1 Intervention
Phase 1 Dose Escalation (Cohort 4): Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group IV: NC762 1.5mg/kgExperimental Treatment1 Intervention
Phase 1 Dose Escalation (Cohort 2): Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Group V: NC762 0.5mg/kgExperimental Treatment1 Intervention
Phase 1 Dose Escalation (Cohort 1): Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
Find a Location
Who is running the clinical trial?
NextCure, Inc.Lead Sponsor
6 Previous Clinical Trials
508 Total Patients Enrolled
Han Myint, MDStudy DirectorNextCure, Inc.
4 Previous Clinical Trials
349 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: NC762 0.5mg/kg
- Group 2: NC762 1.5mg/kg
- Group 3: NC762 5mg/kg
- Group 4: NC762 10mg/kg
- Group 5: NC762 20mg/kg
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.
How many locations within this state are executing this experiment?
"This clinical research is being conducted at Gettysburg Cancer Center in Gettysburg, Connecticut; Yale Cancer Center in New Haven, New york; and Roswell Park Cancer Institute in Buffalo, North carolina with 7 other sites participating."
Answered by AI
What is the scope of participants for this medical research?
"The trial necessitates 170 participants that comply with the enrolment requirements. Gettysburg Cancer Center in Gettysburg, Connecticut and Yale Cancer Centerin New Haven, New york are two sites offering this clinical opportunity."
Answered by AI
Are there any vacancies for participants in this investigation?
"Affirmative. According to the clinicaltrials.gov website, recruitment for this trial is ongoing since its initial posting on June 30th 2021; it was last updated on June 22nd 2022. Seeking 170 participants in total across seven distinct medical facilities."
Answered by AI
What are the researchers hoping to learn from this clinical experiment?
"This 28-day clinical trial will primarily monitor the number of patients experiencing adverse events. Secondary measures include objective response rate per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 and modified RECIST(mRECIST) v1.1, downregulation of B7-H4 expression, changes in tumour infiltrating lymphocytes after NC762 treatment, as well as duration of response per RECIST version 1.1 and mRECTS version 1."
Answered by AI
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