NC762 for Solid Cancers

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: NextCure, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called NC762 to see if it can help treat patients with advanced or metastatic solid tumors.

Research Team

Han Myint, MD

Principal Investigator

NextCure, Inc.

Eligibility Criteria

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.

Inclusion 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.

Female subjects of childbearing potential and non-sterilized male subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy or fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug. Females of child-bearing potential must have a negative serum pregnancy test at screening

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Exclusion Criteria

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.

Your heart's QTc interval is longer than 470 milliseconds.

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Treatment Details

Interventions

NC762 (Other)

Trial OverviewThe 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.

Participant Groups

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