NPX372, a B7-H7:CD3 Bispecific Antibody, in Selected Solid Tumor Malignancies

Part of paid clinical trials in La Jolla, California.

Sponsor
NextPoint Therapeutics, Inc.
Study ID
NCT07563829
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Metastatic Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NPX372 — DRUG
    NPX372 is administered by IV infusion. The first cycle will be 3 weeks long and NPX372 will be given on the first day and one week later during this 3-week period. For most dose levels, the first day's dose (C1D1) will be a lower dose, which will serve as a "priming dose". The full dose will start on the second dose. After the first two doses, NPX372 will be administered every other week for up to 6 months. After that time, NPX372 will be given about once a month. Treatment may continue for up to 2 years as long as the patient is deriving benefit.

Study Details

NPX372 is an antibody drug (protein drug) that blocks a specific protein which is found to be increased on the surface of cancer cells called B7-H7 and, at the same time, binds to immune cells (T cells) through a receptor called CD3. The effect of this binding is to activate T cells to kill cancer cells with B7-H7. In this research study we are: * Evaluating the safety and possible effectiveness of NPX372. * Identifying a safe and tolerable dose or doses for further study. Participants who are treated will receive an intravenous (IV) infusion of NPX372 if their disease has not progressed, and be closely monitored by the treating physicians.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
81 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NPX372
    NPX372 is provided in single-use 5 mg vials at 1 mg per mL and is administered as an IV infusion over 60 minutes.

Primary Outcome Measure

Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: From first dose through 21 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California - San DiegoLa JollaCalifornia92093-
Johns HopkinsBaltimoreMaryland21287-
MontefioreThe BronxNew York10461-
Sarah Cannon Research InstituteNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
NEXTFairfaxVirginia22031-

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