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

{ "NPX372 for Advanced Solid Tumors", "This study is testing a new antibody drug called NPX372 for people with advanced solid tumors that have not responded to standard treatments. NPX372 works by targeting a protein called B7-H7 on cancer cells and also activating your immune cells (T cells) to help them fight the cancer. We are looking at how safe NPX372 is, what side effects it might cause, and if it shows any signs of helping to treat the cancer. The study will also help us find the best dose of NPX372 for future research. You would receive NPX372 through an IV infusion, with close monitoring by doctors. This study is for adults aged 19 and older with specific types of metastatic (spread) solid tumors.", "design": "This is an interventional study planning to enroll 81 participants. It is a Phase 1 study focused on finding a safe and tolerable dose of NPX372.", "commitments": "You would receive NPX372 through an IV infusion. The first cycle is 3 weeks long, with doses given on day 1 and one week later. You will be closely monitored by treating physicians.", "compensation": "Not stated in the trial record.", "follow_up": "You will be monitored for side effects and dose-limiting toxicities for up to 24 months after your first dose.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Not Yet Recruiting

PHASE1Ages 19+InterventionalTreatment

NextPoint Therapeutics, Inc.

~81 participants

Updated 2026-05-04 on ClinicalTrials.gov

What's tested:NPX372

At a glance

Recruiting sites

0 of 6 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of Dose Limiting Toxicity (DLT)

Measured over From first dose through 21 days

+5 more outcomes measured

Conditions

Metastatic Malignant Neoplasm

Where it's being run

6 sites across 6 states

California1

Maryland1

New York1

Tennessee1

Texas1

Virginia1

Study leadership

Leena Gandhi, MD, Ph.D. · STUDY_DIRECTOR · NextPoint Therapeutics, Inc.

Who to contact

Trials nextpointtx

[email protected]

(508) 214-1115

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ability to understand and the willingness to sign a written informed consent document.

Histologically or cytologically confirmed recurrent or metastatic solid tumor refractory to standard of care therapy in one of the following indications: NSCLC, RCC, CRC, PDAC, biliary tract tumors, gastric and gastro-esophageal carcinoma, and ovarian carcinoma.

Measurable disease by RECIST v1.1 criteria.

Age ≥19 years.

Adequate organ function as defined by:

Calculated creatinine clearance (CrCl) must be ≥45 mL/min (by Cockroft-Gault formula).

Total bilirubin ≤1.5× the upper limit of normal (ULN) unless prior history of Gilbert's syndrome who must have total bilirubin \<3.0 mg/dL.

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN, or ≤5× ULN if due to liver involvement by tumor.

Serum albumin ≥3.0 g/dL.

Hemoglobin ≥9.0 g/dL, limited transfusion to reach this value may be allowed after discussion with the Sponsor's Medical Monitor.

Platelets ≥100 × 109 cells/L.

Absolute neutrophil count ≥1.5 ×109 cells/L.

Baseline oxygen saturation \> 90% on room air

All participants will be required to have sufficient archival tissue available. For backfill cohort participants, archival tissue will be used to confirm B7-H7 expression for enrollment (see inclusion criterion 2) during pre-screening.

If 3 participants are already enrolled in any backfill cohort, subsequent participants will be required to have a fresh biopsy during the screening period. These participants should therefore only be selected if judged safe to undergo a fresh biopsy.

Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 60 days after the last dose of study drug is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.

Exclusion

Prior treatment toxicity not resolved to grade 1 or below including any:

Systemic anti-cancer treatment: exceptions include alopecia, chronic stable neuropathy for \>4 months, change in skin pigmentation, grade 2 anemia, or requiring replacement therapy for endocrine abnormalities (in this setting, symptoms should have resolved to grade 1 or below). Systemic anti-cancer treatment within 10 days prior to start of study is not allowed.

Limited-field radiotherapy: radiation therapy within 7 days prior to start of study or extended-field thoracic radiotherapy within 8 weeks of the first dose of study drug is not allowed.

Major surgery: major surgery (excluding placement of catheters, vascular access, or biopsy) within 4 weeks of the first dose of study drug is not allowed.

Clinically or radiographically unstable brain metastases: Participants with known brain metastases should be clinically stable and asymptomatic. Participants with a history of brain metastases should have an MRI during screening. For participants who are noted to have new or enlarging brain metastases during screening, treatment with stereotactic radiosurgery (SRS) is permitted with the standard limited field radiotherapy washout of \>7 days. Participants requiring more extensive radiation (ie, fractionated stereotactic radiation or whole-brain radiation) would need a washout period of ≥4 weeks. Participants should be off corticosteroids for central nervous system (CNS) treatment for at least 7 days prior to dosing.

Cardiac conditions as follows: history of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification; cardiac arrhythmias \>Grade 2, unstable angina, coronary/peripheral artery bypass graft within 3 months, or evidence of 2nd- or 3rd-degree heart block.

Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including hepatitis B virus \[HBV\], hepatitis C virus \[HCV\], human immunodeficiency virus \[HIV\] infections except as below, and active clinical tuberculosis), or renal transplant; ongoing or active infection, or social situations that would limit compliance with study requirements.

HIV: Seropositive participants without an acquired immunodeficiency syndrome (AIDS) defining illness and those with AIDS defining conditions on anti-retroviral therapy (ART) are eligible if they are healthy and have a CD4 count \>350 cells/mm3 at the time of screening (Day ≤28 days). Participants on ART must have HIV RNA levels \<50 copies/mL or the lower limit of quantification (LLOQ) using a local assay at the time of screening. Participants on ART must have been on a stable regimen without dose modification for at least 4 weeks prior screening.

HBV: Participants with HBsAg positivity are eligible if they have undetectable viral load and have received HBV anti-viral therapy for at least 4 weeks prior to screening.

HCV: Participants with a history of HCV infection are eligible if they have undetectable HCV viralload at screening and have completed curative therapy \>4 weeks prior to screening.

Any evidence of hemoptysis or gastrointestinal (GI) bleeding within the last 3 months prior to screening.

Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily.

History of unresolved prior immune-related toxicity except for endocrine abnormalities requiring replacement therapy or vitiligo.

Prior treatment with a cytokine therapy or cytokine fusion therapy.

History of prior or concomitant malignancy that requires other active treatment except for prostate cancer without radiographic evidence of disease on long-term androgen deprivation therapy for \>6 months (ie, leuprolide).

What this trial measures

Incidence of Dose Limiting Toxicity (DLT)From first dose through 21 days
Number of participants with DLT
Overall incidence of Dose Limiting Equivalent Toxicity (DLET) during treatmentFrom first dose up to 24 months
Number of participants with DLET
Incidence of AEs, characterized overall and by type, seriousness, relationship to NPX372, and severity.From first dose up to 24 months
Number and type of AEs categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Number of participants with abnormal laboratory parameters, vital signs, electrocardiogram (ECG) parameters, physical examination findings as characterized by type, frequency, timing, relationship to NPX372, and severityFrom first dose up to 24 months
Drug discontinuation, drug interruptions/delays and dose reductions due to treatment-related AEsFrom first dose up to 24 months
Number of participants with changes to their dosing schedule as a result of treatment-related AEs
Number of participants with AEs, DLTs (inclusive of DLETs), and PD changes within bloodFrom first dose up to 24 months

Trialytics