Recruiting
Phase 1

NPX372

Sponsor:

NextPoint Therapeutics, Inc.

Code:

NCT07563829

Conditions

Metastatic Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

NPX372

Study Details

Brief summary:

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.

Conditions

Metastatic Malignant Neoplasm

Study ID

NCT07563829

Start date

May 1, 2026

Status verified date

Sep, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

  • 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 CRITERIA:

  • 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).

Study Design

Enrollment

81 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

NPX372

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.

Primary outcome measure

  • Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: From first dose through 21 days ]
  • Overall incidence of Dose Limiting Equivalent Toxicity (DLET) during treatment [ Time Frame: From first dose up to 24 months ]
  • Incidence of AEs, characterized overall and by type, seriousness, relationship to NPX372, and severity. [ Time Frame: From first dose up to 24 months ]
  • 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 severity [ Time Frame: From first dose up to 24 months ]
  • Drug discontinuation, drug interruptions/delays and dose reductions due to treatment-related AEs [ Time Frame: From first dose up to 24 months ]
  • Number of participants with AEs, DLTs (inclusive of DLETs), and PD changes within blood [ Time Frame: From first dose up to 24 months ]

Central Contacts and Locations

Central contacts

Trials nextpointtx

(508) 214-1115trials@nextpointtx.com

Locations

University of California - San Diego

Recruiting

La Jolla, California, United States, 92093

Principal Investigator:

Sandip Patel, MD, Ph.D.

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Yasser Ged, MD, Ph.D.

Montefiore

Recruiting

The Bronx, New York, United States, 10461

Principal Investigator:

Haiyang Cheng, MD, Ph.D.

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Alicia Edge

615-329-7274alicia.edge@scri.com

Principal Investigator:

Melissa Johnson, MD, Ph.D.

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Aung Naing, MD

713 563-3885

NEXT

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Brianne Kaiser

210-580-9511bkaiser@nextoncology.com

Principal Investigator:

Alexander Spira, MD, Ph.D.

More Information

Sponsor

NextPoint Therapeutics, Inc.

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • solid tumor
  • B7-H7
  • bispecific antibody
  • dose escalation
  • CD3
  • HHLA2
  • T-cell engaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NextPoint Therapeutics, Inc. on 2026-09-08.