Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06240728

A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2

Led by NextPoint Therapeutics, Inc. · Updated on 2025-06-27

144

Participants Needed

8

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting B7-H7 (HHLA2) that may potentiate an anti-tumor immune response. The goal of this first-in-human study is to learn whether NPX887 is safe and tolerable and shows a preliminary efficacy in participants with B7-H7 (HHLA2) expressing tumors at selected dose(s). The main questions it aims to answer are: * what is an appropriate dose to be given to participants? * are the side effects of treatment manageable? * what is the preliminary anti-tumor activities? Participants who are treated will receive an intravenous (IV) infusion of NPX887 if their disease has not progressed, and be closely monitored by the treating physicians.

CONDITIONS

Official Title

A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to or intolerant of standard therapy in specified indications including NSCLC, SCLC, RCC, CRC, gastric and gastro-esophageal carcinoma, esophageal adenocarcinoma, biliary tract cancers, ovarian carcinoma, or other B7-H7/HHLA2 expressing solid tumors
  • Phase 1b participants must have confirmed B7-H7/HHLA2 expression in tumor via central lab testing
  • Evaluable disease by RECIST v1.1 (Phase 1a) or measurable disease with additional disease-specific criteria (Phase 1b)
  • ECOG performance status 0, 1, or 2
  • Ability and willingness to sign informed consent
  • Willingness to use highly effective contraception throughout the trial
Not Eligible

You will not qualify if you...

  • Systemic anticancer treatment within 14 days or 5 half-lives prior to first dose, whichever is shorter
  • Limited-field radiotherapy within 7 days or extended-field thoracic radiotherapy within 8 weeks prior to first dose
  • Unresolved toxicity of Grade 2 or higher from previous anticancer treatment, except alopecia, stable neuropathy >4 months, skin pigmentation changes, or endocrine replacement therapy
  • Known brain metastases unless clinically stable with no new or enlarging lesions at screening MRI
  • History of Grade 3 immune-related pneumonitis or colitis
  • Prior immunotherapy discontinuation due to immune-related toxicities or unresolved immune-related toxicities except for endocrine replacement therapy or vitiligo
  • Known autoimmune disease requiring immunosuppressive treatment equivalent to more than 10 mg prednisone daily

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21287

Active, Not Recruiting

2

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, United States, 02215

Active, Not Recruiting

3

Albert Einstein Medical College Montefiore Medical Center

The Bronx, New York, United States, 10461

Active, Not Recruiting

4

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Active, Not Recruiting

5

Next Oncology

San Antonio, Texas, United States, 78229

Active, Not Recruiting

6

NEXT Oncology-Fairfax

Fairfax, Virginia, United States, 22031

Active, Not Recruiting

7

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

8

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

T

Trials nextpointtx

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2 | DecenTrialz