Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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