A Study Of NPX267 For Subjects With Solid Tumors Known To Express HHLA2/B7-H7

Study Overview

A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7

NPX267 is an antibody drug targeting the inhibitory receptor for B7-H7 (HHLA2) which may control evasion of the immune response in tumors. The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer. The main questions it aims to answer are: * what is an appropriate dose to be given to patients? * are the side effects of treatment manageable? Participants will be evaluated for participation in the study. Patients who are treated will receive an intravenous infusion of NPX267 every three weeks if their disease has not progressed. Patients will be closely monitored by the treating physician.

This trial is divided into two parts. The first part (dose escalation) will test different doses of drug to find a dose for part two. In the second part (dose expansion), more patients will be tested to see if the drug has an effect on patient's tumors. Throughout the study, data will be collected to characterize the clinical activity of the drug. Samples of blood will be taken to help in an understanding of how the drug behaves in the body by assessing the amount of drug in the blood over time (pharmacokinetics), and changes in blood components (pharmacodynamics and safety). Tumor imaging by computed tomography (CT) or magnetic resonance imaging (MRI) will be done about every nine weeks to assess NPX267 impact on tumor growth.

Metastatic Malignant Neoplasm

DRUG: NPX267

NPX267-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-06-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-24
First Submitted that Met QC Criteria 2023-07-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-27
First Posted (ACTUAL) 2023-07-24	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: NPX267 Treatment	DRUG: NPX267 NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: NPX267 Treatment

DRUG: NPX267

NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal

Primary Outcome Measures	Measure Description	Time Frame
Incidence of dose limiting toxicity	Number of subjects with dose limiting toxicity	from first dose through 21 days
Incidence of treatment-emergent adverse events	Number and type of adverse events categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	up to 12 weeks from first dose
Number of subjects with tumor response in tumors expressing B7-H7/HHLA2	The proportion of subjects with complete or partial responses or stable disease as defined by RECIST 1.1 criteria	up to 12 weeks from first dose

Secondary Outcome Measures	Measure Description	Time Frame
Area under the concentration curve (AUC) of NPX267	Measurement of plasma concentration over time for exposure to NPX267	Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Half-life in circulation (T1/2) of NPX267	Measurement of the clearance of NPX267 from plasma over time	Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Maximum plasma concentration (Cmax) of NPX267		Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Overall survival	Average length of survival for treated patients	From first dose until death from any cause through 30 months
Immunogenicity of NPX267	Number of participants with anti-drug antibodies	From first dose through one year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to standard of care therapy in one of the following indications: Part 1a: non-small cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), cholangiocarcinoma (CCA), pancreatic cancer (PDAC), urothelial carcinoma (UCC), gastric/gastroesophageal carcinoma, triple negative breast carcinoma, endometrial carcinoma, cervical cancer, osteosarcoma, and prostate cancer
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Normal bone marrow, kidney and liver function
Willing to use highly effective contraceptive measures throughout the trial

Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia, chronic neuropathy > 6 months, or changes in skin pigmentation
Have known or suspected brain metastases, unless they are clinically stable
Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily
History of grade 3 immune-related pneumonitis or colitis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Leena Gandhi, MD, PhD, NextPoint

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record