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

June 24, 2025 updated by: NextPoint Therapeutics, Inc.

A Phase 1a/1b, Dose-Escalation/Dose-Expansion Study of NPX267 in 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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

131

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10461
        • Albert Einstein Medical College Montefiore Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute Oncology Partners
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Next Oncology-San Antonio
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Oncology-Fairfax

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose limiting toxicity
Time Frame: from first dose through 21 days
Number of subjects with dose limiting toxicity
from first dose through 21 days
Incidence of treatment-emergent adverse events
Time Frame: up to 12 weeks from first dose
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
Time Frame: up to 12 weeks from first dose
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

Outcome Measure
Measure Description
Time Frame
Area under the concentration curve (AUC) of NPX267
Time Frame: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
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
Time Frame: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
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
Time Frame: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Overall survival
Time Frame: From first dose until death from any cause through 30 months
Average length of survival for treated patients
From first dose until death from any cause through 30 months
Immunogenicity of NPX267
Time Frame: From first dose through one year
Number of participants with anti-drug antibodies
From first dose through one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in biomarkers of activity
Time Frame: From first dose through one year
Exploratory analysis of biomarkers from collected tumor and blood samples
From first dose through one year

Collaborators and Investigators

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

Sponsor

NextPoint Therapeutics, Inc.

Investigators

  • Study Director: Leena Gandhi, MD, PhD, NextPoint

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 Major Dates

Study Start (Actual)

July 21, 2023

Primary Completion (Estimated)

September 20, 2025

Study Completion (Estimated)

September 20, 2025

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPX267-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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