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

Last updated: June 24, 2025
Sponsor: NextPoint Therapeutics, Inc.
Overall Status: Suspended

Phase

1

Condition

Neoplasms

Treatment

NPX267

Clinical Study ID

NCT05958199
NPX267-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed recurrent, metastatic solid tumorrefractory to standard of care therapy in one of the following indications: Part 1a:non-small cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), colorectalcarcinoma (CRC), cholangiocarcinoma (CCA), pancreatic cancer (PDAC), urothelialcarcinoma (UCC), gastric/gastroesophageal carcinoma, triple negative breastcarcinoma, 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

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 theequivalent of more than 10 mg prednisone daily

  • History of grade 3 immune-related pneumonitis or colitis

Study Design

Total Participants: 131
Treatment Group(s): 1
Primary Treatment: NPX267
Phase: 1
Study Start date:
July 21, 2023
Estimated Completion Date:
September 20, 2025

Study 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.

Connect with a study center

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Albert Einstein Medical College

    New York, New York 10461
    United States

    Active - Recruiting

  • Albert Einstein Medical College Montefiore Medical Center

    New York, New York 10461
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Oncology-San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • NEXT Oncology-Fairfax

    Fairfax, Virginia 22031
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.