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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06240728
Recruitment Status : Recruiting
First Posted : February 5, 2024
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
NextPoint Therapeutics, Inc.

Study Description
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Brief Summary:

NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting HHLA2 (B7-H7) 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 in participants whose cancers are known to express HHLA2 (B7-H7).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?

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.


Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm Drug: NPX887 Phase 1

Detailed Description:

This study is comprised of Phase 1a (Dose Escalation) and Phase 1b (Dose Expansion). Phase 1a will test different doses of NPX887 to determine the optimal dose(s) to continue with in Phase 1b. In the Phase 1b, more participants will be tested to evaluate preliminary activity in multiple disease-specific cohorts and compare the efficacy of the higher and lower doses chosen in Phase 1a.

Throughout the study, data will be collected to characterize the clinical activity of NPX887. Samples of blood will be taken to help in an understanding of how NPX887 behaves in the body by assessing the amount of drug in the blood over time, and changes in blood components.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Dose escalation and dose expansion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Dose Escalation and Dose Expansion Study of NPX887 in Participants With Solid Tumor Malignancies Known to Express HHLA-2/B7-H7
Actual Study Start Date : January 22, 2024
Estimated Primary Completion Date : August 2027
Estimated Study Completion Date : August 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: NPX887 Treatment Drug: NPX887
NPX887 will be administered by IV infusion every 3 weeks until documented disease progression or participant withdrawal for up to 2 years


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose limiting toxicity (DLT) [ Time Frame: From first dose through 21 days ]
    Number of participants with DLT

  2. Incidence of treatment-emergent adverse events (AEs) [ Time Frame: Up to 24 months from first dose ]
    Number and type of AEs categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  3. Incidence of discontinuations, dosing interruptions, and dose reductions [ Time Frame: From first dose up to 24 months ]
    Number of participants with changes to their dosing schedule as a result of treatment-related AEs


Secondary Outcome Measures :
  1. Area under the concentration curve (AUC0-24) of NPX887 [ Time Frame: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 7, then on day 1 every 3 cycles, up to end of treatment and 90-day follow-up ]
    Measurement of plasma concentration over time for exposure to NPX887

  2. Maximum plasma concentration (Cmax) of NPX887 [ Time Frame: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 7, then on day 1 every 3 cycles, up to end of treatment and 90-day follow-up ]
    Measurement of plasma concentration over time for exposure to NPX887

  3. Half-life in blood circulation (T1/2) of NPX887 [ Time Frame: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 7, then on day 1 every 3 cycles, up to end of treatment and 90-day follow-up ]
    Measurement of the clearance of NPX887 from plasma over time

  4. Immunogenicity of NPX887 [ Time Frame: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 4, then on day 1 every 3 cycles, up to 90-day follow-up ]
    Number of participants with anti-drug antibodies (ADA)

  5. Overall survival (OS) [ Time Frame: From first dose until death from any cause through 24 months ]
    Average length of survival for treated participants


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to standard of care therapy in one of the following indications:

    • Phase 1a: Non-small cell lung carcinoma (NSCLC), small cell lung carcinoma (SCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), and other solid tumor types known to express HHLA2/B7-H7.
    • Phase 1b: participants who have clear cell RCC, lung adenocarcinoma, or CRC.
    • In Phase 1b, participants must have confirmed HHLA2/B7-H7 expression in their tumor.
  • Phase 1a: Evaluable disease (measurable or non-measurable) by RECIST v.1.1 criteria; Phase 1b: Measurable disease by RECIST v1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Ability to understand and the willingness to sign a written informed consent document
  • Willing to use highly effective contraceptive measures throughout the trial.

Exclusion Criteria:

  • Treatment with any of the following:

    • Systemic anticancer treatment <14 days prior to the first dose of study drug.
    • Limited-field radiotherapy <7 days or extended-field thoracic radiotherapy <8 weeks of the first dose of study drug.
  • History of Grade 3 immune-related pneumonitis or colitis.
  • Participants who discontinued prior immunotherapy due to immune-related toxicities, or history of unresolved prior immune-related toxicity except for endocrine abnormalities requiring replacement therapy or vitiligo.
  • Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06240728


Contacts
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Contact: Leena Gandhi, MD, PhD 857 209-0486 NPX887-001@nextpointtx.com
Contact: Michael O'Meara 617 512-0258 NPX887-001@nextpointtx.com

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Danielle Wendler    410-502-5140    dschul15@jhmi.edu   
United States, Massachusetts
Beth Israel Deaconess Medical Center (BIDMC) Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Kati Mack    617-975-7459    kmack3@bidmc.harvard.edu   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Aung Naing, MD    713-563-3885    anaing@mdanderson.org   
Next Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Brianna Flores    210-580-9521    bflores@nextoncology.com   
United States, Virginia
NEXT Oncology-Fairfax Recruiting
Fairfax, Virginia, United States, 22031
Contact: Blake Patterson    703-783-4505    bpatterson@nextoncology.com   
Sponsors and Collaborators
NextPoint Therapeutics, Inc.
More Information
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Responsible Party: NextPoint Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06240728    
Other Study ID Numbers: NPX887-001
First Posted: February 5, 2024    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NextPoint Therapeutics, Inc.:
B7-H7
HHLA2
solid tumor malignancies
monoclonal antibody
 Dose escalation
Dose expansion
RECIST
Additional relevant MeSH terms:
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Neoplasms