RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1a/1b Dose Escalation and Dose Expansion Study of NPX887 in Participants With Solid Tumor Malignancies Known to Express B7-H7/HHLA2

Quick Facts

Study Start:2024-01-22
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06240728

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to, or intolerant of, standard of care therapy in one of the following indications:
  2. * Phase 1a (Dose Escalation): Non-small cell lung carcinoma (NSCLC), small cell lung carcinoma (SCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), gastric and gastro-esophageal carcinoma, esophageal adenocarcinoma, biliary tract cancers, ovarian carcinoma, and other solid tumor types known to express B7-H7/HHLA2.
  3. * Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized Dose Comparison): participants who have clear cell RCC, EGFR mutant lung adenocarcinoma, or gastric/GEJ adenocarcinoma.
  4. * In Phase 1b, participants must have confirmed B7-H7/HHLA2 expression in their tumor determined via archival tissue IHC testing through a central lab (pre-screening).
  5. * Phase 1a: Evaluable disease (measurable or non-measurable) by RECIST v.1.1 criteria; Phase 1b: Measurable disease by RECIST v1.1 criteria with additional disease-specific enrollment criteria applied to clear cell RCC, EGFR mutant lung adenocarcinoma, or gastric/GEJ adenocarcinoma.
  6. * Fresh tissue biopsies: Participants in Cohorts 2 and above in Phase 1a, the first 10 participants in each cohort of Part 1b, and the first 5 participants at each dose level in Part 1c cohort(s) will be required to have sufficient and adequate tumor tissue samples for a fresh screening biopsy and a mandatory on-treatment biopsy as clinically feasible.
  7. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  8. * Ability to understand and the willingness to sign a written informed consent document
  9. * Willing to use highly effective contraceptive measures throughout the trial.
  1. * Treatment with any of the following:
  2. * Systemic anticancer treatment ≤14 days or within 5 half-lives prior to the first dose of study drug, whichever is shorter.
  3. * Limited-field radiotherapy ≤7 days or extended-field thoracic radiotherapy ≤8 weeks of the first dose of study drug.
  4. * Have any unresolved toxicity of ≥Grade 2 from previous anti-cancer treatment, except for alopecia, chronic stable neuropathy for \>4 months, changes in skin pigmentation, or requiring replacement therapy for endocrine abnormalities.
  5. * Participants with known brain metastases are excluded unless they are clinically stable, with no new or enlarging brain metastases as evidenced on MRI during screening.
  6. * History of Grade 3 immune-related pneumonitis or colitis.
  7. * 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.
  8. * Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily.

Contacts and Locations

Study Contact

Leena Gandhi, MD, PhD
CONTACT
617-999-2144
NPX887-001@nextpointtx.com
Michael O'Meara
CONTACT
617-512-0258
NPX887-001@nextpointtx.com

Study Locations (Sites)

Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215
United States
Albert Einstein Medical College Montefiore Medical Center
Bronx, New York, 10461
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Next Oncology
San Antonio, Texas, 78229
United States
NEXT Oncology-Fairfax
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: NextPoint Therapeutics, Inc.

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

Study Start Date2024-01-22
Study Completion Date2027-08

Study Record Updates

Study Start Date2024-01-22
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • B7-H7
  • HHLA2
  • solid tumor malignancies
  • monoclonal antibody
  • Dose escalation
  • Dose expansion
  • RECIST

Additional Relevant MeSH Terms

  • Metastatic Malignant Neoplasm