SUSPENDED

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

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

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.

Official Title

A Phase 1a/1b, Dose-Escalation/Dose-Expansion Study of NPX267 in Subjects With Solid Tumors Known to Express HHLA2/B7-H7

Quick Facts

Study Start:2023-07-21
Study Completion:2025-09-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT05958199

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 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
  2. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  3. * Normal bone marrow, kidney and liver function
  4. * Willing to use highly effective contraceptive measures throughout the trial
  1. * Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia, chronic neuropathy \> 6 months, or changes in skin pigmentation
  2. * Have known or suspected brain metastases, unless they are clinically stable
  3. * Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily
  4. * History of grade 3 immune-related pneumonitis or colitis

Contacts and Locations

Principal Investigator

Leena Gandhi, MD, PhD
STUDY_DIRECTOR
NextPoint

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NextPoint Therapeutics, Inc.

  • Leena Gandhi, MD, PhD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-07-21
Study Completion Date2025-09-20

Study Record Updates

Study Start Date2023-07-21
Study Completion Date2025-09-20

Terms related to this study

Keywords Provided by Researchers

  • B7-H7/HHLA2
  • Non-small cell lung carcinoma
  • renal cell carcinoma
  • colorectal carcinoma
  • cholangiocarcinoma
  • pancreatic cancer
  • urothelial carcinoma
  • gastric gastroesophageal carcinoma
  • triple negative breast carcinoma
  • endometrial carcinoma
  • cervical cancer
  • osteosarcoma
  • prostate cancer
  • RECIST
  • Dose escalation
  • Dose expansion

Additional Relevant MeSH Terms

  • Metastatic Malignant Neoplasm