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

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.

Conditions

Metastatic Malignant Neoplasm

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Metastatic Malignant Neoplasm
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States, 21287

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

New York

Albert Einstein Medical College Montefiore Medical Center, New York, New York, United States, 10461

Nashville

Sarah Cannon Research Institute Oncology Partners, Nashville, Tennessee, United States, 37203

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

San Antonio

NEXT Oncology-San Antonio, San Antonio, Texas, United States, 78229

Fairfax

NEXT Oncology-Fairfax, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NextPoint Therapeutics, Inc.,

Study Record Dates

2026-01