A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7
Status
RECRUITING
Phase
PHASE1
Age
≥ 18 Years
Enrollments
131Conditions
Metastatic Malignant NeoplasmDrugs
NPX267Summary
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.
Detailed 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.
Locations
7 locations Found with status Recruiting
Eligibility Criteria
Inclusion 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
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 the equivalent of more than 10 mg prednisone daily
* History of grade 3 immune-related pneumonitis or colitis
Study Plan
NPX267 Treatment
DRUG:
NPX267Description:
NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal
Outcome Measures
Primary Outcome Measures
Incidence of dose limiting toxicity
Incidence of treatment-emergent adverse events
Number of subjects with tumor response in tumors expressing B7-H7/HHLA2
Secondary Outcome Measures
Area under the concentration curve (AUC) of NPX267
Half-life in circulation (T1/2) of NPX267
Maximum plasma concentration (Cmax) of NPX267
Overall survival
Immunogenicity of NPX267
Timeline
Last Updated
August 28, 2024Start Date
July 24, 2023Today
February 5, 2025Completion Date ( Estimated )
January 1, 2026
Sponsors of this trial
Lead Sponsor
NextPoint Therapeutics, Inc.
RECRUITING 
21 - 64 Years