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A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7
A Phase 1a/1b, Dose-Escalation/Dose-Expansion Study of NPX267 in Subjects With Solid Tumors Known to Express HHLA2/B7-H7
1 other identifier
interventional
131
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2023
CompletedStudy Start
First participant enrolled
July 21, 2023
CompletedFirst Posted
Study publicly available on registry
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2025
CompletedJune 27, 2025
June 1, 2025
2.2 years
June 23, 2023
June 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of dose limiting toxicity
Number of subjects with dose limiting toxicity
from first dose through 21 days
Incidence of treatment-emergent adverse events
Number and type of adverse events categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
up to 12 weeks from first dose
Number of subjects with tumor response in tumors expressing B7-H7/HHLA2
The proportion of subjects with complete or partial responses or stable disease as defined by RECIST 1.1 criteria
up to 12 weeks from first dose
Secondary Outcomes (5)
Area under the concentration curve (AUC) of NPX267
Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Half-life in circulation (T1/2) of NPX267
Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Maximum plasma concentration (Cmax) of NPX267
Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Overall survival
From first dose until death from any cause through 30 months
Immunogenicity of NPX267
From first dose through one year
Other Outcomes (1)
Change in biomarkers of activity
From first dose through one year
Study Arms (1)
NPX267 Treatment
EXPERIMENTALInterventions
NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Leena Gandhi, MD, PhD
NextPoint
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2023
First Posted
July 24, 2023
Study Start
July 21, 2023
Primary Completion
September 20, 2025
Study Completion
September 20, 2025
Last Updated
June 27, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share