Trial Title:
A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7
NCT ID:
NCT05958199
Condition:
Metastatic Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Dose escalation and dose expansion
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NPX267
Description:
NPX267 will be administered by intravenous infusion every three weeks until documented
disease progression or participant withdrawal
Arm group label:
NPX267 Treatment
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.
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Wendler
Phone:
410-502-5140
Email:
dschul15@jhmi.edu
Investigator:
Last name:
Yasser Ged, MD
Email:
Principal Investigator
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Gainor, MD
Phone:
617-724-4000
Email:
JGAINOR@MGH.HARVARD.EDU
Investigator:
Last name:
Justin Gainor, MD
Email:
Principal Investigator
Facility:
Name:
Albert Einstein Medical College Montefiore Medical Center
Address:
City:
New York
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gunnar Lauer
Email:
glauer@montefiore.org
Investigator:
Last name:
Haiying Cheng, MD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Phone:
844-482-4812
Email:
asksarah@sarahcannon.com
Investigator:
Last name:
Melissa Johnson, MD
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aung Naing, MD
Phone:
713-563-3885
Email:
anaing@mdanderson.org
Investigator:
Last name:
Aung Naing, MD
Email:
Principal Investigator
Facility:
Name:
NEXT Oncology-San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cheryl Merendon
Phone:
210-580-9521
Email:
cmerendon@nextoncology.com
Investigator:
Last name:
Ildefonso I Rodriguez Rivera, MD
Email:
Principal Investigator
Facility:
Name:
NEXT Oncology-Fairfax
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Blake Patterson
Phone:
703-783-4505
Email:
bpatterson@nextoncology.com
Investigator:
Last name:
Alexander Spira, MD
Email:
Principal Investigator
Start date:
July 21, 2023
Completion date:
January 2026
Lead sponsor:
Agency:
NextPoint Therapeutics, Inc.
Agency class:
Industry
Source:
NextPoint Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05958199
