NCT05958199SuspendedPhase 1
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
Source: ClinicalTrials.gov · Last updated 27 Jun 2025
Reason given: Business decision
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 131 (estimated)
- First submitted
- 23 Jun 2023
- Start date
- 21 Jul 2023
- Primary completion date
- 20 Sept 2025
- Lead sponsor
- NextPoint Therapeutics, Inc.
- Diseases
- Bladder cancer, Cervical cancer, Colorectal cancer, Endometrial cancer, Kidney cancer, Liver and biliary tract cancer, Lung cancer, Pancreatic cancer, Prostate cancer, Sarcoma, Triple-negative breast cancer
- NCT number
- NCT05958199
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia, chronic neuropathy > 6 months, or changes in skin pigmentation
Other illness
- 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
Other
- Have known or suspected brain metastases, unless they are clinically stable
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center | Baltimore | United States | Unknown status |
| Massachusetts General Hospital | Boston | United States | Unknown status |
| NEXT Oncology-Fairfax | Fairfax | United States | Unknown status |
| MD Anderson Cancer Center | Houston | United States | Unknown status |
| Sarah Cannon Research Institute - Oncology Partners | Nashville | United States | Unknown status |
| Albert Einstein Medical College Montefiore Medical Center | New York | United States | Unknown status |
| NEXT Oncology San Antonio | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.