A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7
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| ClinicalTrials.gov Identifier: NCT05958199 |
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Recruitment Status :
Recruiting
First Posted : July 24, 2023
Last Update Posted : May 3, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Malignant Neoplasm | Drug: NPX267 | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 131 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Dose escalation and dose expansion |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1a/1b, Dose-Escalation/Dose-Expansion Study of NPX267 in Subjects With Solid Tumors Known to Express HHLA2/B7-H7 |
| Actual Study Start Date : | July 21, 2023 |
| Estimated Primary Completion Date : | January 2026 |
| Estimated Study Completion Date : | January 2026 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: NPX267 Treatment |
Drug: NPX267
NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal |
- Incidence of dose limiting toxicity [ Time Frame: from first dose through 21 days ]Number of subjects with dose limiting toxicity
- Incidence of treatment-emergent adverse events [ Time Frame: up to 12 weeks from first dose ]Number and type of adverse events categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- Number of subjects with tumor response in tumors expressing B7-H7/HHLA2 [ Time Frame: up to 12 weeks from first dose ]The proportion of subjects with complete or partial responses or stable disease as defined by RECIST 1.1 criteria
- Area under the concentration curve (AUC) of NPX267 [ Time Frame: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles) ]Measurement of plasma concentration over time for exposure to NPX267
- Half-life in circulation (T1/2) of NPX267 [ Time Frame: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles) ]Measurement of the clearance of NPX267 from plasma over time
- Maximum plasma concentration (Cmax) of NPX267 [ Time Frame: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles) ]
- Overall survival [ Time Frame: From first dose until death from any cause through 30 months ]Average length of survival for treated patients
- Immunogenicity of NPX267 [ Time Frame: From first dose through one year ]Number of participants with anti-drug antibodies
- Change in biomarkers of activity [ Time Frame: From first dose through one year ]Exploratory analysis of biomarkers from collected tumor and blood samples
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05958199
| Contact: Leena Gandhi, MD, PhD | 857 209-0486 | NPX267-001@nextpointtx.com |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Danielle Wendler 410-502-5140 dschul15@jhmi.edu | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Justin Gainor, MD 617-724-4000 JGAINOR@MGH.HARVARD.EDU | |
| United States, New York | |
| Albert Einstein Medical College | Recruiting |
| New York, New York, United States, 10461 | |
| Contact: Gunnar Lauer glauer@montefiore.org | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact 844-482-4812 asksarah@sarahcannon.com | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Aung Naing, MD 713-563-3885 anaing@mdanderson.org | |
| NEXT Oncology-San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Cheryl Merendon 210-580-9521 cmerendon@nextoncology.com | |
| United States, Virginia | |
| NEXT Oncology-Fairfax | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Contact: Blake Patterson 703-783-4505 bpatterson@nextoncology.com | |
| Responsible Party: | NextPoint Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT05958199 |
| Other Study ID Numbers: |
NPX267-001 |
| First Posted: | July 24, 2023 Key Record Dates |
| Last Update Posted: | May 3, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Neoplasms |