Metastatic Malignant NeoplasmPhase 1NCT05958199
A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7
A Phase 1 study testing NPX267 in people with Metastatic Malignant Neoplasm, run by NextPoint Therapeutics, Inc. at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm
- What is being tested?
- NPX267
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Jul 2023to 20 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
NEXT Oncology-Fairfax
Fairfax, Virginia, 22031
MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, 37203
Albert Einstein Medical College Montefiore Medical Center
New York, New York, 10461
NEXT Oncology-San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase 1a/1b, Dose-Escalation/Dose-Expansion Study of NPX267 in Subjects With Solid Tumors Known to Express HHLA2/B7-H7
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.
Read the 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.
- Conditions
- Metastatic Malignant Neoplasm
- Being tested
- NPX267
- 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
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Colorectal Neoplasms, Cholangiocarcinoma, Pancreatic Neoplasms, Carcinoma, Transitional Cell, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPX267Drug
NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal
| Study group | Role | What they receive |
|---|---|---|
| NPX267 Treatment | Experimental | Not described Receives: Drug: NPX267 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity
Number of subjects with dose limiting toxicity
Measured: 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
Measured: 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
Measured: up to 12 weeks from first dose
Secondary outcomes (5)
Area under the concentration curve (AUC) of NPX267
Measurement of plasma concentration over time for exposure to NPX267
Measured: 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
Measurement of the clearance of NPX267 from plasma over time
Measured: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Maximum plasma concentration (Cmax) of NPX267
Measured: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)
Overall survival
Average length of survival for treated patients
Measured: From first dose until death from any cause through 30 months
Immunogenicity of NPX267
Number of participants with anti-drug antibodies
Measured: From first dose through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start21 Jul 2023
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation and dose expansion
- Masking
- None (open label)
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NextPoint Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leena Gandhi, MD, PhD, Study director, NextPoint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958199
- Sponsor's protocol ID
- NPX267-001
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, Dose-Escalation/Dose-Expansion Study of NPX267 in Subjects With Solid Tumors Known to Express HHLA2/B7-H7
- ClinicalTrials.gov ID
- NCT05958199
- Acronym / sponsor ID
- NPX267-001
- Conditions
- Metastatic Malignant Neoplasm
- Keywords
- B7-H7/HHLA2, Non-small cell lung carcinoma, renal cell carcinoma, colorectal carcinoma, cholangiocarcinoma, pancreatic cancer, urothelial carcinoma, gastric gastroesophageal carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Business decision
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- NextPoint Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation and dose expansion
| Arm | Type | Receives |
|---|---|---|
| NPX267 Treatment | Experimental | Drug: NPX267 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPX267NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal | Drug | NPX267 Treatment |
Primary outcome
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
5 secondary outcomes
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)
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)
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
Immunogenicity of NPX267
Time frame: From first dose through one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leena Gandhi, MD, PhD study director
NextPoint
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NPX267 in people with Metastatic Malignant Neoplasm, run by NextPoint Therapeutics, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (time frame: from first dose through 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.