Metastatic Malignant NeoplasmPhase 1NCT06240728
A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2
A Phase 1 study testing NPX887 in people with Metastatic Malignant Neoplasm, run by NextPoint Therapeutics, Inc. at 8 sites in 2 countries.
Trial summary
NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting B7-H7 (HHLA2) that may potentiate an anti-tumor immune response. The goal of this first-in-human study is to learn whether NPX887 is safe and tolerable and shows a preliminary efficacy in participants with B7-H7 (HHLA2) expressing… 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?
- NPX887
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 22 Jan 2024to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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, or intolerant of, standard of care therapy in one of the following indications:
- Phase 1a (Dose Escalation): Non-small cell lung carcinoma (NSCLC), small cell lung carcinoma (SCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), gastric and gastro-esophageal carcinoma, esophageal adenocarcinoma, biliary tract cancers, ovarian carcinoma, and other solid tumor types known to express B7-H7/HHLA2.
- Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized Dose Comparison): participants who have clear cell RCC, EGFR mutant lung adenocarcinoma, or gastric/GEJ adenocarcinoma.
- In Phase 1b, participants must have confirmed B7-H7/HHLA2 expression in their tumor determined via archival tissue IHC testing through a central lab (pre-screening).
- Phase 1a: Evaluable disease (measurable or non-measurable) by RECIST v.1.1 criteria; Phase 1b: Measurable disease by RECIST v1.1 criteria with additional disease-specific enrollment criteria applied to clear cell RCC, EGFR mutant lung adenocarcinoma, or gastric/GEJ adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Ability to understand and the willingness to sign a written informed consent document
- Willing to use highly effective contraceptive measures throughout the trial.
Who cannot join
- Treatment with any of the following:
- Systemic anticancer treatment ≤14 days or within 5 half-lives prior to the first dose of study drug, whichever is shorter.
- Limited-field radiotherapy ≤7 days or extended-field thoracic radiotherapy ≤8 weeks of the first dose of study drug.
- Have any unresolved toxicity of ≥Grade 2 from previous anti-cancer treatment, except for alopecia, chronic stable neuropathy for >4 months, changes in skin pigmentation, or requiring replacement therapy for endocrine abnormalities.
- Participants with known brain metastases are excluded unless they are clinically stable, with no new or enlarging brain metastases as evidenced on MRI during screening.
- History of Grade 3 immune-related pneumonitis or colitis.
- Participants who discontinued prior immunotherapy due to immune-related toxicities, or history of unresolved prior immune-related toxicity except for endocrine abnormalities requiring replacement therapy or vitiligo.
- Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States6 sites
- Active, not recruiting
Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
- Active, not recruiting
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215
- Active, not recruiting
NEXT Oncology-Fairfax
Fairfax, Virginia, 22031
- Active, not recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Active, not recruiting
Next Oncology
San Antonio, Texas, 78229
- Active, not recruiting
Albert Einstein Medical College Montefiore Medical Center
The Bronx, New York, 10461
South Korea2 sites, 2 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Chaeyeon Lee, chaeyo@yuhs.ac
Byoung Chul Cho, MD
- Recruiting
Samsung Medical Center
Seoul, 06351
Jungkyo Kim, jungkyo224.kim@samsung.com
Myung-Ju Ahn, MD
About this study
Official title: A Phase 1a/1b Dose Escalation and Dose Expansion Study of NPX887 in Participants With Solid Tumor Malignancies Known to Express B7-H7/HHLA2
NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting B7-H7 (HHLA2) that may potentiate an anti-tumor immune response. The goal of this first-in-human study is to learn whether NPX887 is safe and tolerable and shows a preliminary efficacy in participants with B7-H7 (HHLA2) expressing tumors at selected dose(s). The main questions it aims to answer are:
- what is an appropriate dose to be given to participants?
- are the side effects of treatment manageable?
- what is the preliminary anti-tumor activities?
Participants who are treated will receive an intravenous (IV) infusion of NPX887 if their disease has not progressed, and be closely monitored by the treating physicians.
Read the detailed description
This study is comprised of Phase 1a (Dose Escalation) and Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized Dose Comparison). Phase 1a will test different doses of NPX887 to determine the optimal dose(s) to continue with in Phase 1b. In the Phase 1b, more participants will be tested to evaluate preliminary activities in multiple disease-specific cohorts and compare the efficacy of the higher and lower doses chosen in Phase 1a.
Throughout the study, safety and preliminary efficacy data will be collected to characterize the clinical activity of NPX887. Samples of blood will be taken to help in an understanding of how NPX887 behaves in the body by assessing the amount of drug in the blood over time, and changes in blood components. Tumor tissue samples will be collected at screening and on-treatment stages for biomarker analysis and pharmacodynamics (PD) evaluation.
- Conditions
- Metastatic Malignant Neoplasm
- Being tested
- NPX887
- Keywords
- B7-H7, HHLA2, solid tumor malignancies, monoclonal antibody, Dose escalation, Dose expansion, RECIST
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPX887Drug
NPX887 will be administered by IV infusion every 3 weeks until documented disease progression or participant withdrawal for up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| NPX887 Treatment | Experimental | Participants will receive NPX887 by IV infusion every 3 weeks. Receives: Drug: NPX887 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT)
Number of participants with DLT in Ph1a
Measured: From first dose through 21 days
Incidence of treatment-emergent adverse events (AEs)
Number and type of AEs categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in Ph1a
Measured: From first dose up to 24 months
Incidence of discontinuations, dosing interruptions, and dose reductions
Number of participants with changes to their dosing schedule as a result of treatment-related AEs in Ph1a
Measured: From first dose up to 24 months
Objective response rate (ORR)
The proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 in Ph1b
Measured: Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
Duration of response (DOR)
The time interval from first occurrence of a documented objective response to the time of disease progression as determined by the Investigator using RECIST 1.1 or death from any cause, whichever comes first, in Ph1b
Measured: Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
Disease control rate (DCR)
The proportion of participants with a best ORR + Stable Disease (SD) in Ph1b
Measured: Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
Progression-free Survival (PFS)
The duration from the start of treatment until tumor progression or death of any cause in Ph1b
Measured: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
Secondary outcomes (7)
Area under the concentration curve (AUC0-24) of NPX887
Measurement of plasma concentration over time for exposure to NPX887
Measured: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 7, then on day 1 every 3 cycles, up to end of treatment and 90-day follow-up
Maximum plasma concentration (Cmax) of NPX887
Measurement of plasma concentration over time for exposure to NPX887
Measured: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 7, then on day 1 every 3 cycles, up to end of treatment and 90-day follow-up
Half-life in blood circulation (T1/2) of NPX887
Measurement of the clearance of NPX887 from plasma over time
Measured: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 7, then on day 1 every 3 cycles, up to end of treatment and 90-day follow-up
Immunogenicity of NPX887
Number of participants with anti-drug antibodies (ADA)
Measured: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 4, then on day 1 every 3 cycles, up to 90-day follow-up
Overall survival (OS)
Average length of survival for treated participants
Measured: From first dose until death from any cause through 24 months
Incidence of AEs, DLTs, PD changes within the tumor and in blood
Number of participants with AEs and type, DLTs, and PD changes in Ph1a
Measured: From first dose through 21 days, or up to 24 months
ORR, DOR, DCR, and PFS
ORR, DOR, DCR, and PFS occur in Ph1a
Measured: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start22 Jan 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
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
- 144 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
- NCT06240728
- Sponsor's protocol ID
- NPX887-001
- Status last verified
- Jun 2025
- First submitted
- 26 Jan 2024
- 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 and Dose Expansion Study of NPX887 in Participants With Solid Tumor Malignancies Known to Express B7-H7/HHLA2
- ClinicalTrials.gov ID
- NCT06240728
- Acronym / sponsor ID
- NPX887-001
- Conditions
- Metastatic Malignant Neoplasm
- Keywords
- B7-H7, HHLA2, solid tumor malignancies, monoclonal antibody, Dose escalation, Dose expansion, RECIST
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- NextPoint Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Feb 2024 (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.
NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting B7-H7 (HHLA2) that may potentiate an anti-tumor immune response. The goal of this first-in-human study is to learn whether NPX887 is safe and tolerable and shows a preliminary efficacy in participants with B7-H7 (HHLA2) expressing tumors at selected dose(s). The main questions it aims to answer are:
- what is an appropriate dose to be given to participants?
- are the side effects of treatment manageable?
- what is the preliminary anti-tumor activities?
Participants who are treated will receive an intravenous (IV) infusion of NPX887 if their disease has not progressed, and be closely monitored by the treating physicians.
Detailed description
This study is comprised of Phase 1a (Dose Escalation) and Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized Dose Comparison). Phase 1a will test different doses of NPX887 to determine the optimal dose(s) to continue with in Phase 1b. In the Phase 1b, more participants will be tested to evaluate preliminary activities in multiple disease-specific cohorts and compare the efficacy of the higher and lower doses chosen in Phase 1a.
Throughout the study, safety and preliminary efficacy data will be collected to characterize the clinical activity of NPX887. Samples of blood will be taken to help in an understanding of how NPX887 behaves in the body by assessing the amount of drug in the blood over time, and changes in blood components. Tumor tissue samples will be collected at screening and on-treatment stages for biomarker analysis and pharmacodynamics (PD) evaluation.
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 |
|---|---|---|
| NPX887 Treatment | Experimental | Drug: NPX887Participants will receive NPX887 by IV infusion every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to, or intolerant of, standard of care therapy in one of the following indications:
- Phase 1a: Evaluable disease (measurable or non-measurable) by RECIST v.1.1 criteria; Phase 1b: Measurable disease by RECIST v1.1 criteria with additional disease-specific enrollment criteria applied to clear cell RCC, EGFR mutant lung adenocarcinoma, or gastric/GEJ adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Ability to understand and the willingness to sign a written informed consent document
- Willing to use highly effective contraceptive measures throughout the trial.
Key exclusion criteria (8 listed)
- Treatment with any of the following:
- Have any unresolved toxicity of ≥Grade 2 from previous anti-cancer treatment, except for alopecia, chronic stable neuropathy for >4 months, changes in skin pigmentation, or requiring replacement therapy for endocrine abnormalities.
- Participants with known brain metastases are excluded unless they are clinically stable, with no new or enlarging brain metastases as evidenced on MRI during screening.
- History of Grade 3 immune-related pneumonitis or colitis.
- Participants who discontinued prior immunotherapy due to immune-related toxicities, or history of unresolved prior immune-related toxicity except for endocrine abnormalities requiring replacement therapy or vitiligo.
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 |
|---|---|---|
| NPX887NPX887 will be administered by IV infusion every 3 weeks until documented disease progression or participant withdrawal for up to 2 years | Drug | NPX887 Treatment |
Primary outcome
Incidence of dose limiting toxicity (DLT)
Time frame: From first dose through 21 days
Number of participants with DLT in Ph1a
Incidence of treatment-emergent adverse events (AEs)
Time frame: From first dose up to 24 months
Number and type of AEs categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in Ph1a
Incidence of discontinuations, dosing interruptions, and dose reductions
Time frame: From first dose up to 24 months
Number of participants with changes to their dosing schedule as a result of treatment-related AEs in Ph1a
Objective response rate (ORR)
Time frame: Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
The proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 in Ph1b
Duration of response (DOR)
Time frame: Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
The time interval from first occurrence of a documented objective response to the time of disease progression as determined by the Investigator using RECIST 1.1 or death from any cause, whichever comes first, in Ph1b
Disease control rate (DCR)
Time frame: Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
The proportion of participants with a best ORR + Stable Disease (SD) in Ph1b
Progression-free Survival (PFS)
Time frame: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
The duration from the start of treatment until tumor progression or death of any cause in Ph1b
7 secondary outcomes
Area under the concentration curve (AUC0-24) of NPX887
Time frame: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 7, then on day 1 every 3 cycles, up to end of treatment and 90-day follow-up
Maximum plasma concentration (Cmax) of NPX887
Time frame: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 7, then on day 1 every 3 cycles, up to end of treatment and 90-day follow-up
Half-life in blood circulation (T1/2) of NPX887
Time frame: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 7, then on day 1 every 3 cycles, up to end of treatment and 90-day follow-up
Immunogenicity of NPX887
Time frame: Following dosing on day 1 of each 21-day treatment cycles up to Cycle 4, then on day 1 every 3 cycles, up to 90-day follow-up
Overall survival (OS)
Time frame: From first dose until death from any cause through 24 months
Incidence of AEs, DLTs, PD changes within the tumor and in blood
Time frame: From first dose through 21 days, or up to 24 months
ORR, DOR, DCR, and PFS
Time frame: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Leena Gandhi, MD, PhD study director
NextPoint
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NPX887 in people with Metastatic Malignant Neoplasm, run by NextPoint Therapeutics, Inc. at 8 sites in 2 countries.
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 8 inclusion and 8 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: looking for participants now, 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 8 sites in United States, South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trials nextpointtx ((888) 929-NEXT, trials@nextpointtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT) (time frame: From first dose through 21 days). The study lists 7 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.