Metastatic Malignant NeoplasmPhase 1NCT07563829
NPX372, a B7-H7:CD3 Bispecific Antibody, in Selected Solid Tumor Malignancies
A Phase 1 study testing NPX372 in people with Metastatic Malignant Neoplasm, run by NextPoint Therapeutics, Inc. at 6 sites in United States.
Trial summary
NPX372 is an antibody drug (protein drug) that blocks a specific protein which is found to be increased on the surface of cancer cells called B7-H7 and, at the same time, binds to immune cells (T cells) through a receptor called CD3. The effect of this binding is to activate T cells to kill cancer cells with B7-H7. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm
- What is being tested?
- NPX372
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 May 2026to 1 Jul 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document.
- Histologically or cytologically confirmed recurrent or metastatic solid tumor refractory to standard of care therapy in one of the following indications: NSCLC, RCC, CRC, PDAC, biliary tract tumors, gastric and gastro-esophageal carcinoma, and ovarian carcinoma.
- Measurable disease by RECIST v1.1 criteria.
- Age ≥19 years.
- Adequate organ function as defined by:
- Calculated creatinine clearance (CrCl) must be ≥45 mL/min (by Cockroft-Gault formula).
Show all 16Show fewer
- Total bilirubin ≤1.5× the upper limit of normal (ULN) unless prior history of Gilbert's syndrome who must have total bilirubin <3.0 mg/dL.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN, or ≤5× ULN if due to liver involvement by tumor.
- Serum albumin ≥3.0 g/dL.
- Hemoglobin ≥9.0 g/dL, limited transfusion to reach this value may be allowed after discussion with the Sponsor's Medical Monitor.
- Platelets ≥100 × 109 cells/L.
- Absolute neutrophil count ≥1.5 ×109 cells/L.
- Baseline oxygen saturation > 90% on room air
- All participants will be required to have sufficient archival tissue available. For backfill cohort participants, archival tissue will be used to confirm B7-H7 expression for enrollment (see inclusion criterion 2) during pre-screening.
- -If 3 participants are already enrolled in any backfill cohort, subsequent participants will be required to have a fresh biopsy during the screening period. These participants should therefore only be selected if judged safe to undergo a fresh biopsy.
- Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 60 days after the last dose of study drug is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
Who cannot join
- Prior treatment toxicity not resolved to grade 1 or below including any:
- Systemic anti-cancer treatment: exceptions include alopecia, chronic stable neuropathy for >4 months, change in skin pigmentation, grade 2 anemia, or requiring replacement therapy for endocrine abnormalities (in this setting, symptoms should have resolved to grade 1 or below). Systemic anti-cancer treatment within 10 days prior to start of study is not allowed.
- Limited-field radiotherapy: radiation therapy within 7 days prior to start of study or extended-field thoracic radiotherapy within 8 weeks of the first dose of study drug is not allowed.
- Major surgery: major surgery (excluding placement of catheters, vascular access, or biopsy) within 4 weeks of the first dose of study drug is not allowed.
- Clinically or radiographically unstable brain metastases: Participants with known brain metastases should be clinically stable and asymptomatic. Participants with a history of brain metastases should have an MRI during screening. For participants who are noted to have new or enlarging brain metastases during screening, treatment with stereotactic radiosurgery (SRS) is permitted with the standard limited field radiotherapy washout of >7 days. Participants requiring more extensive radiation (ie, fractionated stereotactic radiation or whole-brain radiation) would need a washout period of ≥4 weeks. Participants should be off corticosteroids for central nervous system (CNS) treatment for at least 7 days prior to dosing.
- Cardiac conditions as follows: history of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification; cardiac arrhythmias >Grade 2, unstable angina, coronary/peripheral artery bypass graft within 3 months, or evidence of 2nd- or 3rd-degree heart block.
Show all 15Show fewer
- Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV] infections except as below, and active clinical tuberculosis), or renal transplant; ongoing or active infection, or social situations that would limit compliance with study requirements.
- HIV: Seropositive participants without an acquired immunodeficiency syndrome (AIDS) defining illness and those with AIDS defining conditions on anti-retroviral therapy (ART) are eligible if they are healthy and have a CD4 count >350 cells/mm3 at the time of screening (Day ≤28 days). Participants on ART must have HIV RNA levels <50 copies/mL or the lower limit of quantification (LLOQ) using a local assay at the time of screening. Participants on ART must have been on a stable regimen without dose modification for at least 4 weeks prior screening.
- HBV: Participants with HBsAg positivity are eligible if they have undetectable viral load and have received HBV anti-viral therapy for at least 4 weeks prior to screening.
- HCV: Participants with a history of HCV infection are eligible if they have undetectable HCV viralload at screening and have completed curative therapy >4 weeks prior to screening.
- Any evidence of hemoptysis or gastrointestinal (GI) bleeding within the last 3 months prior to screening.
- Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily.
- History of unresolved prior immune-related toxicity except for endocrine abnormalities requiring replacement therapy or vitiligo.
- Prior treatment with a cytokine therapy or cytokine fusion therapy.
- History of prior or concomitant malignancy that requires other active treatment except for prostate cancer without radiographic evidence of disease on long-term androgen deprivation therapy for >6 months (ie, leuprolide).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Johns Hopkins
Baltimore, Maryland, 21287
Yasser Ged, MD, Ph.D.
- Recruiting
NEXT
Fairfax, Virginia, 22031
Brianne Kaiser, 210-580-9511, bkaiser@nextoncology.com
Alexander Spira, MD, Ph.D.
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Aung Naing, MD, 713 563-3885
- Recruiting
University of California - San Diego
La Jolla, California, 92093
Sandip Patel, MD, Ph.D.
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Alicia Edge, 615-329-7274, alicia.edge@scri.com
Melissa Johnson, MD, Ph.D.
- Recruiting
Montefiore
The Bronx, New York, 10461
Haiyang Cheng, MD, Ph.D.
About this study
Official title: A Phase 1 Dose-Escalation Study of NPX372, a Bispecific Antibody Targeting B7-H7 and CD3, in Selected Solid Tumor Malignancies
NPX372 is an antibody drug (protein drug) that blocks a specific protein which is found to be increased on the surface of cancer cells called B7-H7 and, at the same time, binds to immune cells (T cells) through a receptor called CD3. The effect of this binding is to activate T cells to kill cancer cells with B7-H7.
In this research study we are:
- Evaluating the safety and possible effectiveness of NPX372.
- Identifying a safe and tolerable dose or doses for further study.
Participants who are treated will receive an intravenous (IV) infusion of NPX372 if their disease has not progressed, and be closely monitored by the treating physicians.
Read the detailed description
NPX372 is being developed as a therapeutic in solid tumor malignancies including non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), pancreatic adenocarcinoma (PDAC), biliary tract tumors, ovarian carcinoma, and gastric/gastro-esophageal carcinoma. This study is a Phase 1 study with primary dose-escalation occurring in the aforementioned solid tumor malignancies (main cohorts). Backfill cohorts from a selected subset of these tumor types will be utilized to enrich for dose optimization in participants whose tumors have high B7-H7 expression determined by prospective screening of archival tissue.
- Conditions
- Metastatic Malignant Neoplasm
- Being tested
- NPX372
- Keywords
- solid tumor, B7-H7, bispecific antibody, dose escalation, CD3, HHLA2, T-cell engaging
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPX372Drug
NPX372 is administered by IV infusion. The first cycle will be 3 weeks long and NPX372 will be given on the first day and one week later during this 3-week period. For most dose levels, the first day's dose (C1D1) will be a lower dose, which will serve as a "priming dose". The full dose will start on the second dose. After the first two doses, NPX372 will be administered every other week for up to 6 months. After that time, NPX372 will be given about once a month. Treatment may continue for up to 2 years as long as the patient is deriving benefit.
| Study group | Role | What they receive |
|---|---|---|
| NPX372 | Experimental | NPX372 is provided in single-use 5 mg vials at 1 mg per mL and is administered as an IV infusion over 60 minutes. Receives: Drug: NPX372 |
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
Measured: From first dose through 21 days
Overall incidence of Dose Limiting Equivalent Toxicity (DLET) during treatment
Number of participants with DLET
Measured: From first dose up to 24 months
Incidence of AEs, characterized overall and by type, seriousness, relationship to NPX372, and severity.
Number and type of AEs categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: From first dose up to 24 months
Number of participants with abnormal laboratory parameters, vital signs, electrocardiogram (ECG) parameters, physical examination findings as characterized by type, frequency, timing, relationship to NPX372, and severity
Measured: From first dose up to 24 months
Drug discontinuation, drug interruptions/delays and dose reductions due to treatment-related AEs
Number of participants with changes to their dosing schedule as a result of treatment-related AEs
Measured: From first dose up to 24 months
Number of participants with AEs, DLTs (inclusive of DLETs), and PD changes within blood
Measured: From first dose up to 24 months
Secondary outcomes (10)
Objective Response Rate (ORR)
ORR: the proportion of participants with best overall response, i.e., complete response (CR) or partial response (PR), per RECIST 1.1
Measured: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first
Duration of Response (DOR)
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.
Measured: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first
Disease Control Rate (DCR)
DCR: the proportion of participants with a best ORR + Stable Disease (SD)
Measured: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first]
Progression-Free Survival (PFS)
PFS: the duration from the start of treatment until tumor progression or death of any cause
Measured: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first
NPX372 serum PK (Cmax)
Cmax - measurement of highest NPX372 plasma concentration over time
Measured: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
NPX372 serum PK (AUC0-last)
AUC-last: measurement of total NPX372 plasma concentration over time
Measured: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
NPX372 serum PK time of Cmax (Tmax)
Tmax - time to NPX372 maxiumum plasma concentration
Measured: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
NPX372 serum PK terminal half-life (T1/2)
T1/2 - measurement of the clearance of NPX372 from plasma over time
Measured: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
Degree of accumulation, incidence, and magnitude of ADA
Number of participants with anti-drug antibodies (ADA)
Measured: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
Overall Survival (OS)
Average length of survival for treated participants
Measured: From first dose until death from any cause through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 May 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 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
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NextPoint Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leena Gandhi, MD, Ph.D., Study director, NextPoint Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563829
- Sponsor's protocol ID
- NPX372-001
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2026
- Last updated
- 8 Sep 2026
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study of NPX372, a Bispecific Antibody Targeting B7-H7 and CD3, in Selected Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT07563829
- Acronym / sponsor ID
- NPX372-001
- Conditions
- Metastatic Malignant Neoplasm
- Keywords
- solid tumor, B7-H7, bispecific antibody, dose escalation, CD3, HHLA2, T-cell engaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- NextPoint Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 May 2026 (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.
NPX372 is an antibody drug (protein drug) that blocks a specific protein which is found to be increased on the surface of cancer cells called B7-H7 and, at the same time, binds to immune cells (T cells) through a receptor called CD3. The effect of this binding is to activate T cells to kill cancer cells with B7-H7.
In this research study we are:
- Evaluating the safety and possible effectiveness of NPX372.
- Identifying a safe and tolerable dose or doses for further study.
Participants who are treated will receive an intravenous (IV) infusion of NPX372 if their disease has not progressed, and be closely monitored by the treating physicians.
Detailed description
NPX372 is being developed as a therapeutic in solid tumor malignancies including non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), pancreatic adenocarcinoma (PDAC), biliary tract tumors, ovarian carcinoma, and gastric/gastro-esophageal carcinoma. This study is a Phase 1 study with primary dose-escalation occurring in the aforementioned solid tumor malignancies (main cohorts). Backfill cohorts from a selected subset of these tumor types will be utilized to enrich for dose optimization in participants whose tumors have high B7-H7 expression determined by prospective screening of archival tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- dose escalation
| Arm | Type | Receives |
|---|---|---|
| NPX372 | Experimental | Drug: NPX372NPX372 is provided in single-use 5 mg vials at 1 mg per mL and is administered as an IV infusion over 60 minutes. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Histologically or cytologically confirmed recurrent or metastatic solid tumor refractory to standard of care therapy in one of the following indications: NSCLC, RCC, CRC, PDAC, biliary tract tumors, gastric and gastro-esophageal carcinoma, and ovarian carcinoma.
- Measurable disease by RECIST v1.1 criteria.
- Age ≥19 years.
- Adequate organ function as defined by:
Key exclusion criteria (15 listed)
- Prior treatment toxicity not resolved to grade 1 or below including any:
- Clinically or radiographically unstable brain metastases: Participants with known brain metastases should be clinically stable and asymptomatic. Participants with a history of brain metastases should have an MRI during screening. For participants who are noted to have new or enlarging brain metastases during screening, treatment with stereotactic radiosurgery (SRS) is permitted with the standard limited field radiotherapy washout of >7 days. Participants requiring more extensive radiation (ie, fractionated stereotactic radiation or whole-brain radiation) would need a washout period of ≥4 weeks. Participants should be off corticosteroids for central nervous system (CNS) treatment for at least 7 days prior to dosing.
- Cardiac conditions as follows: history of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification; cardiac arrhythmias >Grade 2, unstable angina, coronary/peripheral artery bypass graft within 3 months, or evidence of 2nd- or 3rd-degree heart block.
- Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV] infections except as below, and active clinical tuberculosis), or renal transplant; ongoing or active infection, or social situations that would limit compliance with study requirements.
- Any evidence of hemoptysis or gastrointestinal (GI) bleeding within the last 3 months prior to screening.
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 |
|---|---|---|
| NPX372NPX372 is administered by IV infusion. The first cycle will be 3 weeks long and NPX372 will be given on the first day and one week later during this 3-week period. For most dose levels, the first day's dose (C1D1) will be a lower dose, which will serve as a "priming dose". The full dose will start on the second dose. After the first two doses, NPX372 will be administered every other week for up to 6 months. After that time, NPX372 will be given about once a month. Treatment may continue for up to 2 years as long as the patient is deriving benefit. | Drug | NPX372 |
Primary outcome
Incidence of Dose Limiting Toxicity (DLT)
Time frame: From first dose through 21 days
Number of participants with DLT
Overall incidence of Dose Limiting Equivalent Toxicity (DLET) during treatment
Time frame: From first dose up to 24 months
Number of participants with DLET
Incidence of AEs, characterized overall and by type, seriousness, relationship to NPX372, and severity.
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
Number of participants with abnormal laboratory parameters, vital signs, electrocardiogram (ECG) parameters, physical examination findings as characterized by type, frequency, timing, relationship to NPX372, and severity
Time frame: From first dose up to 24 months
Drug discontinuation, drug interruptions/delays and dose reductions due to treatment-related AEs
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
Number of participants with AEs, DLTs (inclusive of DLETs), and PD changes within blood
Time frame: From first dose up to 24 months
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first
Duration of Response (DOR)
Time frame: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first
Disease Control Rate (DCR)
Time frame: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first]
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
NPX372 serum PK (Cmax)
Time frame: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
NPX372 serum PK (AUC0-last)
Time frame: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
NPX372 serum PK time of Cmax (Tmax)
Time frame: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
NPX372 serum PK terminal half-life (T1/2)
Time frame: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
Degree of accumulation, incidence, and magnitude of ADA
Time frame: Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment and 90-day follow-up after Cycle 7 (28 days)
Overall Survival (OS)
Time frame: From first dose until death from any cause through 24 months
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 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Malignant Neoplasm
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
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, Ph.D. study director
NextPoint Therapeutics, Inc.
6 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 NPX372 in people with Metastatic Malignant Neoplasm, run by NextPoint Therapeutics, Inc. at 6 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 16 inclusion and 15 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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 ((508) 214-1115, 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 6 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 8 Sep 2026.