Advanced or Metastatic Solid Tumor MalignanciesPhase 1/2NCT05023486
NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies
A Phase 1/2 study testing NP-G2-044 Monotherapy, Anti-PD-1 Therapy and NP-G2-044 Combination therapy in people with Advanced or Metastatic Solid Tumor Malignancies, run by Novita Pharmaceuticals, Inc. at 18 sites in United States.
Trial summary
Multicenter, open-label study in patients with advanced or metastatic solid tumor malignancies to evaluate the safety, tolerability, and preliminary anti-tumor efficacy, PK, and pharmacodynamics of continuously dosed NP-G2-044 monotherapy and NP-G2-044 in combination with anti-PD-1 therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumor Malignancies
- What is being tested?
- NP-G2-044 Monotherapy, Anti-PD-1 Therapy and NP-G2-044 Combination therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 18 sitesUnited States
- Study dates
- 7 Dec 2021to 30 Jun 2026
- Phase
- Phase 1/2
- 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
- Male or female ≥18 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy of > 6 months;
- Abilty to swallow capsules and tablets;
- Adequate organ and bone marrow function, defined by the following:
- ANC >1500 cells/μL; Hemoglobin >9.0 g/dL; Platelet count >100,000 cells/μL; Total bilirubin ≤1.5 mg/dL; Albumin ≥3.0 g/dL; Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase ≤2.5 × upper limit of normal (ULN); Creatinine clearance ≥50 mL/min; and Prothrombin time and partial thromboplastin time ≤1.5 × ULN.
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- Female patients of childbearing potential must have a negative serum or urine pregnancy test at Screening and within 24 hours (if urine test) or 72 hours (if serum test) before the first dose of NP-G2-044. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required and must be negative for the patient to be eligible; Note: A woman is considered to be childbearing potential unless she is postmenopausal (≥1 year without menses and confirmed with a follicle-stimulating hormone [FSH] test) or surgically sterilized via bilateral oophorectomy, hysterectomy, bilateral tubal ligation, or successful Essure® placement with a documented confirmation test at least 3 months after the procedure.
- Male patients must be surgically sterile or willing to use a highly effective double-barrier contraception method (e.g., male condom with diaphragm or male condom with cervical cap) upon study entry, while on NP-G2-044, and for a period of at least 4 months following the last dose of NP-G2-044; and
- Able to understand and voluntarily sign a written informed consent form (ICF) and willing and able to comply with protocol requirements.
- Patients must meet all the following criteria to receive NP-G2-044 monotherapy in the study:
- Have a histopathologically confirmed advanced or metastatic solid tumor malignancy for which standard therapies are no longer effective, not tolerated or ineligible for the patient to receive;
- Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- For monotherapy expansion cohort A (after the Mono-RP2D has been identified), patients must have:
- Gynecologic malignancies including ovarian, endometrial/uterine, fallopian tube, cervical, vulvar, and vaginal cancers; or
- Epidermal growth factor receptor (EGFR)-high (2+ or 3+ staining per DAKO criteria or genomic sequencing data showing 3 or more copies of the EGFR gene) triple-negative breast cancer (TNBC).
- For Monotherapy Expansion Cohort B, patient must have advanced or metastatic solid tumors malignancy
- Inclusion Criteria for NP-G2-044 Combination Therapy Patients must meet the following criteria to receive NP-G2-044 in combination with anti-PD-1 therapy in the study:
- Have measurable disease per RECIST 1.1;
- For Combination Therapy Expansion Cohort A:
- Patients must meet 1 of the following criteria to enroll in Combination Therapy Expansion Cohort A:
- Have initiated anti-PD-(L)1 therapy in accordance with the package insert and have been receiving the anti-PD-(L)1 therapy for ≥3 months (with therapy currently ongoing) and have stable disease (defined either by post-treatment onset radiographic scan or ≥3 months without radiographic or clinical evidence of progression), or had an initial period of stable disease and now have an initial scan demonstrating progressive disease per RECIST 1.1. or
- Have discontinued prior anti-PD-(L)1 therapy and are now eligible for de novo NP-G2-044 plus standard of care anti-PD-1 therapy.
- For Combination Therapy Expansion Cohorts B through E:
- Patients must meet 1 of the following criteria to enroll in Combination Therapy Expansion Cohorts B through E:
- Have initiated anti-PD-(L)1 therapy. in accordance with the package insert and have been receiving the anti-PD-(L)1 therapy for >3 months (with therapy currently ongoing) and have stable disease (as defined above), or had an initial period of stable disease or response and now have an initial scan demonstrating progressive disease per RECIST 1.1; or
- Have confirmed progressive disease and discontinued prior anti-PD-(L)1 therapy and are now eligible for de novo NP-G2-044 plus standard of care anti-PD-1 therapy.
- For Combination Therapy Expansion Cohort B, patients must have cutaneous squamous cell carcinoma (CSCC) (human papilloma virus [HPV]-positive or -negative; documentation of HPV status is required);
- For Combination Therapy Expansion Cohort C, patients must have either:
- Esophageal squamous cell carcinoma (ESCC) (HPV-positive or -negative; documentation of HPV status is required); or
- Oropharyngeal squamous cell carcinoma (OPSCC) (HPV-positive or -negative; documentation of HPV status is required).
- For Combination Therapy Expansion Cohort D, patients must have non muscle invasive bladder cancer (NMIBC) meeting Bacillus Calmette-Guérin (BCG)-unresponsive criteria;
- For Combination Therapy Expansion Cohort E, patients must have microsatellite instability high (MSI-H) cancer;
- For Combination Therapy Expansion Cohorts F and G:
- For Combination Therapy Expansion Cohort F, patients must be immunotherapy naïve (I O naïve), have pancreatic ductal adenocarcinoma (PDAC), and meet the following criteria:
- Have had stable disease or response with at least 4 months of standard of care chemotherapy;
- Have no liver metastasis; and
- Have albumin within the normal range at Screening and >3.5 g/dL (±10%) 3 days before Cycle 1 Day 1.
- For Combination Therapy Expansion Cohort G, patients must be I O naïve, have platinum resistant ovarian cancer (PROC), and meet the following criteria:
- Had disease recurrence during or within 6 months after last administration of platinum-based chemotherapy; and
- Received no more than 2 prior regimens of systemic therapy after development of platinum resistance.
Who cannot join
- Received chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of NP-G2-044; Note: Prior immunotherapy is allowed for patients receiving NP-G2-044 monotherapy. For PDAC patients in Combination Therapy Expansion Cohort F: received systemic therapy within 2 weeks of the first dose of NP-G2-044.
- Unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than NCI CTCAE v5.0 Grade ≤2 alopecia or neuropathy) not yet resolved to NCI CTCAE v5.0 Grade ≤1; Note: Patients who experienced a Grade ≥3 anti-PD-1-related AE per NCI CTCAE v5.0 are excluded unless recovered and approved by the Novita Medical Monitor or designee.
- Receiving any other investigational agent(s) or have received an investigational agent within 4 weeks of the first dose of NP-G2-044; Note: Patients who have progressed on NP-G2-044 treatment prior to this study are not eligible
- Known untreated brain metastases or treated brain metastases that have not been radiographically and clinically stable (i.e., not requiring steroids) ≥4 weeks prior to study enrollment;
- QTc by Fridericia method >470 msec or electrocardiogram (ECG) with evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the Investigator;
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, hypertension, unstable angina pectoris, cardiac arrhythmia, autoimmune or inflammatory diseases, or psychiatric illness/social situations that would limit compliance with study requirements;
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- Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during the study or within 90 days after dosing of NP-G2-044;
- Received prior allogenic hematopoietic stem cell transplantation or allogenic bone marrow transplantation;
- Received prior solid organ transplantation;
- Ongoing immunosuppressive therapy (≥10 mg/day of prednisone or its equivalent);
- Requires the use of a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, or CYP2D6 during the study;
- History of clinically meaningful gastrointestinal bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months of study enrollment;
- Excluded by the Sponsor due to medical history, physical examination findings, clinical laboratory results, prior medications, or other entrance criteria; or
- For PDAC patients in Combination Therapy Expansion Cohort F only: have a documented rise in tumor markers within the last 4 months.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of Cincinnati (UC) - Cancer Institute
Cincinnati, Ohio, 45219
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of Texas Southwestern
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope
Duarte, California, 91010
Virginia Cancer Specialists
Fairfax, Virginia, 22031
University of Kansas Cancer Center
Fairway, Kansas, 66205
University of Florida (UF) - Shands Cancer Center
Gainesville, Florida, 32610
Indiana University (IU) Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
City of Hope Irvine Lennar
Irvine, California, 92618
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, 07962
Hoag Memorial Hospital Presbyterian - Gynecologic Oncology Associates
Newport Beach, California, 92663
Nuvance Health
Norwalk, Connecticut, 06856
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298
Honor Health Research Institute
Scottsdale, Arizona, 85258
University of Arizona - Cancer Center
Tucson, Arizona, 85719
About this study
Multicenter, open-label study in patients with advanced or metastatic solid tumor malignancies to evaluate the safety, tolerability, and preliminary anti-tumor efficacy, PK, and pharmacodynamics of continuously dosed NP-G2-044 monotherapy and NP-G2-044 in combination with anti-PD-1 therapy.
- Being tested
- NP-G2-044 Monotherapy, Anti-PD-1 Therapy, NP-G2-044 Combination therapy
- Keywords
- Advanced or Metastatic Solid Tumor Malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP-G2-044 MonotherapyDrug
1600 mg QD, 2000mg QD, and 2100 mg QD
Anti-PD-1 TherapyDrug
previously initiated per standard of care, at a dose and frequency in accordance with the package insert
NP-G2-044 Combination therapyDrug
1600 mg QD or 2100 mg QD
| Study group | Role | What they receive |
|---|---|---|
| NP-G2-044 Monotherapy - Capsule/Tablet | Experimental | NP-G2-044 capsule/tablet PO QD for each 28-day cycle Receives: Drug: NP-G2-044 Monotherapy |
| NP-G2-044 Combination Therapy With Anti-PD-1 Therapy | Experimental | NP-G2-044 capsules PO QD for each 28-day cycle, Anti-PD-1 Therapy per standard of care, at a dose and frequency in accordance with the package insert Receives: Drug: Anti-PD-1 Therapy; Drug: NP-G2-044 Combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the NP-G2-044 Monotherapy Recommended Phase 2 Dose (RP2D)
Measured: 6 months
Number of incidences of Treatment Emergent Adverse Events with NP-G2-044 monotherapy
Will use NCI CTCAE v5.0
Measured: Time of first dose of any study drug(s) until 30 days after the last dose of study drug(s)
NP-G2-044 anti-tumor preliminary efficacy signals when administered as continuously dosed monotherapy assessed by RECIST 1.1
(computed tomography [CT] or magnetic resonance imaging [MRI])
Measured: 24 months
Identification of the RP2D for patients receiving NP-G2-044 in combination with anti-PD-1 therapy
Measured: 9 months
Number of incidences of Treatment Emergent Adverse Events with NP-G2-044 and anti-PD-1 combination therapy
Will use NCI CTCAE v5.0
Measured: Time of first dose of any study drug(s) until 30 days after the last dose of study drug(s)
NP-G2-044 anti-tumor preliminary efficacy signals when administered in combination with anti-PD-1 therapy assessed by RECIST 1.1
(computed tomography [CT] or magnetic resonance imaging [MRI])
Measured: 24 months
Secondary outcomes (7)
Identify and characterize preliminary anti-tumor activity of NP-G2-044 in combination with anti-PD-1 therapy
Anti-tumor activity assessed using iRECIST
Measured: 24 months
Pharmacokinetics (PK) of NP-G2-044 monotherapy: AUC
Area under the plasma concentration versus time curve
Measured: 6 months
Pharmacokinetics (PK) of NP-G2-044 monotherapy: Tmax
Time to peak plasma concentration
Measured: 6 months
Pharmacokinetics (PK) of NP-G2-044 monotherapy: Cmax
Peak plasma concentration
Measured: 6 months
Pharmacokinetics (PK) of NP-G2-044 and anti-PD-1 Combination therapy: AUC
Area under the plasma concentration versus time curve
Measured: 9 months
Pharmacokinetics (PK) of NP-G2-044 and anti-PD-1 Combination therapy: Tmax
Time to peak plasma concentration
Measured: 9 months
Pharmacokinetics (PK) of NP-G2-044 and anti-PD-1 Combination therapy: Cmax
Peak plasma concentration
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start7 Dec 2021
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid Tumor MalignanciesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novita Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jillian Zhang, Ph.D., Study director, Novita Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023486
- Sponsor's protocol ID
- NP-G2-044-P2-01
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT05023486
- Acronym / sponsor ID
- NP-G2-044-P2-01
- Keywords
- Advanced or Metastatic Solid Tumor Malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Novita Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 26 Aug 2021 (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.
Multicenter, open-label study in patients with advanced or metastatic solid tumor malignancies to evaluate the safety, tolerability, and preliminary anti-tumor efficacy, PK, and pharmacodynamics of continuously dosed NP-G2-044 monotherapy and NP-G2-044 in combination with anti-PD-1 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NP-G2-044 Monotherapy - Capsule/Tablet | Experimental | Drug: NP-G2-044 MonotherapyNP-G2-044 capsule/tablet PO QD for each 28-day cycle |
| NP-G2-044 Combination Therapy With Anti-PD-1 Therapy | Experimental | Drug: Anti-PD-1 Therapy, Drug: NP-G2-044 Combination therapyNP-G2-044 capsules PO QD for each 28-day cycle, Anti-PD-1 Therapy per standard of care, at a dose and frequency in accordance with the package insert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Male or female ≥18 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy of > 6 months;
- Abilty to swallow capsules and tablets;
- Adequate organ and bone marrow function, defined by the following:
Key exclusion criteria (14 listed)
- Received chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of NP-G2-044; Note: Prior immunotherapy is allowed for patients receiving NP-G2-044 monotherapy. For PDAC patients in Combination Therapy Expansion Cohort F: received systemic therapy within 2 weeks of the first dose of NP-G2-044.
- Unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than NCI CTCAE v5.0 Grade ≤2 alopecia or neuropathy) not yet resolved to NCI CTCAE v5.0 Grade ≤1; Note: Patients who experienced a Grade ≥3 anti-PD-1-related AE per NCI CTCAE v5.0 are excluded unless recovered and approved by the Novita Medical Monitor or designee.
- Receiving any other investigational agent(s) or have received an investigational agent within 4 weeks of the first dose of NP-G2-044; Note: Patients who have progressed on NP-G2-044 treatment prior to this study are not eligible
- Known untreated brain metastases or treated brain metastases that have not been radiographically and clinically stable (i.e., not requiring steroids) ≥4 weeks prior to study enrollment;
- QTc by Fridericia method >470 msec or electrocardiogram (ECG) with evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the Investigator;
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 |
|---|---|---|
| NP-G2-044 Monotherapy1600 mg QD, 2000mg QD, and 2100 mg QD | Drug | NP-G2-044 Monotherapy - Capsule/Tablet |
| Anti-PD-1 Therapypreviously initiated per standard of care, at a dose and frequency in accordance with the package insert | Drug | NP-G2-044 Combination Therapy With Anti-PD-1 Therapy |
| NP-G2-044 Combination therapy1600 mg QD or 2100 mg QD | Drug | NP-G2-044 Combination Therapy With Anti-PD-1 Therapy |
Primary outcome
Identification of the NP-G2-044 Monotherapy Recommended Phase 2 Dose (RP2D)
Time frame: 6 months
Number of incidences of Treatment Emergent Adverse Events with NP-G2-044 monotherapy
Time frame: Time of first dose of any study drug(s) until 30 days after the last dose of study drug(s)
Will use NCI CTCAE v5.0
NP-G2-044 anti-tumor preliminary efficacy signals when administered as continuously dosed monotherapy assessed by RECIST 1.1
Time frame: 24 months
(computed tomography [CT] or magnetic resonance imaging [MRI])
Identification of the RP2D for patients receiving NP-G2-044 in combination with anti-PD-1 therapy
Time frame: 9 months
Number of incidences of Treatment Emergent Adverse Events with NP-G2-044 and anti-PD-1 combination therapy
Time frame: Time of first dose of any study drug(s) until 30 days after the last dose of study drug(s)
Will use NCI CTCAE v5.0
NP-G2-044 anti-tumor preliminary efficacy signals when administered in combination with anti-PD-1 therapy assessed by RECIST 1.1
Time frame: 24 months
(computed tomography [CT] or magnetic resonance imaging [MRI])
7 secondary outcomes
Identify and characterize preliminary anti-tumor activity of NP-G2-044 in combination with anti-PD-1 therapy
Time frame: 24 months
Pharmacokinetics (PK) of NP-G2-044 monotherapy: AUC
Time frame: 6 months
Pharmacokinetics (PK) of NP-G2-044 monotherapy: Tmax
Time frame: 6 months
Pharmacokinetics (PK) of NP-G2-044 monotherapy: Cmax
Time frame: 6 months
Pharmacokinetics (PK) of NP-G2-044 and anti-PD-1 Combination therapy: AUC
Time frame: 9 months
Pharmacokinetics (PK) of NP-G2-044 and anti-PD-1 Combination therapy: Tmax
Time frame: 9 months
Pharmacokinetics (PK) of NP-G2-044 and anti-PD-1 Combination therapy: Cmax
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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.
Jillian Zhang, Ph.D. study director
Novita Pharmaceuticals, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NP-G2-044 Monotherapy, Anti-PD-1 Therapy and NP-G2-044 Combination therapy in people with Advanced or Metastatic Solid Tumor Malignancies, run by Novita Pharmaceuticals, Inc. at 18 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 40 inclusion and 14 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: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identification of the NP-G2-044 Monotherapy Recommended Phase 2 Dose (RP2D) (time frame: 6 months). 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 9 Oct 2026.