NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies

NCT05023486 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: NP-G2-044-P2-01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Advanced or Metastatic Solid Tumor Malignancies

Keywords

Advanced or Metastatic Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (6)

• Identification of the NP-G2-044 Monotherapy Recommended Phase 2 Dose (RP2D)

  6 months

• Number of incidences of Treatment Emergent Adverse Events with NP-G2-044 monotherapy

  Will use NCI CTCAE v5.0

  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 \[MRI\])

  24 months

• Identification of the RP2D for patients receiving NP-G2-044 in combination with anti-PD-1 therapy

  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

  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 \[MRI\])

  24 months

Secondary Outcomes (7)

• Identify and characterize preliminary anti-tumor activity of NP-G2-044 in combination with anti-PD-1 therapy

  24 months

• Pharmacokinetics (PK) of NP-G2-044 monotherapy: AUC

  6 months

• Pharmacokinetics (PK) of NP-G2-044 monotherapy: Tmax

  6 months

• Pharmacokinetics (PK) of NP-G2-044 monotherapy: Cmax

  6 months

• Pharmacokinetics (PK) of NP-G2-044 and anti-PD-1 Combination therapy: AUC

  9 months

Study Arms (2)

NP-G2-044 Monotherapy - Capsule/Tablet

EXPERIMENTAL

NP-G2-044 capsule/tablet PO QD for each 28-day cycle

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

Drug: Anti-PD-1 Therapy; Drug: NP-G2-044 Combination therapy

Interventions

NP-G2-044 Monotherapy DRUG

1600 mg QD, 2000mg QD, and 2100 mg QD

NP-G2-044 Monotherapy - Capsule/Tablet

Anti-PD-1 Therapy DRUG

previously initiated per standard of care, at a dose and frequency in accordance with the package insert

NP-G2-044 Combination Therapy With Anti-PD-1 Therapy

NP-G2-044 Combination therapy DRUG

1600 mg QD or 2100 mg QD

NP-G2-044 Combination Therapy With Anti-PD-1 Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Novita Pharmaceuticals, Inc.: lead

Study Sites (18)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

University of Arizona - Cancer Center

Tucson, Arizona, 85719, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

City of Hope Irvine Lennar

Irvine, California, 92618, United States

Location

Hoag Memorial Hospital Presbyterian - Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

Nuvance Health

Norwalk, Connecticut, 06856, United States

Location

University of Florida (UF) - Shands Cancer Center

Gainesville, Florida, 32610, United States

Location

Indiana University (IU) Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Cancer Center

Fairway, Kansas, 66205, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Atlantic Health System - Morristown Medical Center

Morristown, New Jersey, 07962, United States

Location

University of Cincinnati (UC) - Cancer Institute

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Study Officials

• Jillian Zhang, Ph.D.

  Novita Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 26, 2021
• Study Start: December 7, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)