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NCT05873686 | RECRUITING | Advanced Solid Tumor

A Phase 1 Clinical Study of NXP900 in Subjects with Advanced Cancers
Sponsor:

Nuqectis Pharma, Inc.

Brief Summary:

The purpose of this dose escalation study is to evaluate the safety profile of escalating doses and dose schedules of NXP900.

Condition or disease

Advanced Solid Tumor

Intervention/treatment

NXP900

Phase

PHASE1

Detailed Description:

This is a dose escalation study of NXP900 administered to patients with advanced cancers. The study will propose dose and dose schedules for future studies.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Clinical Study of NXP900 in Subjects with Advanced Cancers
Actual Study Start Date : 2023-10-26
Estimated Primary Completion Date : 2025-04
Estimated Study Completion Date : 2025-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Provide written informed consent.
  • 2. 18 years old or older.
  • 3. Advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator.
  • 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion Criteria
  • 1. Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
  • 2. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.
  • 3. Ongoing toxic manifestations of previous treatments \> Grade 2 with the exception of alopecia and neuropathy.
  • 4. Subjects with treated brain metastases with evidence of progression within 28 days after central nervous system (CNS)-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan) during the Screening period.
  • 5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .
  • 6. Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide).
  • 7. Major surgery from which the subject has not yet recovered.
A Phase 1 Clinical Study of NXP900 in Subjects with Advanced Cancers

Location Details

NCT05873686

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic

Phoenix, Arizona, United States, 85054

RECRUITING

United States, Colorado

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

Mayo Clinic

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United Kingdom,

Western General Hospital - NHS Lothian

Edinburgh, United Kingdom, EH4 2XU

RECRUITING

United Kingdom,

The Royal Marsden NHS Foundation and Trust

London, United Kingdom, Jaya Taj