RECRUITING

A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

Conditions

Advanced Solid Tumor NSCLC (Non-small Cell Lung Cancer)Renal Cancer Mesothelioma Non-Small Cell Squamous Lung Cancer Non-small Cell Lung Adenocarcinoma Solid Tumor Carcinoma Neoplasms Adenocarcinoma YES1 YAP1 TAZ1 NF2 FAT1 LATS1 TYMS gene amplification gene mutation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.

Official Title

A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

Quick Facts

Study Start:2023-10-26

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05873686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Erin Belshaw

CONTACT

(201) 627-8129

ebelshaw@nuvectis.com

Shay Shemesh

CONTACT

(201) 614-3153

sshemesh@nuvectis.com

Principal Investigator

Udai Banerji, Prof

PRINCIPAL_INVESTIGATOR

Institute of Cancer Research, Royal Marsden NHS Foundation Trust

Gerald Falchook, MD

PRINCIPAL_INVESTIGATOR

Sarah Cannon Cancer Institute, HealthOne Denver

Study Locations (Sites)

Mayo Clinic

Phoenix, Arizona, 85054

United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Nuvectis Pharma, Inc.

Udai Banerji, Prof, PRINCIPAL_INVESTIGATOR, Institute of Cancer Research, Royal Marsden NHS Foundation Trust
Gerald Falchook, MD, PRINCIPAL_INVESTIGATOR, Sarah Cannon Cancer Institute, HealthOne Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-26

Study Completion Date2027-07

Study Record Updates

Study Start Date2023-10-26

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

Solid Tumor
Carcinoma
Neoplasms
Adenocarcinoma
YES1
YAP1
TAZ1
NF2
FAT1
LATS1
TYMS
gene amplification
gene mutation

Additional Relevant MeSH Terms

Advanced Solid Tumor
NSCLC (Non-small Cell Lung Cancer)
Renal Cancer
Mesothelioma
Non-Small Cell Squamous Lung Cancer
Non-small Cell Lung Adenocarcinoma