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New treatment option for Advanced Solid Tumor
Official title A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
ClinicalTrials.gov ID: NCT05873686
What this study is testing
What is NXP900?
NXP900 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part A
- Provide written informed consent.
- 18 years old or older.
- Advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are...
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
You likely can't join if
- people with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
- Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas...
- Ongoing toxic manifestations of previous treatments \> Grade 2 with the exception of alopecia and neuropathy.
- people with treated brain metastases with evidence of progression within 28 days after central nervous system (CNS)-directed treatment, as...
- Female people who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and...
- Male people with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of...
See the full eligibility criteria
- Part A
- Provide written informed consent.
- 18 years old or older.
- 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.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- people with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
- 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. people can continue to receive...
- Ongoing toxic manifestations of previous treatments \> Grade 2 with the exception of alopecia and neuropathy.
- people 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...
- Female people 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 .
- Male people 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).
- Major surgery from which the subject has not yet recovered. Part B: Inclusion Criteria:
- Provide written informed consent.
- 18 years old or older.
- Advanced, metastatic, and/or progressive solid tumors with pathogenic molecular alterations:
- Non-small cell lung cancer (adenocarcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation
- Non-small cell lung cancer (squamous cell carcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation
- Renal cancer; NF2 pathogenic mutation
- Mesothelioma; NF2 pathogenic mutation
- Other solid tumors with a NF2, FAT1 or LATS1 pathogenic gene mutation or TYMS, YAP1, YES1, or TAZ1 gene amplification, or cholangiocarcinoma with IDH1 or IDH2 mutations.
- Must have received 1-3 prior therapies appropriate for their tumor type and stage of disease
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (or mRECIST 1.1 for people with pleural mesothelioma).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Exclusion Criteria:
- people with the following combination of cancer type and pathogenic molecular alterations are excluded:
- people with colorectal cancer, glioma, melanoma, or anaplastic thyroid conditions with BRAF mutations.
- people with NSCLC with BRAF or EGFR mutations or HER2 overexpression.
- people with breast cancer, gastric cancer, esophageal junction adenocarcinoma or biliary cancer with HER2 alterations,
- people with anal, penile, cervical or head and neck cancers with a prior history of human papilloma virus (HPV) infection.
- Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days (42 days for nitrosoureas, mitomycin-C) prior to first dose of NXP900. people can continue to...
- Ongoing toxic manifestations of previous treatments \> Grade 2 with the exception of alopecia and neuropathy.
- Female people 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 .
- Male people 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).
- Major surgery from which the subject has not yet recovered.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Denver, Colorado, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Irving, Texas, United States
- Fairfax, Virginia, United States
- Edinburgh, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; La Jolla, California, United States; Denver, Colorado, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Rochester, Minnesota, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.