New pill shows promise against tough cancers in early trial
NCT ID NCT05873686
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study tests a new oral drug called NXP900 in people with advanced solid tumors (like lung, kidney, or mesothelioma) that have not responded to standard treatments. The trial has two parts: first, finding the right dose, and then seeing if the drug shrinks tumors. It is a first-in-human study, so safety and effectiveness are still unknown.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NXP900 (an oral drug that blocks certain cancer-driving proteins)
- What this could lead to
- If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 140 participants, so the drug may not prove effective or safe in larger studies. Side effects are unknown at this stage.
Why investors are watching
Nuvectis Pharma is running a first-in-human phase 1 trial of its drug NXP900 in 140 patients with advanced solid tumors, including those with specific genetic changes the drug targets. For a micro-cap company with few assets, this early safety and dosing data is the main event that will show whether the drug works as designed and is safe enough to keep developing.
If it works: If NXP900 shows acceptable safety and signs of tumor control in patients with the targeted genetic alterations, Nuvectis could advance the drug to later-stage trials and strengthen its position as a developer of precision cancer therapies.
If it fails: Phase 1 trials often fail because the drug proves too toxic or does not shrink tumors as hoped. A poor result or a slow enrollment could set the company back significantly, since it has few other products to fall back on.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2023
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Part A 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. Part B: Inclusion Criteria: 1. Provide written informed consent. 2. 18 years old or older. 3. Advanced, metastatic, and/or progressive solid tumors with pathogenic molecular alterations: 1. Non-small cell lung cancer (adenocarcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation 2. Non-small cell lung cancer (squamous cell carcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation 3. Renal cancer; NF2 pathogenic mutation 4. Mesothelioma; NF2 pathogenic mutation 5. 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. 4. Must have received 1-3 prior therapies appropriate for their tumor type and stage of disease 5. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (or mRECIST 1.1 for subjects with pleural mesothelioma). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Exclusion Criteria: 1. Subjects with the following combination of cancer type and pathogenic molecular alterations are excluded: 1. Subjects with colorectal cancer, glioma, melanoma, or anaplastic thyroid conditions with BRAF mutations. 2. Subjects with NSCLC with BRAF or EGFR mutations or HER2 overexpression. 3. Subjects with breast cancer, gastric cancer, esophageal junction adenocarcinoma or biliary cancer with HER2 alterations, 2. Subjects with anal, penile, cervical or head and neck cancers with a prior history of human papilloma virus (HPV) infection. 3. 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. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer. 4. Ongoing toxic manifestations of previous treatments \> Grade 2 with the exception of alopecia and neuropathy. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
13 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
-
Mayo Clinic
RECRUITINGPhoenix, Arizona, 85054, United States
-
Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
-
Mayo Clinic Rochester
RECRUITINGRochester, Minnesota, 55905, United States
-
Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10021, United States
-
NEXT Oncology Dallas
RECRUITINGIrving, Texas, 75039, United States
-
NEXT Oncology Houston
RECRUITINGHouston, Texas, 77054, United States
-
NEXT Oncology Virginia
RECRUITINGFairfax, Virginia, 22031, United States
-
Oregon Health and Science University
RECRUITINGPortland, Oregon, 97239, United States
-
Sarah Cannon Research Institute at HealthONE
RECRUITINGDenver, Colorado, 80218, United States
-
The Royal Marsden NHS Foundation and Trust
COMPLETEDLondon, SW3 6JJ, United Kingdom
-
The University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
-
UC San Diego Moores Cancer Center
RECRUITINGLa Jolla, California, 92093, United States
-
University of Chicago
RECRUITINGChicago, Illinois, 60637, United States
-
Western General Hospital - NHS Lothian
COMPLETEDEdinburgh, EH4 2XU, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Oral drug VT3989 takes on chemo in mesothelioma survival test
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?