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Evaluating NXP900 for advanced cancers

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

Phase 1 Interventional Nuvectis Pharma, Inc. · NCT05873686

This study is testing a new drug called NXP900 to see if it's safe and how much of it can be given to people with advanced cancers that have no good treatment options.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years and up
SexAll
SponsorNuvectis Pharma, Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations12 sites (Phoenix, Arizona and 11 other locations)
Trial IDNCT05873686 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 dose escalation study aimed at assessing the safety and tolerability of NXP900 in patients with advanced solid tumors. Participants will receive escalating doses of the drug to determine the optimal dosing schedule for future studies. The study focuses on individuals with metastatic or progressive cancers for which no effective therapies are available. The results will help inform subsequent clinical trials and treatment options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced, metastatic solid tumors that have no authorized or effective treatment options available.

Not a fit: Patients with HER2+ overexpressing malignancies or those currently undergoing certain treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers who currently have limited or no effective therapies.

How similar studies have performed: Other studies involving dose escalation of novel therapies in advanced cancers have shown promise, indicating that this approach is both relevant and potentially beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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, TAZ1 gene amplification
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.
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, EGFR or HER2 alterations.
   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.

Where this trial is running

Phoenix, Arizona and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorNSCLCRenal CancerMesotheliomaNon-Small Cell Squamous Lung CancerNon-small Cell Lung AdenocarcinomaSolid TumorCarcinoma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.