NXP900 for Advanced Cancers

Recruiting at 5 trial locations

Overseen By Erin Belshaw

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nuvectis Pharma, Inc.

Must be taking: Bisphosphonates, GnRH agonists

Must not be taking: Chemotherapy, Radiotherapy

Disqualifiers: HER2+ malignancies, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, NXP900 (also known as eCF506), for individuals with advanced solid tumors. It examines the safety and effectiveness of NXP900, particularly when other treatments are unsuitable or unavailable. The trial consists of two parts: the first determines the optimal dose, and the second applies this dose to specific genetic alterations in cancers such as lung, renal, and mesothelioma. Individuals with advanced cancers unresponsive to other treatments might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot have had radiotherapy, chemotherapy, or certain other treatments within 28 days before starting the trial. You can continue taking bisphosphonates for bone disease or GnRH agonists for prostate cancer.

Is there any evidence suggesting that NXP900 is likely to be safe for humans?

Research has shown that NXP900 has been safe in earlier studies. In one study with 33 patients who had advanced cancers, researchers tested NXP900 for safety. The results indicated that the treatment was generally well-tolerated at doses up to 250 mg per day, with most patients not experiencing serious side effects at these levels.

This trial is in its first phase, focusing on assessing the treatment's safety in humans for the first time. While earlier studies suggest it is safe, this trial will help confirm those findings and ensure safety at different doses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancers, which often include chemotherapy and targeted therapies, NXP900 represents a novel approach by specifically targeting a new mechanism in cancer cells. Researchers are excited about NXP900 because it aims to inhibit a particular protein that plays a crucial role in cancer cell survival and proliferation. This targeted action not only holds the potential for greater effectiveness but also may lead to fewer side effects compared to conventional treatments.

What evidence suggests that NXP900 might be an effective treatment for advanced cancers?

Research shows that NXP900, the investigational treatment in this trial, could help treat some advanced cancers. Studies have found it particularly effective in lab models of esophageal and head and neck cancers. These cancers responded well to NXP900, suggesting it might work well in people too. NXP900 targets specific proteins, YES1 and SRC, which aid cancer cell growth. Early results also suggest that NXP900 might be useful when other treatments, like ALK inhibitors, stop working. This evidence gives hope that NXP900 could become an important new option for cancer patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Gerald Falchook, MD

Principal Investigator

Sarah Cannon Cancer Institute, HealthOne Denver

Udai Banerji, Prof

Principal Investigator

Institute of Cancer Research, Royal Marsden NHS Foundation Trust

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have no effective therapy options or where such treatments are not suitable. Participants must be able to measure their disease, have a good performance status (ECOG 0-1), and agree to use contraception if they can become pregnant. Those with certain types of cancer, recent other treatments, untreated brain metastases, or unresolved major surgery side effects cannot join.

Inclusion Criteria

Provide written informed consent

My cancer is advanced or spreading and there are no suitable treatments for me.

I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

I am still recovering from a major surgery.

I haven't had cancer treatment, except for bone disease or prostate cancer therapy, in the last 28 days.

I am a man and will use a condom and spermicide if my partner can have children.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of NXP900 starting at 20 mg once per day

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NXP900

Trial Overview The study is testing different doses and schedules of a new drug called NXP900 on patients with various advanced cancers. It's an early-stage trial (Phase 1) focused on finding out the safest dose levels and how often the drug should be given.

How Is the Trial Designed?

Group I: Dose Expansion (Part B) Experimental Treatment 1 Intervention

Participants will receive the selected dose of NXP900

Group II: Dose Escalation (Part A) Experimental Treatment 1 Intervention

Escalating doses of NXP900 are planned with a starting dose level of 20 mg once per day.

NXP900 is already approved in United States for the following indications:

Approved in United States as NXP900 for:

• None approved; currently in Phase 1 clinical trials

Who Is Running the Clinical Trial?

Nuvectis Pharma, Inc.

Lead Sponsor

Trials

2

Recruited

100+

Published Research Related to This Trial

The study found that ECT2 is a key factor in the growth of triple-negative breast cancer (TNBC) cells, influencing their proliferation, invasion, and apoptosis, as demonstrated through in vitro assays with the HCC1806 cell line.

Silencing ECT2 significantly enhanced the effectiveness of paclitaxel (PTX) treatment in TNBC, suggesting that targeting ECT2 could be a promising strategy to improve breast cancer therapies and potentially lead to the development of new targeted treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Ect2 Expression on the Growth of Triple-Negative Breast Cancer Cells with Paclitaxel Intervention. Wang, H., Liu, H., Li, J., et al.[2022]

Extracellular heat-shock protein 90 (eHsp90) plays a significant role in promoting cancer stem-like characteristics in prostate cancer cells, enhancing their self-renewal and growth, which could contribute to tumor progression.

eHsp90 is associated with increased expression of stem-like markers and the epithelial to mesenchymal transition (EMT) factor Snail, suggesting it may help create a unique population of cancer stem cells that are more resistant to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secreted heat shock protein 90 promotes prostate cancer stem cell heterogeneity. Nolan, KD., Kaur, J., Isaacs, JS.[2023]

GPNMB is a marker indicating poor prognosis in triple-negative breast cancer (TNBC), and its levels can increase in response to various cancer therapies, which may affect the efficacy of the drug Glembatumumab Vedotin.

Inhibiting heat shock protein 90 (HSP90) enhances both the expression and surface localization of GPNMB, making breast cancer cells more sensitive to Glembatumumab Vedotin, suggesting that combining HSP90 inhibitors with this drug could improve treatment outcomes for metastatic TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HSP90 inhibitors induce GPNMB cell-surface expression by modulating lysosomal positioning and sensitize breast cancer cells to glembatumumab vedotin. Biondini, M., Kiepas, A., El-Houjeiri, L., et al.[2022]

In a phase III trial involving 677 patients with advanced lung adenocarcinoma, the combination of ganetespib and docetaxel did not improve overall survival compared to docetaxel alone, with median survival times of 10.9 months versus 10.5 months, respectively.

The addition of ganetespib also did not enhance progression-free survival or any secondary outcomes, and the most common serious side effect was neutropenia, occurring in 30.9% of patients receiving the combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Phase III Study of Ganetespib, a Heat Shock Protein 90 Inhibitor, With Docetaxel Versus Docetaxel in Advanced Non-Small-Cell Lung Cancer (GALAXY-2). Pillai, RN., Fennell, DA., Kovcin, V., et al.[2020]

The HSP90 inhibitor NVP-AUY922 effectively inhibited the growth of oral squamous cell carcinoma cells in laboratory studies and induced apoptosis, suggesting it can be a powerful treatment option.

In animal models, NVP-AUY922 demonstrated significant antitumor effects by degrading key oncoproteins and reducing factors like p-Akt and VEGF, which are involved in tumor progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor effect of novel HSP90 inhibitor NVP-AUY922 against oral squamous cell carcinoma. Okui, T., Shimo, T., Hassan, NM., et al.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05873686

A Phase 1 Clinical Study of NXP900 in Subjects With ... 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 ...

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/5520/757848/Abstract-5520-NXP900-a-phase-1-first-in-class-YES1

Abstract 5520: NXP900, a phase 1, first-in-class YES1/SRC ... Altogether, these data suggest that NXP900 may have therapeutic potential in cancers with acquired resistance to ALK inhibitors. A FIH ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11388391/

The SRC family kinase inhibitor NXP900 demonstrates ... Here, we demonstrate that esophageal squamous cell carcinomas and head and neck squamous cell carcinomas are exquisitely sensitive to NXP900 treatment in cell ...

4. quiverquant.com quiverquant.com/news/Nuvectis+Pharma%2C+Inc.+Provides+Update+on+NXP900+Clinical+Program+and+Q3+2025+Financial+Results

Nuvectis Pharma, Inc. Provides Update on NXP900 ... Nuvectis Pharma reports progress on NXP900 clinical trials, financial results, and increased cash reserves. Phase 1b program initiated.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e15133

Preclinical efficacy of NXP900, a YES1/SRC kinase ... NXP900 has marked antitumor efficacy in esophageal carcinoma models in vitro and in vivo providing substantial proof of concept for ...

6. firstwordpharma.com firstwordpharma.com/story/5985354

Nuvectis Pharma Provides Final Clinical Data Update from ... The Phase 1a dose escalation study evaluated the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of NXP900 in patients with advanced ...

7. nasdaq.com nasdaq.com/articles/nuvectis-pharma-inc-announces-positive-phase-1a-data-nxp900-demonstrating-robust

Nuvectis Pharma, Inc. Announces Positive Phase 1a Data ... The Phase 1a study showed robust pharmacodynamic responses and an acceptable safety profile for NXP900 at doses up to 250 mg/day.

8. biospace.com biospace.com/press-releases/nuvectis-pharma-provides-poster-presentation-highlights-for-nxp900-from-the-2025-aacr-nci-eortc-international-conference-on-molecular-targets-and-cancer-therapeutics

Nuvectis Pharma Provides Poster Presentation Highlights ... ” NXP900 Clinical Safety, PKPD and CYP450 Interactions (Link to Poster). In 33 patients with advanced cancers, the safety of NXP900 ...