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    DRUG:

    NXP800

    i
    Other names: NXP800, NXP 800, NXP-800, CCT361814, CCT 361814, CCT-361814
    Company:
    Cancer Therapeutics CRC, Nuvectis Pharma
    Drug class:
    GCN2 activator
    Related drugs:
    29d
    NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma (clinicaltrials.gov)
    P1, N=7, Terminated, Mayo Clinic | Active, not recruiting --> Terminated | Trial primary completion date: May 2026 --> Aug 2025 | N=30 --> 7 | Trial completion date: May 2026 --> Sep 2025; study sponsor phasing out drug supply
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    NXP800
    2ms
    Advances in Prostate Cancer Treatment: Exploring Molecular Targets and New Strategies in Castration-Resistant Disease. (PubMed, Cureus)
    Key developments include next-generation AR pathway inhibitors, such as darolutamide, with improved safety profiles; PARP inhibitors for patients with DNA repair gene mutations; and PSMA-targeted radioligand therapy. The therapeutic landscape is also expanding to include novel targets such as the heat shock response, with HSF1 inhibitors like NXP800 in clinical trials for treatment-refractory disease. By targeting this molecular heterogeneity, ongoing research aims to deliver more effective, personalized treatments to improve survival and quality of life for men with advanced prostate cancer.
    Review • Journal • PARP Biomarker
    |
    AR (Androgen receptor) • HSF1 (Heat Shock Transcription Factor 1)
    |
    Nubeqa (darolutamide) • NXP800
    3ms
    NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Mayo Clinic | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    NXP800
    5ms
    NXP800-101: A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, Nuvectis Pharma, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ARID1A (AT-rich interaction domain 1A) • BRCA (Breast cancer early onset)
    |
    ARID1A mutation • BRCA mutation
    |
    NXP800
    1year
    NXP800 activates the unfolded protein response, altering AR and E2F function to impact castration-resistant prostate cancer growth. (PubMed, Clin Cancer Res)
    Overall, NXP800 has anti-tumor activity against treatment-resistant PCa models, including molecular subtypes with limited treatment options, supporting its consideration for PCa-specific clinical development.
    Journal
    |
    HSF1 (Heat Shock Transcription Factor 1)
    |
    NXP800
    1year
    NXP800-101: A Phase 1 Clinical Study of NXP800 in Subjects with Advanced Cancers and Expansion in Subjects with Ovarian Cancer (clinicaltrials.gov)
    P1, N=61, Recruiting, Nuvectis Pharma, Inc. | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> May 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    ARID1A (AT-rich interaction domain 1A) • BRCA (Breast cancer early onset)
    |
    ARID1A mutation • BRCA mutation
    |
    NXP800
    over1year
    NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma (clinicaltrials.gov)
    P1, N=30, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    NXP800
    over1year
    NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Mayo Clinic
    New P1 trial • Metastases
    |
    NXP800
    over2years
    HSF1 Pathway Inhibitor Clinical Candidate (CCT361814/NXP800) Developed from a Phenotypic Screen as a Potential Treatment for Refractory Ovarian Cancer and Other Malignancies. (PubMed, J Med Chem)
    Further multiparameter optimization led to the design of the clinical candidate, CCT361814/NXP800 22, a potent and orally bioavailable fluorobisamide, which caused tumor regression in a human ovarian adenocarcinoma xenograft model with on-pathway biomarker modulation and a clean in vitro safety profile. Following its favorable dose prediction to human, 22 has now progressed to phase 1 clinical trial as a potential future treatment for refractory ovarian cancer and other malignancies.
    Journal
    |
    HSF1 (Heat Shock Transcription Factor 1)
    |
    NXP800
    almost3years
    A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer (clinicaltrials.gov)
    P1, N=61, Recruiting, Nuvectis Pharma, Inc. | N=17 --> 61 | Trial completion date: Apr 2023 --> Jun 2025 | Trial primary completion date: Jan 2023 --> Dec 2024
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    ARID1A (AT-rich interaction domain 1A) • BRCA (Breast cancer early onset)
    |
    ARID1A mutation • BRCA mutation
    |
    NXP800
    almost3years
    Activation of the integrated stress response by the developmental HSF1 pathway inhibitor NXP800 (AACR 2023)
    Using an siRNA approach to determine if activation of the ISR components was contributing to growth inhibition following NXP800 exposure, we found that blocking the induction of ATF4 reduced the response of NXP800-sensitive SK-OV-3 human ovarian carcinoma cells to NXP800 treatment.In summary, NXP800 acts on cancer cells to induce activation of the ISR pathway via GCN2, which then leads to inhibition of HSF1 activation. Further studies are underway to determine the precise molecular target of NXP800 and the mechanism of HSF1 pathway inhibition.
    Late-breaking abstract
    |
    ATF4 (Activating Transcription Factor 4) • CHAC1 (ChaC Glutathione Specific Gamma-Glutamylcyclotransferase 1) • HSF1 (Heat Shock Transcription Factor 1)
    |
    NXP800