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    DRUG CLASS:

    GCN2 activator

    Related drugs:
    24d
    A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK) (clinicaltrials.gov)
    P1, N=35, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial • First-in-human
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • HC-7366
    30d
    Activating GCN2 and subsequently the Unfolded Protein Response with the small oral molecule NXP800 delays tumor growth in osteosarcoma. (PubMed, Cell Death Discov)
    Finally, NXP800 delays tumor growth in preclinical OS model by promoting apoptosis. This study is a preclinical proof-of-principle of therapeutic efficacy of NXP800 both in vitro and in vivo, highlighting the relevance of targeting GCN2, and consequently activating the ISR and UPR, to induce apoptosis and inhibit tumor progression in OS.
    Journal
    |
    ATF4 (Activating Transcription Factor 4)
    |
    NXP800
    2ms
    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
    4ms
    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
    4ms
    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
    6ms
    Study of DCC-2812 in Participants With Advanced Genitourinary Cancers (clinicaltrials.gov)
    P1, N=60, Recruiting, Deciphera Pharmaceuticals, LLC | Not yet recruiting --> Recruiting
    Enrollment open
    7ms
    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
    10ms
    Study of DCC-2812 in Participants With Advanced Genitourinary Cancers (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, Deciphera Pharmaceuticals, LLC
    New P1 trial
    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
    over1year
    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
    almost2years
    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
    almost2years
    Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=18, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Aug 2024 --> May 2024
    Enrollment open • Trial initiation date
    |
    Venclexta (venetoclax) • azacitidine • HC-7366