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NXP800

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Nuvectis Pharma, Inc.|Last Updated: Aug 8, 2025

Target and mechanism

Molecular targetGCN2
Target classGene
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment45

FDA Designations

ORPHAN_DRUGFAST_TRACK

Clinical trial landscape

NXP800 · 1 trial · 8 indications

Phase 1 1
NCT05226507A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian CancerAdvanced Solid Tumor
ACTIVE NOT_RECRUITING45 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Number of patients with treatment related adverse events, clinical laboratory abnormalities, dose limiting toxicities
Day 28
Part B: Estimates of disease response by RECIST v 1.1
Baseline to 30 days post last dose of NXP800
Part B: Number of patients with treatment related adverse events, and/or clinical laboratory abnormalities.
Baseline to 30 days post last dose of NXP800

Secondary Endpoints

Area under the concentration-time curve (AUC) of NXP800
First dose through Day 29
Maximum observed concentration (Cmax) of NXP800
First dose through Day 29
Time to peak concentration (Tmax) of NXP800
First dose through Day 29
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Dose EscalationEXPERIMENTALEscalating doses of NXP800 administered orally once or twice daily.
Part B: Expansion in Ovarian Cancers Cohort 1EXPERIMENTALSubjects will be treated with NXP800 at 50 mg/day orally.
Part B: Expansion in Ovarian Cancers Cohort 2EXPERIMENTALSubjects will be treated with NXP800 at 75 mg/day orally.

Interventions

NameTypeDescription
NXP800DRUGNXP800 is an anti-neoplastic, oral small molecule.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Part A Inclusion Criteria: * Provide written informed consent. * 18 years old or older. * Life expectancy of at least 12 weeks. * Histologically- or cytologically-confirmed, advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for ...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT05226507primaryCompletionDate: changed
LOWMay 24, 2026NCT05226507studyFirstPostDate: changed

Frequently asked questions about NXP800

What is NXP800 used for?

NXP800 is an investigational small molecule being developed for the treatment of advanced solid tumors, including ovarian cancer subtypes such as ovarian clear cell carcinoma and ovarian endometrioid adenocarcinoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does NXP800 target?

NXP800 targets GCN2, a gene that encodes a kinase involved in cellular stress responses. By inhibiting GCN2, NXP800 is designed to interfere with tumor cell survival mechanisms. This target is being studied in the context of advanced solid tumors, particularly those with ARID1A gene mutations.

Who makes NXP800?

NXP800 is being developed by Nuvectis Pharma, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol NVCT. The company is conducting clinical trials to evaluate the safety and efficacy of NXP800 in patients with advanced cancers.

What phase is NXP800 in?

NXP800 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied in clinical trials. The drug has received Orphan Drug and Fast Track designations from the FDA for certain indications.

What clinical trials is NXP800 in?

NXP800 is being studied in a Phase 1 clinical trial with the identifier NCT05226507. This trial is active but not recruiting and is enrolling approximately 45 patients with advanced solid tumors, including ovarian cancer subtypes. The study is being conducted in the United States and the United Kingdom.

Is NXP800 the same as other drugs?

NXP800 is the sole name provided for this investigational drug. It is not known to have any alternative names or aliases. The drug is being developed by Nuvectis Pharma, Inc. and is currently in Phase 1 trials for advanced solid tumors.