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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Nuvectis Pharma, Inc.
Study ID
NCT05873686
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Mesothelioma
  • NSCLC (Non-small Cell Lung Cancer)
  • Non-Small Cell Squamous Lung Cancer
  • Non-small Cell Lung Adenocarcinoma
  • Renal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NXP900 — DRUG
    NXP900 is an orally administered SRC/YES1 kinase inhibitor

Study Details

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 in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.

Key Dates

First listed
May 24, 2023
Start date
Oct 26, 2023
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation (Part A)
    Escalating doses of NXP900 are planned with a starting dose level of 20 mg once per day.
  • Experimental: Dose Expansion (Part B)
    Participants will receive the selected dose of NXP900

Primary Outcome Measure

Number of patients with treatment related adverse events and/or clinical laboratory abnormalities [ Time Frame: Up to 30 days post treatment ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
855-776-0015
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Sarah Cannon Research Institute at HealthONEDenverColorado80218
720 754-2610
Mayo ClinicJacksonvilleFlorida32224
855-776-0015
University of ChicagoChicagoIllinois60637-
Mayo Clinic RochesterRochesterMinnesota55905-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Cleveland ClinicClevelandOhio44195-
Oregon Health and Science UniversityPortlandOregon97239
503-494-6865
NEXT Oncology HoustonHoustonTexas77054-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Jordi Rodon Ahnert, MD, PhD
713 792-5603
NEXT Oncology DallasIrvingTexas75039-
NEXT Oncology VirginiaFairfaxVirginia22031-

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Mayo Clinic· Phoenix, AZUC San Diego Moores Cancer Center· La Jolla, CASarah Cannon Research Institute at HealthONE· Denver, COMayo Clinic· Jacksonville, FLUniversity of Chicago· Chicago, ILMayo Clinic Rochester· Rochester, MN

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