Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05873686

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

Led by Nuvectis Pharma, Inc. · Updated on 2026-03-03

140

Participants Needed

12

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent.
  • Be 18 years old or older.
  • Have advanced, metastatic, or progressive solid tumors with no authorized or effective therapy available, or such therapy is inappropriate (Part A).
  • Have measurable disease according to RECIST Version 1.1.
  • Have an ECOG performance status of 0-1.
  • For Part B, have advanced solid tumors with specific pathogenic molecular alterations (YES1, TYMS amplification, FAT1 mutation in NSCLC; NF2 mutation in renal cancer or mesothelioma; or NF2, FAT1, LATS1 mutation or TYMS, YAP1, YES1, TAZ1 amplification in other solid tumors).
  • Have received 1-3 prior therapies appropriate for their tumor type and stage (Part B).
Not Eligible

You will not qualify if you...

  • Have known HER2+ overexpressing malignancies (Part A).
  • Have received radiotherapy (except palliative), endocrine therapy, chemotherapy, or investigational agents within 28 days (42 days for nitrosoureas, mitomycin-C) prior to first dose.
  • Have ongoing toxic effects from previous treatments above Grade 2, except alopecia and neuropathy.
  • Have treated brain metastases with progression within 28 days after CNS-directed therapy.
  • Female subjects who are pregnant, lactating, or can become pregnant without a negative pregnancy test and use of effective contraception.
  • Male subjects with partners of childbearing potential who do not agree to use barrier contraception.
  • Have had major surgery from which they have not yet recovered.
  • Have certain cancer types with specific mutations excluded in Part B (e.g., colorectal cancer, glioma, melanoma, anaplastic thyroid with BRAF mutations; NSCLC with BRAF, EGFR, or HER2 alterations; breast, gastric, esophageal junction adenocarcinoma, or biliary cancer with HER2 alterations; anal, penile, cervical, or head and neck cancers with prior HPV infection).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 12 locations

1

Mayo Clinic

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States, 80218

Actively Recruiting

3

Mayo Clinic

Jacksonville, Florida, United States, 32224

Actively Recruiting

4

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

5

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

6

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

7

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

8

NEXT Oncology Houston

Houston, Texas, United States, 77054

Actively Recruiting

9

NEXT Oncology Dallas

Irving, Texas, United States, 75039

Actively Recruiting

10

NEXT Oncology Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

11

Western General Hospital - NHS Lothian

Edinburgh, United Kingdom, EH4 2XU

Completed

12

The Royal Marsden NHS Foundation and Trust

London, United Kingdom, SW3 6JJ

Completed

Loading map...

Research Team

E

Erin Belshaw

CONTACT

S

Shay Shemesh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here