Actively Recruiting
A Study of SIGX1094R in Patients With Advanced Solid Tumors
Led by Signet Therapeutics · Updated on 2026-05-14
102
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I clinical, first-in-human study of SIGX1094R monotherapy. The goal of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), anti-tumor activity and food effect of SIGX1094R in patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of SIGX1094R in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and voluntarily agree to participate by signing informed consent.
- 18 years of age or older, any gender.
- Histologically, cytologically, or clinically confirmed advanced solid tumors with no standard treatment available, disease progression after standard treatment, or intolerance to standard treatment.
- At least one evaluable tumor lesion according to RECIST v1.1, or evaluable lesions without measurable tumors as judged by the investigator.
- Willing to provide a pre-treatment tumor specimen (archival or fresh biopsy) unless the biopsy procedure poses a high risk.
- Eastern Oncology Collaborative Group (ECOG) performance status score of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate organ function including liver, kidney, hematology, and coagulation parameters as specified.
- Women of reproductive age must have a negative pregnancy test within 7 days before first dose and agree to use effective contraception or abstinence until 6 months after last dose; men must also agree to use effective contraception or abstinence for the same period.
You will not qualify if you...
- Hypersensitivity or severe allergy to SIGX1094R or its ingredients.
- History of a second primary malignant tumor except for certain cured or stable skin or cervical cancers.
- Receipt of cytotoxic chemotherapy or small molecule targeted drugs within 4 weeks prior to first dose (longer washout for some drugs).
- Receipt of anti-tumor endocrine therapy, radiotherapy, interventional therapies, immunotherapy, or other biotherapies within 4 weeks prior to first dose.
- Use of proprietary anti-tumor medicines within 2 weeks prior to first dose (China study only).
- Participation in other clinical trials with investigational drugs within 4 weeks or 5 half-lives prior to first dose.
- Previous treatment with focal adhesion kinase (FAK) inhibitors.
- Use of strong CYP3A4/3A5 or P-gp/BCRP inhibitors or inducers within 14 days prior to first dose or inability to stop during study.
- Use of anti-acid or gastric acid reducing agents within 14 days prior to first dose unless administration is spaced by at least 2 hours.
- Pregnancy or lactation.
- Unresolved adverse reactions from prior anti-tumor therapy except certain mild or stable toxicities.
- Symptomatic or uncontrolled central nervous system or meningeal metastases at screening.
- Severe neurological or psychiatric disorders.
- History of drug abuse or dependence.
- Clinically serious and uncontrolled cardiovascular diseases.
- Uncontrolled hyperglycemia at screening.
- Recent pulmonary embolism or interstitial pneumonia.
- Prior allogeneic stem cell, bone marrow, or vital organ transplantation.
- Recent major surgery or trauma within 4 weeks prior to first dose or not recovered from surgery.
- Uncontrolled infectious diseases, immunodeficiency, active hepatitis B or C, or active infections requiring IV antibiotics.
- Conditions affecting drug absorption such as dysphagia or prior small bowel resection.
- Active autoimmune diseases.
- Investigator judgment deeming patient unsuitable for participation due to mental disorders or poor compliance.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
S
Signet Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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