A Study of SIGX1094R in Patients With Advanced Solid Tumors (NCT06739291) | Clinical Trial Compass
RecruitingPhase 1
A Study of SIGX1094R in Patients With Advanced Solid Tumors
China102 participantsStarted 2024-12-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must be able to understand the procedures and methods of this clinical study, voluntarily participate in the study and sign the ICF.
. Patients aged ≥18 years when signing the ICF, male or female.
. Patients with histologically, cytologically, or clinically proven advanced solid tumors (locally advanced or metastatic) that do not have standard treatment available, have disease progression on/after standard treatment, or cannot tolerate standard treatment.
. Patients with at least one evaluable tumor lesion according to the RECIST v1.1; patients who have no measurable lesions but have evaluable lesions are allowed to be enrolled as judged by the investigator.
. Patients (according to patients' option) will provide a pre-treatment tumor specimen (archival or fresh biopsy samples). If a fresh biopsy is required, procedures more invasive than a core biopsy or significant risk procedures for which the procedure-associated absolute risk of mortality or major morbidity in the patient's clinical setting and specific institution is 2% or higher, should not be utilized. The tumor tissue is used for pFAK status confirmation, without restriction on enrollment.
. ECOG score ≤ 1.
. Life expectancy ≥ 3 months
. Patients with adequate organ function, including:
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs)
Timeframe: From the first dose to 28 days after the last dose. Last for approximately 18 months.
2
Incidence of serious adverse events (SAEs)
Timeframe: From the first dose to 28 days after the last dose. Last for approximately 18 months.
3
Abnormalities or changes in laboratory tests
Timeframe: Approximately 18 months
4
Abnormalities or changes in vital signs
Timeframe: Approximately 18 months
5
Abnormalities or changes in electrocardiograms (ECGs)
Timeframe: Approximately 18 months
6
Abnormalities or changes in physical examinations
Timeframe: Approximately 18 months
7
Abnormalities or changes in Eastern Oncology Collaborative Group (ECOG) scores
. Patients with hypersensitivity to the active ingredient or excipient ingredient of SIGX1094R, or a history of severe allergy.
. Having a history of a second primary malignant tumor, excluding cervical carcinoma in situ, cutaneous squamous cell carcinoma, or basal cell carcinoma that has been cured or stabilized as assessed by the investigator;
. Patients who have received cytotoxic chemotherapeutic drugs or small molecule targeted drugs within 4 weeks prior to the first dose. Note: For mitomycin C or nitrosoureas, 6-week washout is required; for small-molecule targeted drugs and oral fluorouracil drugs, a washout period of 2 weeks or 5 T1/2 of the drug (whichever is shorter) is required.
. Anti-tumor endocrine therapy, radiotherapy, interventional embolization, radiofrequency, proton therapy, radioimmunotherapy, immunotherapy or other biotherapies within 4 weeks prior to the first dose (if 5 T1/2 of the drug/therapy used by the patient is confirmed to be \< 4 weeks, 5 T1/2 shall prevail).
. Patients who have received anti-tumor treatment with medicine/proprietary medicine within 2 weeks prior to the first dose. Note: This criterion is relevant to China study only.
. Patients who have received other clinical investigational drugs or therapies that are not on the market within 4 weeks or 5 T1/2 prior to the first dose, whichever is longer.
. Prior treatment with focal adhesion kinase (FAK) inhibitors.
. Patients who have received strong cytochrome P450(CYP)3A4, CYP3A5 inhibitors, or strong CYP3A4 or CYP3A5 inducers, or strong P-gp and BCRP inhibitors, within 14 days prior to the first dose; or cannot stop using such drugs during the study.
8
Incidence of dose-limiting toxicity (DLT) events
Timeframe: From the first treatment of single dosing (5 days in single dosing period ) to the end of Cycle 1 (21 days a Cycle in multiple dosing period ).