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Advanced Solid TumorsPhase 1NCT06739291

A Study of SIGX1094R in Patients With Advanced Solid Tumors

A Phase 1 study testing SIGX1094R in people with Advanced Solid Tumors, run by Signet Therapeutics at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SIGX1094R
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteChina
Study dates
12 Dec 2024to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following criteria before being enrolled in the study.
  • 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.
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  • ECOG score ≤ 1.
  • Life expectancy ≥ 3 months
  • Patients with adequate organ function, including:
  • Liver function (no history of liver protection therapy 7 days before screening): total bilirubin (TBIL) ≤ 1.5×ULN, alanine aminotransferase (ALT)
  • 3×ULN, aspartate aminotransferase (AST) ≤ 3×ULN (no liver metastasis); if there is liver metastasis, ALT and AST ≤ 5×ULN; albumin ≥ 30 g/L.
  • Renal function: Creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula).
  • Hematology (no blood transfusion or hematopoietic stimulating factor treatment within 14 days; no treatment with erythropoietin or thrombopoietin within 7 days): absolute neutrophil count (ANC) ≥ 1.5×10^9/L, platelet (PLT) ≥ 100×10^9/L, and hemoglobin (Hb) ≥ 90 g/L.
  • Coagulation function: activated partial thromboplastin time ≤ 1.5 × ULN and international normalized ratio ≤ 1.5 × ULN.
  • Women of reproductive age must have a negative blood pregnancy test result within 7 days prior to the first dose and promise to adhere to fully effective contraception or abstinence from the beginning of the screening period until 6 months after the last dose of study treatment; male patients must promise to adhere to fully effective contraception or abstinence from the beginning of the screening period until 6 months after the last dose of study treatment.

Who cannot join

  • Patients who meet any of the following criteria cannot be enrolled in this study.
  • 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.
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  • 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.
  • Patients who have received an anti-acid drug or gastric acid reducing agents within 14 days prior to the first dose and cannot be discontinued for the duration of the study. Allow enrollment if administration interval between antacids/gastric acid inhibitors and the study drug is no less than 2 hours during the study period.
  • Pregnant or lactating women.
  • Patients whose adverse reactions of prior anti-tumor therapy assessed according to CTCAE v5.0 at the time of screening have not returned to Grade ≤ 1 (except for toxicities that are of no safety risk as judged by the investigator, such as alopecia, gasping, γ-glutamyl transferase (GGT) increased, Alkaline phosphatase (ALP) increased, grade 2 peripheral neurotoxicity, and decreased thyroid function stabilized by hormone replacement therapy).
  • Presence of clinically symptomatic metastases to central nervous system or meninges or other evidence showing that metastatic lesions in central nervous system or meninges have not yet been controlled at screening, which, at the investigator's discretion, is not suitable for enrollment. Note: Patients with central nervous system or meningeal metastases who are asymptomatic or stable after treatment prior to the first dose may be considered for enrollment.
  • A history of severe neurological or psychiatric disorders, including epilepsy, dementia, and moderate to severe depression.
  • History of drug abuse or dependence.
  • Clinically serious and uncontrolled cardiovascular diseases.
  • Patients with hyperglycemia that cannot be stably controlled with medication at screening.
  • Patients with pulmonary embolism within 6 months prior to the first dose, or interstitial pneumonia at screening.
  • Prior allogeneic stem cell transplantation, bone marrow transplantation or vital organ transplantation.
  • Patients who have undergone surgery on vital organs (other than aspiration biopsy) or suffered major trauma within 4 weeks prior to the first dose, or patients who have not recovered from any surgical effect at screening, or who are scheduled for major surgery during the study period.
  • Patients with uncontrolled infectious diseases, congenital immunodeficiency diseases, acquired immunodeficiency syndrome [human immunodeficiency virus antibody (HIV-Ab) positive], syphilis (syphilis antibody-positive), or active hepatitis B [hepatitis B virus (HBV) - deoxyribonucleic acid (DNA) >500 IU/ml]; hepatitis C virus (HCV) infection (HCV antibody positive and HCV ribonucleic acid amplification quantitative test positive). Patients with well controlled HIV, HBV, and HCV infections may be enrolled with no significant safety risk in the judgment of the investigator; see https://www.fda.gov/media/121319/download for definition of well controlled.
  • Patients with severe active infection, including but not limited to bacteremia and severe pneumonia within 2 weeks prior to the first dose; patients with an active infection requiring intravenous antibiotics within 2 weeks prior to the first dose.
  • Patients with conditions that may affect drug absorption as judged by the investigator, such as dysphagia, chronic diarrhea, or prior small bowel resection.
  • Patients with active autoimmune diseases, such as rheumatic disorder and rheumatoid disease.
  • The investigator considers that the patient is not suitable for participating in this study (e.g., study drug is not in the best interest of patient, patients with mental disorder, patients with poor compliance, etc.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Signet Therapeutics contact

0086 0755-82571742

yufang.chen@signettx.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing

    BEIJING CANCER HOSPITAL, 0086 010-88196561, doctorshenlin@sina.cn

    Shen Lin

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Anti-tumor Activity and Food Effect of SIGX1094R in Patients With Advanced Solid Tumors

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.

Read the detailed description

The study consists of two parts: SIGX1094R dose escalation study; food effect and SIGX1094R multiple-dose expansion study.

Part of SIGX1094R dose escalation study:

  • the primary objective is to evaluate the safety and tolerability of SIGX1094R, and to define the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D).
  • the secondary objective is to evaluate the PK profile and preliminary efficacy of SIGX1094R, and to explore the relationship between PD parameters and efficacy.

Part of food effect and SIGX1094R multiple-dose expansion study:

  • the primary objective is to evaluate the food effect on PK profile of SIGX1094R.
  • the secondary objective is to further evaluate the anti-tumor activity, safety and tolerability of SIGX1094R, and to further evaluate the relationship between PD parameters and efficacy.
Being tested
SIGX1094R
Keywords
Focal Adhesion Kinase inhibitor, FAK inhibitor, SIGX1094R

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIGX1094RDrug

    Single drug treatment by SIGX1094R, orally administered once daily.

Study groups in NCT06739291
Study groupRoleWhat they receive
SIGX1094RExperimentalOral SIGX1094R administered once daily.
Receives: Drug: SIGX1094R

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    To evaluate the safety and tolerability of SIGX1094R. AEs will be evaluated per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE),Version 5.0.

    Measured: From the first dose to 28 days after the last dose. Last for approximately 18 months.

  2. Incidence of serious adverse events (SAEs)

    To evaluate the safety and tolerability of SIGX1094R. SAEs will be evaluated per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE),Version 5.0.

    Measured: From the first dose to 28 days after the last dose. Last for approximately 18 months.

  3. Abnormalities or changes in laboratory tests

    To evaluate the safety and tolerability of SIGX1094R.

    Measured: Approximately 18 months

  4. Abnormalities or changes in vital signs

    To evaluate the safety and tolerability of SIGX1094R.

    Measured: Approximately 18 months

  5. Abnormalities or changes in electrocardiograms (ECGs)

    To evaluate the safety and tolerability of SIGX1094R.

    Measured: Approximately 18 months

  6. Abnormalities or changes in physical examinations

    To evaluate the safety and tolerability of SIGX1094R.

    Measured: Approximately 18 months

  7. Abnormalities or changes in Eastern Oncology Collaborative Group (ECOG) scores

    To evaluate the safety and tolerability of SIGX1094R.

    Measured: Approximately 18 months

  8. Incidence of dose-limiting toxicity (DLT) events

    Collect the incidence, classification, severity, and frequency of DLT. To evaluate the safety and tolerability of SIGX1094R.

    Measured: 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 ).

  9. Maximum tolerated dose (MTD)

    To determine the MTD of SIGX1094R.

    Measured: Approximately 18 months

  10. Recommended phase 2 dose (RP2D)

    To determine the RP2D of SIGX1094R.

    Measured: Approximately 18 months

Secondary outcomes (11)

  1. Maximum observed concentration (Cmax)

    To assess pharmacokinetics (PK) of SIGX1094R in plasma following a single and multiple doses of SIGX1094R.

    Measured: Time points at Day 1 to Day 5 in single-dose period. Time points at Cycle 1 Day1, Cycle 1 Day 8, Cycle 1 Day15, Cycle 1 Day 21 in Cycle 1, and Cycle n Day 1 from Cycle 2, in multiple-dose period. Each Cycle is 21 days.

  2. Time of maximum observed concentration (Tmax)

    To assess PK of SIGX1094R in plasma following a single and multiple doses of SIGX1094R.

    Measured: Time points at Day 1 to Day 5 in single-dose period. Time points at Cycle 1 Day1, Cycle 1 Day 8, Cycle 1 Day15, Cycle 1 Day 21 in Cycle 1, and Cycle n Day 1 from Cycle 2, in multiple-dose period. Each Cycle is 21 days.

  3. Area under the concentration-time curve (AUC)

    To assess PK of SIGX1094R in plasma following a single and multiple doses of SIGX1094R.

    Measured: Time points at Day 1 to Day 5 in single-dose period. Time points at Cycle 1 Day1, Cycle 1 Day 8, Cycle 1 Day15, Cycle 1 Day 21 in Cycle 1, and Cycle n Day 1 from Cycle 2, in multiple-dose period. Each Cycle is 21 days.

  4. Half-life (t1/2)

    To assess PK of SIGX1094R in plasma following a single and multiple doses of SIGX1094R.

    Measured: Time points at Day 1 to Day 5 in single-dose period. Time points at Cycle 1 Day1, Cycle 1 Day 8, Cycle 1 Day15, Cycle 1 Day 21 in Cycle 1, and Cycle n Day 1 from Cycle 2, in multiple-dose period. Each Cycle is 21 days.

  5. Objective response rate (ORR)

    Proportion of subjects whose best response is observed to be complete response (CR) or partial response (PR) throughout the study. Assessed by RECIST 1.1 criteria.

    Measured: Approximately 18 months

  6. Progression-free survival (PFS)

    Time from Day 1 of treatment with the study drug to progressive disease (PD) or death from any cause. Assessed by RECIST 1.1 criteria.

    Measured: Approximately 18 months

  7. Duration of response (DOR)

    Time from first tumor assessment of CR or PR on study treatment to first assessment of PD or death due to any cause. Assessed by RECIST 1.1 criteria.

    Measured: Approximately 18 months

  8. Overall survival (OS)

    Time from Day 1 of treatment with the study drug to death from any cause. Assessed by RECIST 1.1 criteria.

    Measured: Approximately 18 months

  9. Disease control rate (DCR)

    Proportion of subjects whose best response is observed to be CR, PR, or stable disease (SD) (duration ≥ 12 weeks) throughout the study. Assessed by RECIST 1.1 criteria.

    Measured: Approximately 18 months

  10. Clinical benefit rate (CBR)

    Proportion of subjects whose best response is observed to be CR, PR, or SD (duration ≥ 24 weeks) throughout the study.

    Measured: Approximately 18 months

  11. Changes of phosphorylated Focal Adhesion Kinase (pFAK) in tumor tissues

    Determine the changes of phosphorylated Focal Adhesion Kinase (pFAK) from baseline in tumor tissues and assess its relationship with efficacy.

    Measured: Baseline to approximately 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start12 Dec 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06739291
Sponsor's protocol ID
SG-SIGX1094R-CT-001
Status last verified
May 2026
First submitted
6 Dec 2024
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SIGX1094R in people with Advanced Solid Tumors, run by Signet Therapeutics at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Signet Therapeutics (0086 0755-82571742, yufang.chen@signettx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: From the first dose to 28 days after the last dose. Last for approximately 18 months.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06739291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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