Solid TumorsPhase 1/2NCT06224387
CTS2190 Phase I /II Clinical Study in Patients
A Phase 1/2 study testing CTS2190 capsules in people with Solid Tumors and Pancreatic Cancer, run by CytosinLab Therapeutics Co., Ltd. at 2 sites in China.
Trial summary
This is a first in human study in patients with advanced or metastatic solid tumors. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific tumor types. The study drug, CTS2190, is a PRMT1 inhibitor administered orally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Pancreatic Cancer, Non-small Cell Lung Cancer
- What is being tested?
- CTS2190 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesChina
- Study dates
- 26 Jun 2023to 31 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Subjects who meet all of the following criteria can be included in this study:
- Male or female ≥ 18 years of age at signing of ICF.
- Part 1: histologically or cytologically confirmed locally advanced or metastatic solid tumors at screening who cannot be treated surgically and have failed standard treatment (PD during treatment or after the last treatment) recommended by the current clinical diagnosis and treatment standards or guidelines, or cannot tolerate standard treatment, or refuse standard treatment and/or currently have no effective treatment available.
- Part 2: histologically or cytologically confirmed advanced solid tumors (including pancreatic cancer, non-small cell lung cancer and/or other tumors, such as gastric cancer, colorectal cancer, etc.) at screening who cannot be treated surgically and have failed standard treatment (PD during treatment or after the last treatment) recommended by the current clinical diagnosis and treatment standards or guidelines, or cannot tolerate standard treatment, or refuse standard treatment and/or currently have no effective standard treatment available.
- At least one measurable tumor lesion at screening [according to RECIST V1.1 criteria (see appendix 1)].
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (Appendix 2) at screening.
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- With a life expectancy ≥ 12 weeks at screening.
- With good organ function at screening, including:
- Liver function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (if the following conditions occur, isolated bilirubin >1.5 × ULN is acceptable if: bilirubin is fractionated and direct bilirubin <35%, or the patients is diagnosed with Gilbert syndrome), alanine aminotransferase (ALT) ≤ 2.5 × ULN, and aspartate aminotransferase (AST) ≤ 2.5 × ULN (for patients with liver metastases or tumor infiltration, the criteria can be relaxed to TBIL ≤ 1.5 × ULN, ALT ≤5 × ULN, and AST ≤ 5 × ULN);
- Renal function: blood creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min [calculate the creatinine clearance using Cockcroft-Gault formula (appendix 3)];
- Hematology: platelet ≥ the lower limit of the laboratory normal range, and absolute neutrophil count (ANC) ≥ 1.5 × 109/L, and hemoglobin ≥ 100 g/dL;
- Cardiac function: QT interval corrected by Fridericia method (QTcF) ≤ 450 ms (male) or ≤ 470 ms (female) (see the appendix 3 for calculation formula).
- Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Female patients of non-childbearing age or female patients of childbearing age who have negative pregnancy test results and promise to take sufficient and effective contraceptive measures or adhere to abstinence from the screening period to 90 days after the last administration, or male patients who promise to take sufficient and effective contraceptive measures or adhere to abstinence from the screening period to 90 days after the last administration (see the appendix 4). Patients are not allowed to donate sperm within 6 months from the start of administration to 6 months after the end of investigational drug administration.
- Patients who understand and voluntarily signs the ICF, are willing to and able to complete the scheduled visits, treatment plan, laboratory tests and other study procedures.
Who cannot join
- Subjects should not participate in this clinical study if any of the following conditions is met:
- Female patients in pregnancy or lactation.
- Patients with dysphagia.
- Patients who cannot tolerate venipuncture or have a history of syncope judged by the investigator to be clinically significant.
- Uncontrolled tumor-related pain.
- Allergic or intolerant to the active ingredients or excipients of the investigational drug judged by the investigator.
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- Treatment with radiotherapy for the target lesion within 4 weeks before the first administration of the investigational drug, or accepted any anti-tumor drugs/ treatments (including but not limited to chemotherapy, targeted therapy, immunotherapy) within 5 half-lives before the first administration of the investigational drug, whichever is longer; or patients who have received herbal therapies with anti-tumor indications within 1 week before the first administration.
- Primary central nervous system (CNS) tumor or CNS metastasis at screening. The following patients can be considered for enrollment: after treatment and being stable for ≥ 3 months, patients who have completed the treatment at least 10 days before the start of the study treatment; the corticosteroid treatment has been terminated for ≥ 5 days when the study treatment starts, the neurological function is stable, and it is estimated that no steroids or antiepileptic drugs will be required during the study treatment.
- Patients judged by the investigator to have uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion (requiring repeated drainage, multiple times a month or more frequently) at screening. Allow patients to indwell catheters regardless of drainage frequency.
- Patients with untreated or clinically symptomatic spinal cord compression that has not been controlled (except for patients who have received treatment and have stable symptoms, whose imaging examination shows that they are stable for at least 4 weeks before the first administration, and who have no evidence of brain edema and do not require glucocorticoid treatment).
- Patients with ≥ 2 malignant tumors within 5 years before the first administration. Except for cured early-stage malignancies (carcinoma in situ or stage I tumor), such as adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer.
- Patients who are found to have active pulmonary tuberculosis infection within 1 year before enrollment through medical history, or those with a history of active pulmonary tuberculosis infection more than one year ago who have not received formal treatment.
- Interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia (i.e., affecting activities of daily living or requiring intervention).
- Severe infection within 4 weeks before the first administration, including but not limited to bacteremia and severe pneumonia, etc. requiring hospitalization; CTCAE ≥ grade 2 active infection requiring systemic antibiotic treatment within 2 weeks before the first administration.
- History of serious cardiovascular and cerebrovascular diseases, including but not limited to serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree II-III atrioventricular block, etc.; acute coronary syndrome, congestive cardiac failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events within 6 months before the first administration; New York Heart Association (NYHA) cardiac function classification (see appendix 5) ≥ grade II or left ventricular ejection fraction (LVEF)<50% or hypertension that cannot be clinically controlled (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).
- Positive hepatitis B virus surface antigen (HBsAg) and the number of copies of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (or 2500 copies, or the lower limit of the positive detection value of the study site) at screening, HBsAg (-), hepatitis B core antibody (HBcAb) (+) and the number of copies of HBV DNA≥ 500 IU/mL (or 2500 copies, or the lower limit of the positive detection value of the study site) after treatment of HBV infection, or positive hepatitis C antibody (HCVAb) and hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ ULN of the study site; those with a history of liver cirrhosis (Child Pugh class B or C) or active syphilis infection.
- Patients who have active diseases or a history of autoimmune diseases that may relapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) at screening, except patients suffering clinically stable autoimmune thyroid disorder.
- History of immunodeficiency, including HIV positive, or those suffering from other acquired or congenital immunodeficiency diseases, or with a history of allograft. Autotransplantation should be completed at least 3 months before screening.
- Those who had clinically significant hemorrhage symptoms within 3 months before the first administration. Patients who significantly coughed up blood within 4 weeks before the first administration of the investigational drug, and the amount of hemoptysis each time reached half a teaspoon (2.5 mL) or more; patients who had arterial/venous thrombosis events within 6 months before the first administration, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, central retinal vein occlusion (RVO), etc.; those who are receiving anticoagulant treatment at the time of screening; patients with potential thrombosis or at the risk of coagulation judged by the investigator.
- Patients who have received other unlisted clinical investigational drugs or treatments within 4 weeks (or 5 drug half-lives, whichever is longer) before the first administration.
- Patients who have used live vaccine or attenuated vaccine within 4 weeks before the first administration, or plan to use live vaccine or attenuated vaccine during the study period.
- Patients who have used potent cytochrome enzyme (CYP)3A4 inhibitors or inducers within 2 weeks before the first administration, or need to use potent CYP3A4 inhibitors or inducers until 7 days after the last dose (see the appendix 6).
- Major surgery (except for surgery for diagnostic purposes) within 4 weeks before the first administration, or expected to undergo major surgery (except for surgery for diagnostic purposes) during the study period, or have undergone diagnostic or minimally invasive surgery within 7 days before the first administration.
- Adverse reactions from previous anti-tumor treatment have not recovered to ≤ CTCAE V5.0 grade 1 (except for alopecia and grade 2 neurotoxicity caused by chemotherapy drugs, grade 2 hypothyroidism caused by anti-tumor treatments, hypertension and other toxicities that are judged to have no safety risks by the investigator).
- Patients who are judged by the investigator to have a history of other serious systemic diseases, or not suitable for participating in the trial for any other reason (the patient has mental illness, alcohol abuse, drug use or drug abuse that may affect his/her compliance with the trial or may interfere with the interpretation of the study results).
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Cheng X Dong, PHD, 13968032995 ext. 86-10, Chengxd516@126.com
Song Z Bo, PHD, 13857153345 ext. 86-10, songzb@zjcc.org.cn
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
yao J, Doctor, 136 6379 0098, yaojun74@163.com
yang J Q, Doctor
About this study
Official title: A Multi-center, Open-label, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CTS2190 in Patients With Solid Tumors
This is a first in human study in patients with advanced or metastatic solid tumors. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific tumor types. The study drug, CTS2190, is a PRMT1 inhibitor administered orally. The study is planned to treat up to 224 participants.
Read the detailed description
This is a Phase 1/2 multi-center, open label study in solid tumor patients. Phase 1（Part1) is a dose escalation study of oral CTS2190 in patients with solid tumors，which is planned to treat up to 144 participants.
Phase 2（Part2) is an open label, dose expansion study in specific tumor types. In both parts of the study, participants who tolerate the drug may continue the treatment until disease progression.
The study duration for each subject is defined as beginning from 28 days prior to the first dose, until the subject withdrawal of informed consent, end of treatment, loss to follow-up or death, completes 48 weeks of continuous treatment or the study ends early, whichever occurs first. The end of study is defined as the date when the last subject completes the last visit specified in the protocol.
- Conditions
- Solid Tumors, Pancreatic Cancer, Non-small Cell Lung Cancer, Triple-negative Breast Cancer
- Being tested
- CTS2190 capsules
- Keywords
- Phase I/II, pharmacodynamic, Pharmacokinetics, Tolerability
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTS2190 capsulesDrug
Also called CTS2190
4-6 dose groups are pre-specified in Dose Escalation,and 4 arms in Dose Expansion.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation/Dose Expansion | Experimental | 4-6 dose groups are pre-specified in Dose Escalation,and 4 arms in Dose Expansion. Receives: Drug: CTS2190 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation：The maximum tolerated dose (MTD)
The MTD is defined as the dose level at which the DLT rate is closest to the target toxicity incidence (i.e., 0.3) during the DLT observation period (within 25 days after the first administration).
Measured: During the DLT observation period: 25 days after the first administration
Dose Escalation：The recommended phase 2 dose (RP2D)
The recommended phase 2 dose (RP2D) of CTS2190 Based on the review of all available data including, but not limited to, safety, tolerability, PK, PD and preliminary anti-tumor activity, RP2D may be determined.
Measured: During the DLT observation period: 25 days after the first administration
Dose Expansion：Objective response rate(ORR)
The percentage of participants having complete response (CR) or partial response (PR))assessed based on RECIST V1.1.
Measured: Every 6 weeks for the duration of study participation.
Secondary outcomes (25)
Pharmacokinetic (PK) characteristics:Peak concentration(Cmax)
Peak concentration of CTS2190 in patients with solid tumors
Measured: Day1 to Day 4 Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics: time to peak concentration (Tmax)
time to peak concentration of CTS2190 in patients with solid tumors
Measured: Single-dose stage: Day1 to Day 4; Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day1.
Pharmacokinetic (PK) characteristics：area under concentration-time curve from zero to infinity (AUC0-∞)
area under concentration-time curve from zero to infinity of CTS2190 in patients with solid tumors
Measured: Single-dose stage: Day 1 to Day 4, Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 D 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：area under concentration-time curve from zero to time of the last detectable concentration (AUC0-t)
area under concentration-time curve from zero to time of the last detectable concentration of CTS2190 in patients with solid tumors
Measured: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：elimination half-life (T1/2)
elimination half-life (T1/2) of CTS2190 in patients with solid tumors
Measured: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：apparent clearance (CL/F)
apparent clearance (CL/F) of CTS2190 in patients with solid tumors
Measured: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：apparent volume of distribution (Vz/F)
apparent volume of distribution (Vz/F) of CTS2190 in patients with solid tumors
Measured: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：mean residence time (MRT)
mean residence time (MRT) of CTS2190 in patients with solid tumors
Measured: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：area under concentration-time curve from time of the last administration to the last detectable concentration (AUC0-t,ss)
area under concentration-time curve from time of the last administration to the last detectable concentration (AUC0-t,ss) of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：area under concentration-time curve from time of last administration to infinity (AUC0-∞,ss)
area under concentration-time curve from time of last administration to infinity (AUC0-∞,ss) of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：time to steady-state peak concentration (Tmax, ss)
time to steady-state peak concentration (Tmax, ss) of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state peak concentration (Cmax,ss)
steady-state peak concentration (Cmax,ss) of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state trough concentration (Css trough)
steady-state trough concentration (Css trough) of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state elimination half-life (T1/2, ss)
steady-state elimination half-life (T1/2, ss) of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state elimination rate constant (λz,ss)
steady-state elimination rate constant (λz,ss) of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state apparent clearance (CL/F,ss)
steady-state apparent clearance (CL/F,ss) of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state apparent volume of distribution (V/F,ss)
steady-state apparent volume of distribution (V/F,ss) of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：accumulation indexes Rac,Cmax and Rac,AUC
accumulation indexes Rac,Cmax and Rac,AUC of CTS2190 in patients with solid tumors
Measured: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Dose Expansion：Objective response rate (ORR)
Objective response rate (ORR) assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.
Measured: Every 6 weeks for the duration of study participation
Incidence of TEAEs and SAEs
Before and after treatment, clinically significant changes in vital signs, physical examination, laboratory tests, 12-lead ECG and other safety measures.
Measured: Baseline through 28 days after end of treatment, estimated up to 48 weeks
Duration of response (DOR)
Duration of response (DOR) assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.
Measured: Every 6 weeks for the duration of study participation
Disease control rate (DCR)
disease control rate (DCR) assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.
Measured: Every 6 weeks for the duration of study participation
Progression-free survival (PFS)
progression-free survival (PFS) assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.
Measured: Every 6 weeks for the duration of study participation
Pharmacodynamic (PD) characteristics of CTS2190 : asymmetric dimethylarginine (ADMA)
To explore the changes of asymmetric dimethylarginine (ADMA) in blood of patients with solid tumors before and after administration of CTS2190 and their correlation with the efficacy of CTS2190.
Measured: Single-dose stage:Day 1; Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day1, Cycle 1 Day 8, Cycle 1 Day 15 and Cycle 3 Day 1
Pharmacodynamic (PD) characteristics of CTS2190 : monomethyl arginine (MMA)
To explore the changes of monomethyl arginine (MMA) in blood of patients with solid tumors before and after administration of CTS2190 and their correlation with the efficacy of CTS2190.
Measured: Single-dose stage:Day 1; Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and Cycle 3 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start26 Jun 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- QD and durg holiday,PO.
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytosinLab Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wu H P, Docotor, Study chair, CytosinLab Therapeutics Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224387
- Sponsor's protocol ID
- CTS2190-CI01
- Status last verified
- Aug 2024
- First submitted
- 7 May 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CTS2190 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT06224387
- Acronym / sponsor ID
- CTS2190-CI01
- Conditions
- Solid Tumors, Pancreatic Cancer, Non-small Cell Lung Cancer, Triple-negative Breast Cancer
- Keywords
- Phase I/II, pharmacodynamic, Pharmacokinetics, Tolerability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- CytosinLab Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first in human study in patients with advanced or metastatic solid tumors. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific tumor types. The study drug, CTS2190, is a PRMT1 inhibitor administered orally. The study is planned to treat up to 224 participants.
Detailed description
This is a Phase 1/2 multi-center, open label study in solid tumor patients. Phase 1（Part1) is a dose escalation study of oral CTS2190 in patients with solid tumors，which is planned to treat up to 144 participants.
Phase 2（Part2) is an open label, dose expansion study in specific tumor types. In both parts of the study, participants who tolerate the drug may continue the treatment until disease progression.
The study duration for each subject is defined as beginning from 28 days prior to the first dose, until the subject withdrawal of informed consent, end of treatment, loss to follow-up or death, completes 48 weeks of continuous treatment or the study ends early, whichever occurs first. The end of study is defined as the date when the last subject completes the last visit specified in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- QD and durg holiday,PO.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation/Dose Expansion | Experimental | Drug: CTS2190 capsules4-6 dose groups are pre-specified in Dose Escalation,and 4 arms in Dose Expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female ≥ 18 years of age at signing of ICF.
- Part 1: histologically or cytologically confirmed locally advanced or metastatic solid tumors at screening who cannot be treated surgically and have failed standard treatment (PD during treatment or after the last treatment) recommended by the current clinical diagnosis and treatment standards or guidelines, or cannot tolerate standard treatment, or refuse standard treatment and/or currently have no effective treatment available.
- Part 2: histologically or cytologically confirmed advanced solid tumors (including pancreatic cancer, non-small cell lung cancer and/or other tumors, such as gastric cancer, colorectal cancer, etc.) at screening who cannot be treated surgically and have failed standard treatment (PD during treatment or after the last treatment) recommended by the current clinical diagnosis and treatment standards or guidelines, or cannot tolerate standard treatment, or refuse standard treatment and/or currently have no effective standard treatment available.
- At least one measurable tumor lesion at screening [according to RECIST V1.1 criteria (see appendix 1)].
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (Appendix 2) at screening.
Key exclusion criteria (25 listed)
- Subjects should not participate in this clinical study if any of the following conditions is met:
- Female patients in pregnancy or lactation.
- Patients with dysphagia.
- Patients who cannot tolerate venipuncture or have a history of syncope judged by the investigator to be clinically significant.
- Uncontrolled tumor-related pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTS2190 capsulesAlso: CTS21904-6 dose groups are pre-specified in Dose Escalation,and 4 arms in Dose Expansion. | Drug | Dose Escalation/Dose Expansion |
Primary outcome
Dose Escalation：The maximum tolerated dose (MTD)
Time frame: During the DLT observation period: 25 days after the first administration
The MTD is defined as the dose level at which the DLT rate is closest to the target toxicity incidence (i.e., 0.3) during the DLT observation period (within 25 days after the first administration).
Dose Escalation：The recommended phase 2 dose (RP2D)
Time frame: During the DLT observation period: 25 days after the first administration
The recommended phase 2 dose (RP2D) of CTS2190 Based on the review of all available data including, but not limited to, safety, tolerability, PK, PD and preliminary anti-tumor activity, RP2D may be determined.
Dose Expansion：Objective response rate(ORR)
Time frame: Every 6 weeks for the duration of study participation.
The percentage of participants having complete response (CR) or partial response (PR))assessed based on RECIST V1.1.
25 secondary outcomes
Pharmacokinetic (PK) characteristics:Peak concentration(Cmax)
Time frame: Day1 to Day 4 Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics: time to peak concentration (Tmax)
Time frame: Single-dose stage: Day1 to Day 4; Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day1.
Pharmacokinetic (PK) characteristics：area under concentration-time curve from zero to infinity (AUC0-∞)
Time frame: Single-dose stage: Day 1 to Day 4, Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 D 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：area under concentration-time curve from zero to time of the last detectable concentration (AUC0-t)
Time frame: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：elimination half-life (T1/2)
Time frame: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：apparent clearance (CL/F)
Time frame: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：apparent volume of distribution (Vz/F)
Time frame: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：mean residence time (MRT)
Time frame: single-dose stage: Day 1 to Day 4
Pharmacokinetic (PK) characteristics：area under concentration-time curve from time of the last administration to the last detectable concentration (AUC0-t,ss)
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：area under concentration-time curve from time of last administration to infinity (AUC0-∞,ss)
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：time to steady-state peak concentration (Tmax, ss)
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state peak concentration (Cmax,ss)
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state trough concentration (Css trough)
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state elimination half-life (T1/2, ss)
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state elimination rate constant (λz,ss)
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state apparent clearance (CL/F,ss)
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：steady-state apparent volume of distribution (V/F,ss)
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Pharmacokinetic (PK) characteristics：accumulation indexes Rac,Cmax and Rac,AUC
Time frame: Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 3 Day 1 and Cycle 5 Day 1
Dose Expansion：Objective response rate (ORR)
Time frame: Every 6 weeks for the duration of study participation
Incidence of TEAEs and SAEs
Time frame: Baseline through 28 days after end of treatment, estimated up to 48 weeks
Duration of response (DOR)
Time frame: Every 6 weeks for the duration of study participation
Disease control rate (DCR)
Time frame: Every 6 weeks for the duration of study participation
Progression-free survival (PFS)
Time frame: Every 6 weeks for the duration of study participation
Pharmacodynamic (PD) characteristics of CTS2190 : asymmetric dimethylarginine (ADMA)
Time frame: Single-dose stage:Day 1; Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day1, Cycle 1 Day 8, Cycle 1 Day 15 and Cycle 3 Day 1
Pharmacodynamic (PD) characteristics of CTS2190 : monomethyl arginine (MMA)
Time frame: Single-dose stage:Day 1; Multiple-dose stage: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and Cycle 3 Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu H P, Docotor study chair
CytosinLab Therapeutics Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CTS2190 capsules in people with Solid Tumors and Pancreatic Cancer, run by CytosinLab Therapeutics Co., Ltd. at 2 sites 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xing S N, Master (13816824670 ext. 201201, shuning.xing@cytosinlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation：The maximum tolerated dose (MTD) (time frame: During the DLT observation period: 25 days after the first administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2024.