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Advanced Malignant TumorsPhase 1NCT05728541

Dose Escalation and Expansion Study of SYH2043 in Patients With Advanced Malignant Tumors

A Phase 1 study testing SYH2043 in people with Advanced Malignant Tumors, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SYH2043 in patients with advanced malignant tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Tumors
What is being tested?
SYH2043
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
1 siteChina
Study dates
1 Mar 2023to 1 Mar 2026
Phase
Phase 1
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients aged 18-75 years (inclusive);
  • 2. Histological or cytological confirmation of advanced malignant tumors;
  • 3. Patients who failed or were intolerant to standard treatment or had no standard treatment, and meet the criteria as below of the corresponding stages:
  • Part A and PK Expansion Stage of part B: advanced malignant tumors;
  • Cohort extension of part B: solid tumors such as locally advanced/metastatic breast cancer, relapsed/refractory ovarian cancer, locally advanced/metastatic liver cancer, etc;
  • Part C and D: locally advanced/metastatic breast cancer with histological confirmation of ER+, HER2-;
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  • 4. With at least one measurable lesion according to RECIST v1.1;
  • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
  • 6. Life expectancy greater than 3 months;
  • 7. Main organs meet the following criteria within 7 days before treatment:
  • Hematology: no component blood transfusion, human granulocyte colony-stimulating factor (G-CSF), and erythropoietin (EPO) within 2 weeks prior to the investigational drug administration
  • Absolute neutrophil count (ANC) ≥1.5×10^9/L;
  • Platelet count (PLT) ≥90×10^9/L;
  • Hemoglobin (HGB) ≥90 g/L or ≥5.6 mmol/L;
  • Renal Function: Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 50 mL/min;
  • Liver function: Total bilirubin (TBIL) ≤ 1.5×ULN, or ≤ 3×ULN for patients with Gilbert syndrome; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤ 2.5×ULN, or ≤ 5×ULN in case of liver metastases;
  • Coagulation Function: Activated partial thromboplastin time (APTT)≤ 2×ULN; International normalized ratio (INR)≤ 2×ULN;
  • 8. The serum pregnancy test for women of childbearing potential (WOCBP) is negative within 7 days prior to the first dose of the investigational drug. Patient and his/her spouse must agree to take adequate contraception from signing of ICF to 6 months after the last dose, during which women should be non-lactating and men should refrain from donating sperms;
  • 9. Patients voluntarily participate in this clinical study, understand the study procedures and sign the ICF.

Who cannot join

  • 1. Have received anti-tumor treatments such as chemotherapy, radiotherapy, endocrine therapy, targeted therapy, immunotherapy, etc. within 4 weeks before the first dose of the investigational drug;
  • 2. Have received other unmarketed clinical investigational drugs or treatments within 4 weeks before the first dose of the investigational drug;
  • 3. Have received major surgery (excluding needle biopsy), or severe unhealed wounds, trauma, etc. within 4 weeks before the first dose of the investigational drug in the study;
  • 4. Have received glucocorticoids for systemic therapy over 7 days (Prednisone>10 mg/day or equivalent doses) or other immunosuppressant within 2 weeks before the first dose of investigational drug, and patients who need long-term use these therapies;
  • 5. Have received potent inhibitors or inducers of CYP3A4 and inhibitors of P-gp within 1 weeks before the first dose of the investigational drug;
  • 6. The adverse events due to previous anti-tumor treatments without recovering to Grade 1 (except for alopecia; some toxicities may be excluded as judged by the investigator) according to NCI-CTCAE v5.0;
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  • 7. Breast cancer patients with visceral crisis or symptomatic visceral metastasis;
  • 8. With active central nervous system (CNS) metastasis and/or cancerous meningitis;
  • 9. Active HBV or HCV infection (HbsAg positive and/or HBcAb positive with HBV DNA ≥ 2000 IU/mL, and HCVAb positive with HCV RNA positive), or HIV positive;
  • 10. Participants with a history of severe cardiovascular disease;
  • 11. Inability to swallow medications orally, or conditions that, in the judgment of the investigator, significantly affect gastrointestinal absorption;
  • 12. Patients who have received a live attenuated vaccine within 2 weeks before the first use of the investigational drug or plan to receive during the study;
  • 13. Other situations that the investigator considers not suitable for participating in the clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Binghe Xu, Doctor, +86-10-67781331, xubinghe@medmail.com.cn

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYH2043 in Patients With Advanced Malignant Tumors

The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SYH2043 in patients with advanced malignant tumors.

Read the detailed description

This study is an open-label, single-arm, multi-center Phase I clinical study, which includes four stages:

A: Dose-escalation Stage: The dose escalation stage is divided into 5 dose levels, and a Bayesian Optimal Interval Design (BOIN) including accelerated titration will be used for dose escalation.

B: PK Expansion Stage: Two or three dose groups will be selected for PK expansion; After PK extension the cohort extension study will be conducted as required, and will include 4 cohorts according to the tumor types.

C: Combination dose Escalation: This study will use a 3+3 design with up to 2 dose escalation cohorts at increasing levels.

D: According to the results of stage C, 1-2 combination doses will be selected for combination dose expansion, and Simon 2 stage was adopted for the expansion stage.

Being tested
SYH2043

What participants receive

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

  • SYH2043Drug

    Patients will receive SYH2043 once everyday on day 1-21 of each 28-day cycle

Study groups in NCT05728541
Study groupRoleWhat they receive
SYH2043ExperimentalPatients will receive SYH2043 once everyday on day 1-21 of each 28-day cycle
Receives: Drug: SYH2043

What is being measured

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

  1. AE

    Occurrence and frequency of Adverse Event

    Measured: Up to approximately 3 years

  2. SAE

    Serious Adverse Event

    Measured: Up to approximately 3 years

  3. DLT

    Dose-limiting Toxicity (DLT)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  4. MTD

    The maximum tolerated dose (MTD) (if available)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  5. RP2D

    Recommended phase 2 dose (RP2D) in stage A

    Measured: At the end of Stage A (approximately 1 year)

Secondary outcomes (12)

  1. AUC

    Area under the plasma concentration versus time curve (AUC)

    Measured: Up to approximately 3 years

  2. Cmax

    Peak Plasma Concentration (Cmax)

    Measured: Up to approximately 3 years

  3. t1/2

    Half-life (t1/2)

    Measured: Up to approximately 3 years

  4. Tmax

    Time to peak drug concentration (Tmax)

    Measured: Up to approximately 3 years

  5. Vz/F

    Apparent volume of distribution

    Measured: Up to approximately 3 years

  6. CL/F

    Apparent clearance

    Measured: Up to approximately 3 years

  7. pRb

    Explore the relationship between phosphor-retinoblastoma protein (pRb) and efficacy

    Measured: Up to approximately 3 years

  8. ORR

    Objective Response Rate

    Measured: Up to approximately 3 years

  9. PFS

    Progression-free Survival

    Measured: Up to approximately 3 years

  10. OS

    Overall Survival

    Measured: Up to approximately 3 years

  11. DoR

    Duration of Response (DoR)

    Measured: Up to approximately 3 years

  12. DCR

    Disease Control Rate (DCR)

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted15 Feb 2023
  2. Study start1 Mar 2023 (estimated)
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Mar 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
367 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05728541
Sponsor's protocol ID
SYH2043-001
Status last verified
Feb 2023
First submitted
27 Jan 2023
Last updated
17 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SYH2043 in people with Advanced Malignant Tumors, run by CSPC Ouyi Pharmaceutical Co., Ltd. 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 19 inclusion and 13 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 17 Feb 2023. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE (time frame: Up to approximately 3 years). The study lists 5 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 NCT05728541.

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 17 Feb 2023.

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