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

NCT05728541 | Not Yet Recruiting Phase 1

• 1 other identifier: SYH2043-001
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (5)

• AE

  Occurrence and frequency of Adverse Event

  Up to approximately 3 years

• SAE

  Serious Adverse Event

  Up to approximately 3 years

• DLT

  Dose-limiting Toxicity (DLT)

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

• MTD

  The maximum tolerated dose (MTD) (if available)

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

• RP2D

  Recommended phase 2 dose (RP2D) in stage A

  At the end of Stage A (approximately 1 year)

Secondary Outcomes (12)

• AUC

  Up to approximately 3 years

• Cmax

  Up to approximately 3 years

• t1/2

  Up to approximately 3 years

• Tmax

  Up to approximately 3 years

• Vz/F

  Up to approximately 3 years

Study Arms (1)

SYH2043

EXPERIMENTAL

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

Drug: SYH2043

Interventions

SYH2043 DRUG

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

SYH2043

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients aged 18-75 years (inclusive);
• \. Histological or cytological confirmation of advanced malignant tumors;
• \. 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-;
• \. With at least one measurable lesion according to RECIST v1.1;
• \. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
• \. Life expectancy greater than 3 months;
• \. 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;

You may not qualify if:

• \. 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;
• \. Have received other unmarketed clinical investigational drugs or treatments within 4 weeks before the first dose of the investigational drug;
• \. 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;
• \. 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;
• \. Have received potent inhibitors or inducers of CYP3A4 and inhibitors of P-gp within 1 weeks before the first dose of the investigational drug;
• \. 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;
• \. Breast cancer patients with visceral crisis or symptomatic visceral metastasis;
• \. With active central nervous system (CNS) metastasis and/or cancerous meningitis;
• \. 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;
• \. Participants with a history of severe cardiovascular disease;
• \. Inability to swallow medications orally, or conditions that, in the judgment of the investigator, significantly affect gastrointestinal absorption;
• \. 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;
• \. Other situations that the investigator considers not suitable for participating in the clinical study.

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 15, 2023
• Study Start: March 1, 2023
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

CN (1)