Status:
UNKNOWN
A Study of SYH2051 Monotherapy in Advanced Solid Tumors or in Combination With Radiotherapy in Locally Advanced Head and Neck Cancer
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Solid Tumors
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, dose-escalation phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of SYH2051 in patients with advanced solid ...
Eligibility Criteria
Inclusion
- Age ≥18 years old, male or female;
- Phase Ia: Patients with histologically or cytologically confirmed advanced solid tumors, for whom there is no standard therapy available, or ineffective or intolerant to standard therapy. Phase Ib/Ic: Patients with histologically or cytologically confirmed locally advanced head and neck cancer suitable for radiotherapy alone;
- Eastern Collaborative Oncology Group (ECOG) Performance Status of 0\~1;
- Patients in medical conditions to be able to receive radiotherapy (for phase Ib/Ic);
- Life expectancy of \>3 months;
- At least one measurable lesion (excluding patients in phase Ic combined with adjuvant radiotherapy);
- Patients with adequate hematologic, hepatic, renal and coagulation function;
- Patients are not pregnant or lactating and required contraception;
- Patients who are willing to provide written informed consent form (ICF) before the beginning of the study.
Exclusion
- Any antineoplastic therapy such as chemotherapy, biologic therapy, endocrine therapy, or immunotherapy within 4 weeks before the first dose of the study drug (or within 5 half-lives of other unmarketed study drugs, whichever is longer), except for the following:
- 6 weeks for Nitrosoureas or mitomycin C;
- 2 weeks or five half-lives (whichever is longer) for oral fluorouracil and small molecule targeted drugs;
- 2 weeks for Chinese herbal medicine with antineoplastic indications;
- Patients with previous (within 2 years before screening) or concurrent other malignancies (only for phase Ib/Ic);
- Patients had undergone major organ surgery (excluding needle biopsies) within 4 weeks before the first dose, with obvious trauma, or require elective surgery during the study;
- Severe, non-healing fractures within 4 weeks before the first dose of the study drug;
- The adverse reactions of previous antineoplastic therapy have not recovered to ≤grade 1 as determined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria;
- Patients who had received treatment with any drug that is a medium or strong inhibitor or inducer of cytochrome P450 (CYP) 3A4/5 enzyme activity within 2 weeks before screening or need to continue receiving such drugs;
- Active brain metastases and/or carcinomatous meningitis;
- Concurrent serious and/or uncontrolled medical conditions at screening (e.g., severe chronic obstructive pulmonary disease);
- Patients with abnormal thyroid function were not allowed, except those with euthyroid function after drug control;
- History of severe cardiovascular disease;
- History of myopathy or raised creatine kinase (CK) \>5 times the upper limit of normal (ULN);
- Known hypersensitivity or intolerance to any component of the study drug or its excipients;
- History of autoimmune disease, immunodeficiency disease, including HIV testing positive or other acquired, congenital immunodeficiency diseases, or organ transplantation;
- Active hepatitis B virus, hepatitis C virus or active syphilis infection;
- Active dysphagia, malabsorption or other chronic gastrointestinal diseases or conditions that may hamper compliance and/or absorption of the study drug;
- Other ineligibilities according to the investigator.
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06011291
Start Date
August 15 2023
End Date
August 31 2025
Last Update
October 27 2023
Active Locations (1)
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1
Clinical Trials Information Group
Shijiazhuang, Hebei, China, 050000