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Trial Title:
A Study of SYH2051 Monotherapy in Advanced Solid Tumors or in Combination With Radiotherapy in Locally Advanced Head and Neck Cancer
NCT ID:
NCT06011291
Condition:
Solid Tumors
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SYH2051 tablets
Description:
Arm A: Five dose levels will be administered sequentially. Arm B and C: Concurrently
administered with RT, and 2 weeks adjuvant treatment after RT.
Arm group label:
Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia)
Arm group label:
Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)
Arm group label:
Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)
Intervention type:
Radiation
Intervention name:
Intensity-Modulated Radiation Therapy (IMRT)
Description:
Radical or adjuvant radiotherapy
Arm group label:
Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)
Arm group label:
Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)
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 tumors or in combination with radiotherapy (RT) in patients with
locally advanced head and neck cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years old, male or female;
2. 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;
3. Eastern Collaborative Oncology Group (ECOG) Performance Status of 0~1;
4. Patients in medical conditions to be able to receive radiotherapy (for phase Ib/Ic);
5. Life expectancy of >3 months;
6. At least one measurable lesion (excluding patients in phase Ic combined with
adjuvant radiotherapy);
7. Patients with adequate hematologic, hepatic, renal and coagulation function;
8. Patients are not pregnant or lactating and required contraception;
9. Patients who are willing to provide written informed consent form (ICF) before the
beginning of the study.
Exclusion Criteria:
1. 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:
1. 6 weeks for Nitrosoureas or mitomycin C;
2. 2 weeks or five half-lives (whichever is longer) for oral fluorouracil and
small molecule targeted drugs;
3. 2 weeks for Chinese herbal medicine with antineoplastic indications;
2. Patients with previous (within 2 years before screening) or concurrent other
malignancies (only for phase Ib/Ic);
3. 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;
4. Severe, non-healing fractures within 4 weeks before the first dose of the study
drug;
5. 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;
6. 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;
7. Active brain metastases and/or carcinomatous meningitis;
8. Concurrent serious and/or uncontrolled medical conditions at screening (e.g., severe
chronic obstructive pulmonary disease);
9. Patients with abnormal thyroid function were not allowed, except those with
euthyroid function after drug control;
10. History of severe cardiovascular disease;
11. History of myopathy or raised creatine kinase (CK) >5 times the upper limit of
normal (ULN);
12. Known hypersensitivity or intolerance to any component of the study drug or its
excipients;
13. History of autoimmune disease, immunodeficiency disease, including HIV testing
positive or other acquired, congenital immunodeficiency diseases, or organ
transplantation;
14. Active hepatitis B virus, hepatitis C virus or active syphilis infection;
15. Active dysphagia, malabsorption or other chronic gastrointestinal diseases or
conditions that may hamper compliance and/or absorption of the study drug;
16. Other ineligibilities according to the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinical Trials Information Group
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Status:
Recruiting
Contact:
Last name:
Clinical Trials Information Group officer
Phone:
86-0311-69085587
Email:
ctr-contact@cspc.cn
Start date:
August 15, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Agency class:
Industry
Source:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011291
