- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06011291
A Study of SYH2051 Monotherapy in Advanced Solid Tumors or in Combination With Radiotherapy in Locally Advanced Head and Neck Cancer
October 26, 2023 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYH2051 Monotherapy in Patients With Advanced Solid Tumors or in Combination With Radiotherapy in Patients With Locally Advanced Head and Neck Cancer
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
73
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Information Group officer
- Phone Number: 86-0311-69085587
- Email: ctr-contact@cspc.cn
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050000
- Recruiting
- Clinical Trials Information Group
-
Contact:
- Clinical Trials Information Group officer
- Phone Number: 86-0311-69085587
- Email: ctr-contact@cspc.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia)
|
Arm A: Five dose levels will be administered sequentially.
Arm B and C: Concurrently administered with RT, and 2 weeks adjuvant treatment after RT.
|
Experimental: Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)
|
Arm A: Five dose levels will be administered sequentially.
Arm B and C: Concurrently administered with RT, and 2 weeks adjuvant treatment after RT.
Radical or adjuvant radiotherapy
|
Experimental: Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)
|
Arm A: Five dose levels will be administered sequentially.
Arm B and C: Concurrently administered with RT, and 2 weeks adjuvant treatment after RT.
Radical or adjuvant radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of dose-limiting toxicities (DLTs)
Time Frame: 31 days for Arm A and 11 weeks for Arm B
|
31 days for Arm A and 11 weeks for Arm B
|
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 2 years
|
2 years
|
Maximum tolerated dose (MTD)(if any) or maximum administrated dose (MAD)
Time Frame: up to 1 year
|
up to 1 year
|
Recommended phase 2 dose (RP2D) of SYH2051 in combination with RT
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (ORR)
Time Frame: 2 years
|
2 years
|
Phase Ia: Maximum Plasma Concentration (Cmax)
Time Frame: 1 years
|
1 years
|
Phase Ia: Time to Maximum Plasma Concentration (Tmax)
Time Frame: 1 years
|
1 years
|
Phase Ia: Area under the plasma concentration-time curve from time zero to time of last measurable concentration(AUC0-last)
Time Frame: 1 years
|
1 years
|
Phase Ia: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time Frame: 1 years
|
1 years
|
Disease Control Rate (DCR)
Time Frame: 2 years
|
2 years
|
Duration of locoregional control (DoLC)
Time Frame: 2 years
|
2 years
|
Phase Ib and Ic: Concentrations of SYH2051
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2023
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
August 31, 2025
Study Registration Dates
First Submitted
August 14, 2023
First Submitted That Met QC Criteria
August 21, 2023
First Posted (Actual)
August 25, 2023
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYH2051-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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