Solid TumorsPhase 1NCT06011291
A Study of SYH2051 Monotherapy in Advanced Solid Tumors or in Combination With Radiotherapy in Locally Advanced Head and Neck Cancer
A Phase 1 study testing SYH2051 tablets and Intensity-Modulated Radiation Therapy (IMRT) in people with Solid Tumors and Head and Neck Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Head and Neck Cancer
- What is being tested?
- SYH2051 tablets and Intensity-Modulated Radiation Therapy (IMRT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2023to 31 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Clinical Trials Information Group
Shijiazhuang, Hebei, 050000
Clinical Trials Information Group officer, 86-0311-69085587, ctr-contact@cspc.cn
About this study
Official title: 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.
- Conditions
- Solid Tumors, Head and Neck Cancer
- Being tested
- SYH2051 tablets, Intensity-Modulated Radiation Therapy (IMRT)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2051 tabletsDrug
Arm A: Five dose levels will be administered sequentially. Arm B and C: Concurrently administered with RT, and 2 weeks adjuvant treatment after RT.
Intensity-Modulated Radiation Therapy (IMRT)Radiation
Radical or adjuvant radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia) | Experimental | Not described Receives: Drug: SYH2051 tablets |
| Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib) | Experimental | Not described Receives: Drug: SYH2051 tablets; Radiation: Intensity-Modulated Radiation Therapy (IMRT) |
| Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic) | Experimental | Not described Receives: Drug: SYH2051 tablets; Radiation: Intensity-Modulated Radiation Therapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Measured: 31 days for Arm A and 11 weeks for Arm B
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: 2 years
Maximum tolerated dose (MTD)(if any) or maximum administrated dose (MAD)
Measured: up to 1 year
Recommended phase 2 dose (RP2D) of SYH2051 in combination with RT
Measured: 2 years
Secondary outcomes (8)
Phase Ia: Maximum Plasma Concentration (Cmax)
Measured: 1 years
Phase Ia: Time to Maximum Plasma Concentration (Tmax)
Measured: 1 years
Phase Ia: Area under the plasma concentration-time curve from time zero to time of last measurable concentration(AUC0-last)
Measured: 1 years
Phase Ia: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Measured: 1 years
Objective response rate (ORR)
Measured: 2 years
Disease Control Rate (DCR)
Measured: 2 years
Duration of locoregional control (DoLC)
Measured: 2 years
Phase Ib and Ic: Concentrations of SYH2051
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start15 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011291
- Sponsor's protocol ID
- SYH2051-001
- Status last verified
- Oct 2023
- First submitted
- 14 Aug 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06011291
- Acronym / sponsor ID
- SYH2051-001
- Conditions
- Solid Tumors, Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia) | Experimental | Drug: SYH2051 tablets |
| Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib) | Experimental | Drug: SYH2051 tablets, Radiation: Intensity-Modulated Radiation Therapy (IMRT) |
| Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic) | Experimental | Drug: SYH2051 tablets, Radiation: Intensity-Modulated Radiation Therapy (IMRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (19 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYH2051 tabletsArm A: Five dose levels will be administered sequentially. Arm B and C: Concurrently administered with RT, and 2 weeks adjuvant treatment after RT. | Drug | Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia), Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib), Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic) |
| Intensity-Modulated Radiation Therapy (IMRT)Radical or adjuvant radiotherapy | Radiation | Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib), Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic) |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: 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
Maximum tolerated dose (MTD)(if any) or maximum administrated dose (MAD)
Time frame: up to 1 year
Recommended phase 2 dose (RP2D) of SYH2051 in combination with RT
Time frame: 2 years
8 secondary outcomes
Phase Ia: Maximum Plasma Concentration (Cmax)
Time frame: 1 years
Phase Ia: Time to Maximum Plasma Concentration (Tmax)
Time frame: 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
Phase Ia: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: 1 years
Objective response rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of locoregional control (DoLC)
Time frame: 2 years
Phase Ib and Ic: Concentrations of SYH2051
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYH2051 tablets and Intensity-Modulated Radiation Therapy (IMRT) in people with Solid Tumors and Head and Neck Cancer, run by CSPC ZhongQi Pharmaceutical Technology 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 9 inclusion and 19 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 27 Oct 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?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) (time frame: 31 days for Arm A and 11 weeks for Arm B). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2023.