Clinical Trials/NCT06011291

NCT06011291

Recruiting

Phase 1

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

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country73 target enrollmentAugust 15, 2023

ConditionsSolid Tumors Head and Neck Cancer

InterventionsSYH2051 tablets Intensity-Modulated Radiation Therapy (IMRT)

DrugsSYH2051 tablets

Overview

Phase: Phase 1
Intervention: SYH2051 tablets
Conditions: Solid Tumors
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 73
Locations: 1
Primary Endpoint: Incidence of dose-limiting toxicities (DLTs)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 tumors or in combination with radiotherapy (RT) in patients with locally advanced head and neck cancer.

Registry

clinicaltrials.gov

Start Date

August 15, 2023

End Date

August 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia)

Intervention: SYH2051 tablets

Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)

Intervention: SYH2051 tablets

Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)

Intervention: Intensity-Modulated Radiation Therapy (IMRT)

Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)

Intervention: SYH2051 tablets

Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)

Intervention: Intensity-Modulated Radiation Therapy (IMRT)

Outcomes

Primary Outcomes

Incidence of dose-limiting toxicities (DLTs)

Time Frame: 31 days for Arm A and 11 weeks for Arm B

Recommended phase 2 dose (RP2D) of SYH2051 in combination with RT

Time Frame: 2 years

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

Secondary Outcomes

Phase Ia: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)(1 years)
Disease Control Rate (DCR)(2 years)
Phase Ia: Maximum Plasma Concentration (Cmax)(1 years)
Phase Ia: Time to Maximum Plasma Concentration (Tmax)(1 years)
Objective response rate (ORR)(2 years)
Phase Ia: Area under the plasma concentration-time curve from time zero to time of last measurable concentration(AUC0-last)(1 years)
Duration of locoregional control (DoLC)(2 years)
Phase Ib and Ic: Concentrations of SYH2051(2 years)