A Study of SYH2051 Monotherapy in Advanced Solid Tumors or in Combination With Radiotherapy in Locally Advanced Head and Neck Cancer

NCT06011291 | Unknown Phase 1

• 1 other identifier: SYH2051-001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors; Head and Neck Cancer

Outcome Measures

Primary Outcomes (4)

• Incidence of dose-limiting toxicities (DLTs)

  31 days for Arm A and 11 weeks for Arm B

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  2 years

• Maximum tolerated dose (MTD)(if any) or maximum administrated dose (MAD)

  up to 1 year

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

  2 years

Secondary Outcomes (8)

• Phase Ia: Maximum Plasma Concentration (Cmax)

  1 years

• Phase Ia: Time to Maximum Plasma Concentration (Tmax)

  1 years

• Phase Ia: Area under the plasma concentration-time curve from time zero to time of last measurable concentration(AUC0-last)

  1 years

• Phase Ia: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)

  1 years

• Objective response rate (ORR)

  2 years

Study Arms (3)

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)

Interventions

SYH2051 tablets DRUG

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 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) RADIATION

Radical or adjuvant radiotherapy

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• weeks for Nitrosoureas or mitomycin C;
• weeks or five half-lives (whichever is longer) for oral fluorouracil and small molecule targeted drugs;
• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Clinical Trials Information Group

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 25, 2023
• Study Start: August 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: August 31, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

CN (1)