Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of SYHA1801 Monotherapy in Patients With Advanced Solid Tumors

NCT04309968 | Unknown Phase 1

• 1 other identifier: SYHA1801201901/PRO
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of SYHA1801, a BRD4 inhibitor in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• To evaluate AE,SAE and DLT of SYHA1801.

  The occurrence and frequency of AE, SAE and DLT. To evaluate the safety and tolerability of SYHA1801.

  28 days

• To evaluate the MTD of SYHA1801

  The maximum tolerable dose (MTD) (if it has), recommended phase II dose (RP2D) and dosage regimen of SYHA1801.

  through study completion, an average of 1 year

Secondary Outcomes (10)

• AUC0-last of SYHA1801.

  31 days

• AUC0-∞ of SYHA1801.

  31 days

• Cmax of SYHA1801.

  31 days

• Tmax of SYHA1801.

  31 days

• t½ of SYHA1801.

  31 days

Other Outcomes (1)

• Biomarkers and Beneficiaries

  2 months

Study Arms (2)

solid tumors

EXPERIMENTAL

Experimental: Solid tumors Part 1 - Dose-escalation of SYHA1801 in patients with advanced solid tumors.Daily dosing of SYHA1801 on Days 1 and 4-31 of 28-day cycle. Escalating dose cohorts.

Drug: Drug: SYHA1801

advanced cancers

EXPERIMENTAL

Part 2 - Dose-expansion of SYHA1801 in patients with advanced cancers potentially sensitive to BRD4 inhibitor.The dose level and schedule of SYHA1801 of 28-day cycle at the MTD determined in Part 1.

Drug: Drug: SYHA1801

Interventions

Drug: SYHA1801 DRUG

Drug: SYHA1801 administered orally

advanced cancers; solid tumors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18, ≤75 years, no gender limitation.
• Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven ineffective, intolerable or inacceptable for the patient.
• At least one measurable lesion as per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1.
• Life expectancy ≥3 months.
• Adequate bone marrow reserve, renal and liver function.
• Women of childbearing potential should agree to use contraceptive measures (such as IUD, contraceptive or condom) during the study and within 6 months after the end of the study; the serum pregnancy test should be negative within 7 days before enrollment, and must be non-lactating subjects; men should agree to use contraceptive measures during the study and within 6 months after the end of the study.
• Signed informed consent form.

You may not qualify if:

• Administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first dose of the study drug, except the following: using nitrosourea and mitomycin C within 6 weeks, using fluorouracil and small molecule targeted drugs within 2 weeks (or within 5 half time period), using traditional Chinese medicine with anti-tumor indications within 2 weeks.
• Administration of other unlisted clinical research drugs within 4 weeks before the first dose of SYHA1801.
• Major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of SYHA1801.
• Administration of glucocorticoids or other immunosuppressants within 14 days prior to the first dose of SYHA1801, except the following: local, ocular, intraarticular, intranasal and inhaled glucocorticoids; short-term use of glucocorticoids for preventive treatment.
• Concomitant therapy with strong CYP3A4 inhibitors or inducers within 14 days.
• Prior treatment with BET inhibitors.
• Persistent grade \>1 clinically significant toxicity related to prior antineoplastic therapies (except alopecia).
• Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, that is not suitable for the group according to the judgment of the investigator.
• Uncontrollable active infection.
• History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history.
• Active hepatitis B; positive for hepatitis C antibody.
• History of serious cardiovascular disease.
• Inability to swallow oral medications or presence of a gastrointestinal disorder deemed to jeopardize intestinal absorption of SYHA1801.
• Other serious illness or medical conditions.
• Alcohol or drug dependence.

Sponsors & Collaborators

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

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 022, China

RECRUITING

Study Design

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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 17, 2020
• Study Start: April 7, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: June 9, 2020

Record last verified: 2020-03

Locations

CN (1)