A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets

NCT04408079 | Unknown Phase 1

• 1 other identifier: TQB3558-Ⅰ-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD)

  MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.

  Baseline up to 28 days

• Adverse events (AE) and serious adverse events (SAE)

  The occurrence of all adverse events (AE) and serious adverse events (SAE).

  Baseline up to 28 days

• Overall response rate (ORR)

  Percentage of participants achieving complete response (CR) and partial response (PR).

  up to 96 weeks

Secondary Outcomes (7)

• Tmax

  15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.

• Cmax

  15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.

• AUC0-t

  15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.

• CL/f

  15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.

• Disease control rate（DCR）

  up to 96 weeks

Study Arms (1)

TQB3558 Tablets

EXPERIMENTAL

TQB3558 tablets administered orally once. Then TQB3558 tablet administered orally, once daily in 28-day cycle after 4 days of first administration.

Drug: TQB3558

Interventions

TQB3558 DRUG

TQB3558 is a kinase inhibitor of the TRK protein family.

TQB3558 Tablets

Eligibility Criteria

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

You may qualify if:

• \. Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
• \. Has at least one measurable lesion (based on RECIST 1.1) or bone metastases. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. 6. Understood and signed an informed consent form.

You may not qualify if:

• \. Has received TRK inhibitors. 2. Has participated in any other clinical trials, or used other anti-cancer drugs, or received major surgical operations within 4 weeks before first administration.
• \. Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.
• \. Has other malignant tumors in 2 years, except for cured or locally curable cancers.
• \. Has known spinal cord compression and cancerous meningitis. 6. Has interstitial lung disease, drug-induced interstitial lung disease, history of radiation lung disease requiring steroid therapy.
• \. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
• \. Obvious cardiovascular diseases. 9. Has a history of autoimmune disease, immunodeficiency. 10. Lactating women. 11. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Central Study Contacts

Zan Shen, Doctor

CONTACT

021-24058431; Sshenzzan@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: June 25, 2020
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2022
• Last Updated: July 8, 2020

Record last verified: 2020-06

Locations

CN (1)