## Protocol Section
### Identification Module
**NCT ID:** NCT04408079

**Brief Title:** A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets

**Official Title:** A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets

#### Organization Study ID Info
**ID:** TQB3558-Ⅰ-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2022-10-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-07-08

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-06

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-06-25

**Type:** ACTUAL

**Status Verified Date:** 2020-06

#### Study First Post Date
**Date:** 2020-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-26
**Study First Submit QC Date:** 2020-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Advanced Solid Tumors

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: TQB3558

**Label:** TQB3558 Tablets

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TQB3558 Tablets

**Description:** TQB3558 is a kinase inhibitor of the TRK protein family.

**Name:** TQB3558

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Maximum tolerated dose (MTD)

**Time Frame:** Baseline up to 28 days

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

**Measure:** Adverse events (AE) and serious adverse events (SAE)

**Time Frame:** Baseline up to 28 days

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

**Measure:** Overall response rate (ORR)

**Time Frame:** up to 96 weeks

#### Secondary Outcomes

**Description:** To characterize the pharmacokinetics of TQB3558 by assessment of time to reach maximum plasma concentration.

**Measure:** Tmax

**Time Frame:** 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.

**Description:** Cmax is the maximum plasma concentration of TQB3558 or metabolite(s).

**Measure:** Cmax

**Time Frame:** 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.

**Description:** To characterize the pharmacokinetics of TQB3558 by assessment of area under the plasma concentration time curve from zero to infinity.

**Measure:** AUC0-t

**Time Frame:** 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.

**Description:** CL/f is total clearance rate for TQB3558.

**Measure:** CL/f

**Time Frame:** 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.

**Description:** Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).

**Measure:** Disease control rate（DCR）

**Time Frame:** up to 96 weeks

**Description:** PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.

**Measure:** Progression-free survival (PFS)

**Time Frame:** up to 96 weeks

**Description:** DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

**Measure:** Duration of Response (DOR)

**Time Frame:** up to 96 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1. Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.

  2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.

  3. 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.

Exclusion Criteria:

* 1. 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.

  3. Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.

  4. Has other malignant tumors in 2 years, except for cured or locally curable cancers.

  5. 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.

  7. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.

  8. 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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Sshenzzan@vip.sina.com

**Name:** Zan Shen, Doctor

**Phone:** 021-24058431

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** Sshenzzan@vip.sina.com

- **Name:** Zan Shen, Doctor

- **Phone:** 021-24058431

- **Role:** CONTACT

***Contact 2:***

- **Name:** Zan Shen, Doctor

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Shanghai Sixth People's Hospital

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200233

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
