## Protocol Section
### Identification Module
**NCT ID:** NCT06415903

**Brief Title:** A Clinical Trial of TQB3117 Tablets in Patients With Advanced Malignant Cancer

**Official Title:** A Phase I Study to Evaluate the Safety and Tolerance of TQB3117 Tablets in Patients With Advanced Malignant Cancer

#### Organization Study ID Info
**ID:** TQB3117-I-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-14
### 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:** The study is divided into two phases: dose escalation and dose extension. The dosing regimens include a single-dose study and a multiple-dose study. It adopts a single-center, open-label, non-randomized, single-arm clinical trial design, where patients with advanced malignant cancer are selected to orally take TQB3117 tablets. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TQB3117 tablets in patients.

### Conditions Module

**Conditions:**

- Advanced Malignant Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 59

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** TQB3117 tables is administered as a single dose or multiple dose, ranging from 20 to 180 mg once daily. Oral administration on fast condition, with each cycle lasting 21 days.

**Intervention Names:**

- Drug: TQB3117 tablets

**Label:** TQB3117 tablets

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TQB3117 tablets

**Description:** TQB3117 is a protein inhibitor.

**Name:** TQB3117 tablets

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** DLT refers to occurrence of drug-related adverse events within the first treatment cycle after subjects receive single-dose or multiple-dose treatment, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria.

**Measure:** Dose Limiting Toxicity (DLT)

**Time Frame:** At the end of Cycle 1 (each cycle is 21 days)

**Description:** MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

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

**Time Frame:** At the end of Cycle 1 (each cycle is 21 days)

**Description:** DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3117 tablets in adult patients with advanced malignant cancer.

**Measure:** Recommended Phase II Dose (RP2D)

**Time Frame:** Baseline up to 24 months

#### Secondary Outcomes

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

**Measure:** Adverse events (AE)

**Time Frame:** 30 days after the last administration

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

**Measure:** Serious adverse events (SAE)

**Time Frame:** 30 days after the last administration

**Description:** To characterize the pharmacokinetics of TQB3117 by assessment of time to reach maximum plasma concentration after single and multiple dosing.

**Measure:** Time to reach maximum plasma concentration (Tmax)

**Time Frame:** Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21of cycle1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

**Description:** The maximum observed plasma concentration of study drug.

**Measure:** Peak concentration (Cmax)

**Time Frame:** Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21 of cycle 1: at 0.5,1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

**Description:** Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

**Measure:** Half-life (t1/2)

**Time Frame:** Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

**Description:** To characterize the pharmacokinetics of TQB3117 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.

**Measure:** Area under the concentration-time curve (AUC [0-infinity]

**Time Frame:** Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose, Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

**Description:** To characterize the pharmacokinetics of TQB3117 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.

**Measure:** Area under the concentration-time curve (AUC [0-t]

**Time Frame:** Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

**Description:** Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.

**Measure:** Apparent clearance (CL/F)

**Time Frame:** Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

**Description:** Apparent volume of distribution of the TQB3117 in plasma.

**Measure:** Apparent volume of distribution (Vd/F)

**Time Frame:** Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

**Description:** The percentage of complete response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.

**Measure:** Objective Response Rate (ORR)

**Time Frame:** From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
* Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria;
* The main organs function well;
* Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Exclusion Criteria:

* There were other malignant tumors in 3 years;
* Has multiple factors affecting oral medication;
* Unalleviated toxicity ≥ grade 1 above CTCAE v5.0 due to any previous therapy, excluding hair loss;
* Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
* Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
* Have a history of psychotropic drug abuse and can not quit or have mental disorders;
* Subjects with any severe and / or uncontrolled disease included: active hepatitis, have a history of immunodeficiency;
* Has known symptomatic central nervous system metastases and/or cancerous meningitis;
* Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one month after receiving the investigational drug for the first time;
* Has participated in other clinical trials within 4 weeks before first dose;
* According to the judgement of the investigators, there are other factors that may lead to the termination of 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:** sdyujinming@126.com

**Name:** Jinming Yu, Doctor

**Phone:** 13806406293

**Role:** CONTACT

**Contact 2:**

**Email:** 13370582181@163.com

**Name:** Yuping Sun, Doctor

**Phone:** 0531-67627156

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Jinan

**Contacts:**

***Contact 1:***

- **Email:** sdyujinming@126.com

- **Name:** Jinming Yu, Doctor

- **Phone:** 13806406293

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Shandong First Medical University

**State:** Shandong

**Zip:** 250117

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
