## Protocol Section
### Identification Module
**NCT ID:** NCT06413953

**Brief Title:** A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

**Official Title:** A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors

#### Organization Study ID Info
**ID:** TQB3107-I-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

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

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-10
### 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:** TQB3107 is a protein inhibitor that induces apoptosis and inhibits the proliferation of various tumor cells. This clinical study aims to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D).

### Conditions Module

**Conditions:**

- Advanced Cancers

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 140

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Dosing regimen 1 (20/28): 28 days per cycle (4 weeks), the medication is administered once daily for 5 consecutive days per week, followed by a 2-day break. The initial dose is a single fasting dose of C0, with a subsequent 7-day observation period.

Dosing regimen 2 (28/28): 28 days per cycle, the medication is administered once daily for the entire 28-day period, all other dosing requirements are consistent with Regimen 1.

**Intervention Names:**

- Drug: TQB3107 Tablets

**Label:** TQB3107 tablets

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TQB3107 tablets

**Description:** TQB3107 tablets is protein inhibitor that inhibit tumor cell proliferation, and induce apoptosis, thereby exerting anti-tumor effects.

**Name:** TQB3107 Tablets

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** DLT refers to toxicities that are associated with the drug and occur from the first medication administration to the end of the first treatment cycle, 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 28 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 28 days)

**Description:** The recommended dose, determined after initial dose escalation and toxicity assessment, it is used to further evaluate the efficacy and safety of the drug.

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

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

#### Secondary Outcomes

**Description:** The time it takes for the concentration of the drug in the plasma to be reduced by 50%.

**Measure:** Elimination half-life (t1/2)

**Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose

**Description:** The time it takes to reach peak concentrations after administration.

**Measure:** Time to Peak (Tmax)

**Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose；Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose

**Description:** Maximum plasma concentration of drug.

**Measure:** Peak Concentration (Cmax)

**Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose

**Description:** The area enclosed by the plasma concentration curve against the timeline.

**Measure:** Area under the plasma concentration-time curve (AUC0-last)

**Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose

**Description:** The highest plasma drug concentration that occurs after stabilization.

**Measure:** Steady-state peak concentration (Css-max)

**Time Frame:** Day 1 of cycle 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose

**Description:** Minimum plasma drug concentration during dosing.

**Measure:** Steady-state trough concentration (Css-min)

**Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-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:** Up to 2 years

**Description:** Proportion of patients whose tumors achieve remission (PR+CR) and stable disease (SD) after treatment and can maintain the minimum timeframe required according to accepted response evaluation criteria (e.g., RECIST version 1.1 for solid tumors).

**Measure:** Disease Control Rate (DCR)

**Time Frame:** Up to 2 years

**Description:** The time from first documented response to documented disease progression.

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

**Time Frame:** Up to 2 years

**Description:** The time from the start of treatment to tumor progression or death from any cause, whichever occurs first.

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

**Time Frame:** Up to 2 years

**Description:** The time from the start of treatment to death from any cause.

**Measure:** Overall Survival (OS)

**Time Frame:** Up to 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18 years ≤ age≤ 75 years (calculated from the date of signing the informed consent); Score 0\~1 point, estimated survival ≥ 3 months；
* Malignant tumors with no standard treatment regimen or disease progression or intolerance after prior standard therapy；
* The major organs are functioning well；
* Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception throughout the study and for 6 months after the study ends;
* Subjects voluntarily participated in this study, signing the informed consent form and demonstrating good compliance.

Exclusion Criteria:

* Hematologic malignancy has or is suspected to involve the central nervous system, or primary central nervous system lymphoma;
* Received any anti-cancer therapy such as major surgery, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to the first dose;
* Combined with severe or not well-controlled diseases, which the investigator judges to be at greater risk of entering this study；
* Those with a history of drug addiction or substance abuse；
* Based on the investigator's judgement, subjects with concomitant diseases that pose a significant risk to their safety or compromise the study's completion, or subjects deemed unsuitable for enrollment due to other reasons, will be excluded.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lzmsysu@163.com

**Name:** ZhiMing Li, Doctor

**Phone:** 13719189172

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** lzmsysu@163.com

- **Name:** ZhiMing Li, Doctor

- **Phone:** 13719189172

- **Role:** CONTACT

**Country:** China

**Facility:** Sun Yat-sen University Cancer Cen

**State:** Guangdong

**Zip:** 510060

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
