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The trial comprises Phase I dose escalation/expansion and Phase II combination therapy. Using a multicenter, open-label, non-randomized design, breast cancer patients will receive TQB3126 to assess its safety, tolerability, pharmacokinetics and preliminary efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3126 | Experimental | Administered in accordance with the protocol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3126 | Drug | TQB3126 is a targeted protein degrader. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT is defined as toxicities that meet pre-defined severity criteria (according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0) and are assessed as related to TQB3126, occurring from the first dose to the end of the first treatment cycle. | From first dose of TQB3126 to the end of Cycle 1, approximately 35 days. |
| Maximum Tolerated Dose (MTD) | MTD is defined as the highest dose at which DLT occurs in less than 33% of subjects. | From first dose of TQB3126 to the end of Cycle 1, approximately 35 days. |
| Recommended Phase II Dose (RP2D) | The dose recommended for Phase II study based on integrated safety, tolerability, pharmacokinetic and efficacy data. | Observation is expected to continue through Cycle 6 Day 28 throughout the study, around 6 months. |
| Adverse Events (AEs) | The occurrence, incidence and severity of all adverse events (AEs). | From the time of first dose of TQB3126 to 28 days after the last dose or until the start of other anti-tumor therapy, whichever occurs first. |
| Serious Adverse Events (SAEs) | The occurrence, incidence and severity of all serious adverse events (SAEs). | From the time of first dose of TQB3126 to 28 days after the last dose or until the start of other anti-tumor therapy, whichever occurs first. |
| Abnormal Incidence of Laboratory Test Indicators | Incidence and severity of abnormal laboratory values. | From the time of first dose of TQB3126 to 28 days after the last dose or until the start of other anti-tumor therapy, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Concentration (Cmax) | Maximum observed plasma concentration of TQB3126. | Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Herui Yao, Doctor | Contact | +86 13500018020 | yaohrsysu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510288 | China |
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| Objective Response Rate (ORR) | The proportion of subjects with a best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1. | From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years. |
| Time to Reach Maximum Plasma Concentration (Tmax) |
Time to reach the maximum plasma concentration of TQB3126. |
| Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1. |
| Elimination Half-life (t1/2) | Elimination half-life of TQB3126 after oral dosing. | Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1. |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) | Area under the plasma concentration-time curve from time zero to the last measurable concentration. | Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1. |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) | Area under the plasma concentration-time curve from time zero extrapolated to infinity. | Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1. |
| Apparent Clearance (CL/F) | Apparent total clearance of TQB3126 from plasma. | Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1. |
| Apparent Volume of Distribution (Vz/F) | Apparent volume of distribution of TQB3126 in plasma. | Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1. |
| Clinical Benefit Rate (CBR) | The proportion of subjects with a best overall response of complete response, partial response, or stable disease lasting a pre-specified minimum duration, per RECIST v1.1. | From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years. |
| Disease Control Rate (DCR) | The proportion of subjects with a best overall response of complete response, partial response, or stable disease, per RECIST v1.1. | From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years. |
| Duration of Response (DOR) | The time from the first documentation of complete or partial response to the first documentation of disease progression. | From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years. |
| Progression-Free Survival (PFS) | The time from the first dose to the first documentation of disease progression or death from any cause, whichever occurs first. | From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years. |
| Time to Response (TTR) | The time from the first dose to the first documentation of complete or partial response. | From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years. |
| Meizhou People's Hospital | Meizhou | Guangdong | 514000 | China |
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| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430000 | China |
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| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China |
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| Sichuan Cancer Hospital | Chengdu | Sichuan | 610041 | China |
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| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300202 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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