Clinical Trial of TQB3126 for Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Breast Cancer Subjects

NCT07697443 | Not Yet Recruiting Phase 1

• 1 other identifier: TQB3126-I/II-01
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

Secondary Outcomes (12)

• Peak Concentration (Cmax)

  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.

• Time to Reach Maximum Plasma Concentration (Tmax)

  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)

  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)

  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-∞)

  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.

Study Arms (1)

TQB3126

EXPERIMENTAL

Administered in accordance with the protocol

Drug: TQB3126

Interventions

TQB3126 DRUG

TQB3126 is a targeted protein degrader.

TQB3126

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good treatment compliance.
• Aged 18 to 75 years at the time of informed consent signature; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; estimated survival expectancy of more than 3 months.
• Histopathologically confirmed breast cancer.
• Documented disease progression confirmed by clinical or imaging evidence during or after the most recent prior systemic therapy prior to the first study drug administration.
• Have evaluable lesions per RECIST v1.1 criteria (measurable lesions; or bone-only metastases with at least one osteolytic or mixed lesion).
• Adequate tissue samples shall be provided at screening for gene mutation testing to clarify genetic status.
• Laboratory test results meet the criteria specified in the protocol (blood routine, liver and renal function, coagulation function, cardiac ultrasound Left Ventricular Ejection Fraction(LVEF) and other indicators are all within the protocol-specified ranges).
• Subjects of childbearing potential must agree to use effective contraceptive measures throughout the study and for 6 months after study completion (the same requirement applies to male subjects); serum or urine pregnancy test result is negative within 7 days prior to enrollment.

You may not qualify if:

• Other malignant tumors within 5 years prior to first dose, except those cured by single surgical treatment with at least 5 years of disease-free survival, or cured differentiated thyroid cancer, cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors.
• Conditions affecting intravenous access or blood sampling, or multiple factors affecting oral drug administration/absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction).
• Unresolved toxicity from prior therapy of Grade \>1 (CTCAE v6.0), except Grade 2 alopecia, Grade 2 anemia, clinically insignificant laboratory abnormalities, or hypothyroidism stable on hormone replacement therapy.
• Major surgery, significant traumatic injury within 4 weeks before first dose, anticipated need for major surgery during the study, or long-standing unhealed fracture.
• Any bleeding event of Grade \>=3 within 4 weeks before first dose.
• Arterial/venous thrombotic events within 6 months before first dose (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism), excluding catheter-related or superficial venous thrombosis.
• Active viral hepatitis that is poorly controlled (Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)-infected subjects meeting protocol-specified criteria may be enrolled).
• Active syphilis infection requiring treatment.
• Active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or radiation pneumonitis requiring treatment, or history of/current interstitial lung disease (ILD).
• History of psychotropic substance abuse unable to be discontinued, mental disorders, epilepsy requiring treatment, or severe psychiatric/neurological disease.
• Planned or prior allogeneic bone marrow or solid organ transplantation.
• Decompensated cirrhosis (Child-Pugh Class B or C) or history of hepatic encephalopathy.
• Significant cardiovascular disease, including New York Heart Association(NYHA) Class \>II heart failure, clinically significant ventricular arrhythmia, unstable angina, myocardial infarction within 12 months, markedly prolonged QT interval corrected by Fridericia's formula (QTcF), or personal/family history of congenital long QT syndrome.
• Poorly controlled hypertension (resting systolic BP \>=160 mmHg or diastolic BP \>=100 mmHg on at least 2 measurements \>=24 hours apart).
• Active or uncontrolled serious infection (Grade \>=2).

Sponsors & Collaborators

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

Study Sites (6)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510288, China

Location

Meizhou People's Hospital

Meizhou, Guangdong, 514000, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300202, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Herui Yao, Doctor

CONTACT

+86 13500018020; yaohrsysu@163.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: July 7, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 13, 2026

Record last verified: 2026-04

Locations

CN (6)