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

7. juli 2026 opdateret af: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3126 in Subjects With Breast Cancer

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

306

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510288
        • Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
        • Kontakt:
      • Meizhou, Guangdong, Kina, 514000
        • Meizhou People's Hospital
        • Kontakt:
    • Hubei
      • Wuhan, Hubei, Kina, 430000
        • Zhongnan Hospital of Wuhan University
        • Kontakt:
    • Hunan
      • Changsha, Hunan, Kina, 410000
        • The Third Xiangya Hospital of Central South University
        • Kontakt:
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Sichuan Cancer Hospital
        • Kontakt:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300202
        • Tianjin Medical University Cancer Institute & Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good treatment compliance.
  2. 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.
  3. Histopathologically confirmed breast cancer.
  4. 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.
  5. Have evaluable lesions per RECIST v1.1 criteria (measurable lesions; or bone-only metastases with at least one osteolytic or mixed lesion).
  6. Adequate tissue samples shall be provided at screening for gene mutation testing to clarify genetic status.
  7. 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).
  8. 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.

Exclusion Criteria:

  1. 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.
  2. Conditions affecting intravenous access or blood sampling, or multiple factors affecting oral drug administration/absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction).
  3. 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.
  4. Major surgery, significant traumatic injury within 4 weeks before first dose, anticipated need for major surgery during the study, or long-standing unhealed fracture.
  5. Any bleeding event of Grade >=3 within 4 weeks before first dose.
  6. 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.
  7. Active viral hepatitis that is poorly controlled (Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)-infected subjects meeting protocol-specified criteria may be enrolled).
  8. Active syphilis infection requiring treatment.
  9. Active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or radiation pneumonitis requiring treatment, or history of/current interstitial lung disease (ILD).
  10. History of psychotropic substance abuse unable to be discontinued, mental disorders, epilepsy requiring treatment, or severe psychiatric/neurological disease.
  11. Planned or prior allogeneic bone marrow or solid organ transplantation.
  12. Decompensated cirrhosis (Child-Pugh Class B or C) or history of hepatic encephalopathy.
  13. 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.
  14. Poorly controlled hypertension (resting systolic BP >=160 mmHg or diastolic BP >=100 mmHg on at least 2 measurements >=24 hours apart).
  15. Active or uncontrolled serious infection (Grade >=2).
  16. Renal failure requiring hemodialysis or peritoneal dialysis; or history of/current nephrotic syndrome (except cured) or chronic nephritis.
  17. History of immunodeficiency, including HIV infection or other acquired/congenital immunodeficiency diseases.
  18. Poorly controlled autoimmune disease requiring immunosuppressants or systemic corticosteroids for immunosuppression, continued within 7 days before first dose (except low-dose corticosteroids).
  19. Clinically significant endometrial abnormalities (including hyperplasia, dysfunctional uterine bleeding, etc.).
  20. Tumor-related conditions/treatments: anti-cancer therapy within 3 weeks before first dose or still within the drug's washout period; prior local radiotherapy not meeting protocol-specified interval or target lesion requirements; use of National Medical Products Administration (NMPA)-approved proprietary Chinese medicine with anti-tumor indications within 1 week before first dose; imaging showing tumor invasion of major vessels with risk of fatal hemorrhage; uncontrolled pleural effusion/ascites/moderate-or-greater pericardial effusion requiring repeated drainage; known leptomeningeal metastasis or uncontrolled brain metastasis symptoms; severe skeletal-related events due to bone metastases.
  21. Known hypersensitivity to the study drug or its excipients.
  22. Participation in and use of another investigational anti-tumor drug within 4 weeks before first dose.
  23. Any concomitant disease or condition that, in the investigator's judgment, seriously endangers subject safety or study compliance, or any other reason making the subject unsuitable for enrollment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TQB3126
Administered in accordance with the protocol
Medicin: TQB3126
TQB3126 is a targeted protein degrader.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose Limiting Toxicity (DLT)
Tidsramme: From first dose of TQB3126 to the end of Cycle 1, approximately 35 days.
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)
Tidsramme: From first dose of TQB3126 to the end of Cycle 1, approximately 35 days.
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)
Tidsramme: Observation is expected to continue through Cycle 6 Day 28 throughout the study, around 6 months.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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
Tidsramme: 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.
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)
Tidsramme: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak Concentration (Cmax)
Tidsramme: 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.
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.
Time to Reach Maximum Plasma Concentration (Tmax)
Tidsramme: 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 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)
Tidsramme: 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 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)
Tidsramme: 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 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-∞)
Tidsramme: 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.
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)
Tidsramme: 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 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)
Tidsramme: 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 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)
Tidsramme: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
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)
Tidsramme: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
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)
Tidsramme: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
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)
Tidsramme: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
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)
Tidsramme: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2029

Studieafslutning (Anslået)

1. august 2030

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TQB3126-I/II-01

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