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Trial Title:
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
NCT ID:
NCT06202261
Condition:
Metastatic Breast Cancer
Recurrent Breast Cancer
Advanced Malignancies
Conditions: Official terms:
Breast Neoplasms
Recurrence
Paclitaxel
Vinorelbine
Gemcitabine
Capecitabine
Fulvestrant
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2930 for injection
Description:
TQB2930 for injection is a HER2 bispecific antibody.
Arm group label:
TQB2930 for injection
Arm group label:
TQB2930 for injection + chemotherapy
Arm group label:
TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)
Arm group label:
TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection
Intervention type:
Drug
Intervention name:
Paclitaxel for injection (albumin-bound)
Description:
It is an anti-microtubule chemotherapy drug
Arm group label:
TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)
Intervention type:
Drug
Intervention name:
TQB3616 capsule
Description:
TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
Arm group label:
TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection
Intervention type:
Drug
Intervention name:
Fulvestrant injection
Description:
Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to
estradiol
Arm group label:
TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection
Intervention type:
Drug
Intervention name:
Capecitabine tablets
Description:
Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
Arm group label:
TQB2930 for injection + chemotherapy
Intervention type:
Drug
Intervention name:
Vinorelbine tartrate injection
Description:
Vinorelbine is an anti-tumor drug of vinca alkaloids.
Arm group label:
TQB2930 for injection + chemotherapy
Intervention type:
Drug
Intervention name:
Eribulin mesylate injection
Description:
Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately
apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic
mechanism.
Arm group label:
TQB2930 for injection + chemotherapy
Intervention type:
Drug
Intervention name:
gemcitabine hydrochloride for injection
Description:
Gemcitabine is a cell cycle specific anti-metabolic anticancer agent
Arm group label:
TQB2930 for injection + chemotherapy
Summary:
This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and
expansion study of monotherapy, as well as the dose escalation study of combination
therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is
conducted to observe the safety and efficacy in monotherapy. Phase II study is to further
observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3),
or chemotherapy selected by investigators (cohort 4).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG
PS) score: 0~1; The expected survival is over 3 months.
- Phase Ib
1. Advanced malignancies confirmed by cytology / histopathology, priority given to
subjects with HER2 expression or amplification;
2. Subjects with malignant tumors who have failed standard treatment or lack
effective treatment;
3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1
criteria
- Phase II
1. Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by
cytology / histopathology, with evidence of local recurrence or distant
metastasis, unsuitable for surgery or radiotherapy for curative purposes:
2. Have not received systemic antitumor therapy for metastatic stage; Systemic use
of endocrine therapy is permitted, but not exceed 2 lines;
3. at least one measurable lesion that meets the RECIST 1.1 criteria.
- Major organs are functioning normally.
- Female subjects of reproductive age should agree to use contraceptive methods during
the study period and until 6 months after the end of the study; Negative serum
pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be
non-lactating subjects; Male subjects should agree to use contraception during the
study and until six months after the end of the study.
Exclusion Criteria:
- Have occured other malignant tumors within 3 years prior to first dose.
- Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE)
grade 1 due to any prior treatment;
- Received major surgical treatment, open biopsy, or significant traumatic injury
within 28 days prior to the first dose;
- Long-term unhealed wounds or fractures;
- Arterial/venous thrombosis events occurred within 6 months before the first dose;
- Have a history of psychotropic drug abuse and can't get rid of it or have mental
disorders;
- Subject with any severe and/or uncontrolled disease;
- Subjects who have been treated with other antitumor agents such as chemotherapy,
radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5
half-lives of the drug;
- Have used traditional chinese medicine with anti-tumor indications approved by
National Medical Products Administration (NMPA) within 2 weeks before the first
dose;
- Severe bone injury due to bone metastasis;
- Subjects with untreated active brain metastases or meningeal metastases or cancerous
meningitis;
- In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions
(LVEF) decreased to <50% or absolute LVEF decreased >15%;
- Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes
>360 mg/m2;
- Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued
bisphosphonate therapy
- Patients with severe hypersensitivity after the use of monoclonal antibodies;
- Has participated in other antitumor clinical trials within 4 weeks prior to the
first dose.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Cancer Hospital of Chongqing University
Address:
City:
Chongqing
Zip:
400000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Zeng
Phone:
13983687701
Email:
zengxiaohua000017@163.com
Facility:
Name:
Affiliated cancer hospital of harbin medical university
Address:
City:
Harbin
Zip:
150001
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingyuan Zhang, Doctor
Phone:
+86 0451 86298070
Email:
sy86298276@163.com
Start date:
April 13, 2023
Completion date:
October 2027
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06202261
