Clinical trial NCT06202261: A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
Official title: A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent / Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Metastatic Breast Cancer
Recurrent Breast Cancer
Advanced Malignancies
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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.

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: Baseline up to 4 months
measure: Phase II recommended dose (P2RD)
timeFrame: Baseline up to 1 year
measure: Investigators assessed Objective remission rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
timeFrame: Baseline up to 2 year
Secondary outcomes:
measure: Immunogenicity
timeFrame: Pre-dose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, each cycle is 21 or 28 days.
measure: Peak concentration (Cmax), QW
timeFrame: Pre-dose, 30 minuets, 4, 8, 24, 48, 72 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 8, each cycle is 21 days.
measure: Peak concentration (Cmax), Q2W
timeFrame: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 15, Cycle 2 Day 15, each cycle is 28 days.
measure: Peak concentration (Cmax), Q3W
timeFrame: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240, 336 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 3 Day 1, each cycle is 21 days.
measure: Overall survival (OS)
timeFrame: Baseline up to 4 years
measure: Adverse event rate
timeFrame: Baseline up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Baseline up to 1 year
measure: Disease control rate (DCR)
timeFrame: Baseline up to 2 years
measure: Duration of remission (DOR)
timeFrame: Baseline up to 2 years
measure: Clinical benefit rate (CBR)
timeFrame: Baseline up to 2 years
measure: Peak concentration (Cmax), arm 2
timeFrame: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 28 days.
measure: Peak concentration (Cmax), arm 3 and 4
timeFrame: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 21 days.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Affiliated Cancer Hospital of Chongqing University
state: Chongqing
city: Harbin
country: China
facility: Affiliated cancer hospital of harbin medical university
state: Heilongjiang
Study officials:
References: