Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06202261
Other study ID # TQB2930-Ib/II-01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 13, 2023
Est. completion date October 2027

Study information

Verified date March 2024
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact Qingyuan Zhang, Doctor
Phone +86 0451 86298070
Email sy86298276@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 154
Est. completion date October 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Drug:
TQB2930 for injection
TQB2930 for injection is a HER2 bispecific antibody.
Paclitaxel for injection (albumin-bound)
It is an anti-microtubule chemotherapy drug
TQB3616 capsule
TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
Fulvestrant injection
Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol
Capecitabine tablets
Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
Vinorelbine tartrate injection
Vinorelbine is an anti-tumor drug of vinca alkaloids.
Eribulin mesylate injection
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.
gemcitabine hydrochloride for injection
Gemcitabine is a cell cycle specific anti-metabolic anticancer agent

Locations

Country Name City State
China Affiliated Cancer Hospital of Chongqing University Chongqing Chongqing
China Affiliated cancer hospital of harbin medical university Harbin Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) The highest dose when dose-limiting toxicity (DLT) occurs in less than 33% of subjects. Baseline up to 4 months
Primary Phase II recommended dose (P2RD) Optimal tolerated dose determined after the end of phase 1 Baseline up to 1 year
Primary Investigators assessed Objective remission rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit. Baseline up to 2 year
Secondary Immunogenicity Incidence of anti-drug antibody (ADA) 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.
Secondary Peak concentration (Cmax), QW The maximum serum concentration after administration 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.
Secondary Peak concentration (Cmax), Q2W The maximum serum concentration after administration 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.
Secondary Peak concentration (Cmax), Q3W The maximum serum concentration after administration 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.
Secondary Overall survival (OS) From randomization to the time of death from any cause. Baseline up to 4 years
Secondary Adverse event rate The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). Baseline up to 2 years
Secondary Progression-free survival (PFS) The time between the first medication and disease progression (PD) or death before PD. Baseline up to 1 year
Secondary Disease control rate (DCR) The ratio of disease control cases (partial remission, complete response, stable disease) to total cases. Baseline up to 2 years
Secondary Duration of remission (DOR) The time from the first evaluation of the tumor as a complete or partial response to the first evaluation as tumor progression or death. Baseline up to 2 years
Secondary Clinical benefit rate (CBR) The ratio of disease control cases (partial remission, complete response, stable disease = 6 month) to total cases. Baseline up to 2 years
Secondary Peak concentration (Cmax), arm 2 The maximum serum concentration after administration in arm 2 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.
Secondary Peak concentration (Cmax), arm 3 and 4 The maximum serum concentration after administration in arm 3 and 4. 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.
See also
  Status Clinical Trial Phase
Withdrawn NCT04872608 - A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer Phase 1
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Completed NCT02506556 - Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer Phase 2
Recruiting NCT05534438 - A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer Phase 2
Recruiting NCT03368729 - Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Completed NCT04103853 - Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer Phase 1
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Active, not recruiting NCT03147287 - Palbociclib After CDK and Endocrine Therapy (PACE) Phase 2
Not yet recruiting NCT06062498 - Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer Phase 2
Recruiting NCT05383196 - Onvansertib + Paclitaxel In TNBC Phase 1/Phase 2
Recruiting NCT04095390 - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer Phase 2
Active, not recruiting NCT04432454 - Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Phase 2
Recruiting NCT03323346 - Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer Phase 2
Recruiting NCT05744375 - Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab Phase 2
Completed NCT02924883 - A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy Phase 2
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Completed NCT01942135 - Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) Phase 3
Active, not recruiting NCT04448886 - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Phase 2
Completed NCT01401959 - Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy Phase 2
Terminated NCT04720664 - Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer Phase 2