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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
TQB2930 for injection is a HER2 bispecific antibody.
It is an anti-microtubule chemotherapy drug
TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol
Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
Vinorelbine is an anti-tumor drug of vinca alkaloids.
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 is a cell cycle specific anti-metabolic anticancer agent
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China
RECRUITINGAffiliated cancer hospital of harbin medical university
Harbin, Heilongjiang, China
RECRUITINGMaximum tolerated dose (MTD)
The highest dose when dose-limiting toxicity (DLT) occurs in less than 33% of subjects.
Time frame: Baseline up to 4 months
Phase II recommended dose (P2RD)
Optimal tolerated dose determined after the end of phase 1
Time frame: Baseline up to 1 year
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.
Time frame: Baseline up to 2 year
Immunogenicity
Incidence of anti-drug antibody (ADA)
Time frame: 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.
Peak concentration (Cmax), QW
The maximum serum concentration after administration
Time frame: 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.
Peak concentration (Cmax), Q2W
The maximum serum concentration after administration
Time frame: 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.
Peak concentration (Cmax), Q3W
The maximum serum concentration after administration
Time frame: 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.
Overall survival (OS)
From randomization to the time of death from any cause.
Time frame: Baseline up to 4 years
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 2 years
Progression-free survival (PFS)
The time between the first medication and disease progression (PD) or death before PD.
Time frame: Baseline up to 1 year
Disease control rate (DCR)
The ratio of disease control cases (partial remission, complete response, stable disease) to total cases.
Time frame: Baseline up to 2 years
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.
Time frame: Baseline up to 2 years
Clinical benefit rate (CBR)
The ratio of disease control cases (partial remission, complete response, stable disease ≥ 6 month) to total cases.
Time frame: Baseline up to 2 years
Peak concentration (Cmax), arm 2
The maximum serum concentration after administration in arm 2
Time frame: 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.
Peak concentration (Cmax), arm 3 and 4
The maximum serum concentration after administration in arm 3 and 4.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.