This is a multicenter, open Phase Ib/II clinical study evaluating the safety and efficacy of TQB2922 in combination with TAS-102±bevacizumab in subjects with RAS/BRAF wild-type unresectable locally advanced or metastatic colorectal cancer that has failed treatment with oxaliplatin, fluorouracil-based and irinotecan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
TQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype Immunoglobulin G1 (IgG1). TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells.
TQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype IgG1. TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGNational Cancer Center/Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGZhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
Dose limiting toxicity (DLT)
One or more unacceptable toxic reactions following administration of the drug, resulting in the inability to continue increasing the dose or prolonging the dosing cycle.
Time frame: Baseline up to 48 weeks
Objective Response Rate (ORR)
Proportion of patients with tumour volume reduction to a pre-specified value that maintains the minimum timeframe requirement.
Time frame: Complete response time was achieved, evaluation is expected to take 1 years.
Maximum tolerated dose (MTD)
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
Time frame: Baseline up to 48 weeks
Incidence of adverse event (AE) and serious adverse event (SAE)
The incidence and severity of adverse events were determined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 rating scale
Time frame: Baseline up to 48 weeks
Disease Control Rate (DCR)
The proportion of subjects who achieved complete response (CR), partial response (PR), or stable disease (SD) was assessed.
Time frame: Complete response time was achieved, evaluation is expected to take 1 years.
Recommended Phase 2 Dose
The dose recommended for Phase 2 trials based on Phase 1 safety, tolerability, and pharmacokinetic data.
Time frame: Baseline up to 48 weeks
Elimination Half-life
The time required for the plasma concentration of a drug to decrease by 50% during the elimination phase, reflecting metabolic and excretory rates.
Time frame: Baseline up to 48 weeks
Area Under the Curve
The integral of the drug concentration-time curve in plasma, representing total systemic drug exposure.
Time frame: Baseline up to 48 weeks
Apparent Clearance
The apparent volume of plasma cleared of the drug per unit time, typically expressed in L/h.
Time frame: Baseline up to 48 weeks
Apparent Volume of Distribution in Terminal Phase
The apparent volume in which a drug is distributed during the terminal phase, calculated based on plasma concentration, indicating tissue distribution extent.
Time frame: Baseline up to 48 weeks
Trough Concentration
The plasma drug concentration measured at the end of a dosing interval (before next administration), used to assess accumulation risk.
Time frame: Baseline up to 48 weeks
Duration of Response
Time from first documented objective response (e.g., tumor shrinkage) to disease progression or death.
Time frame: Complete response time was achieved, evaluation is expected to take 1 years.
Progression-Free Survival
Time from enrollment to disease progression or death from any cause, evaluating treatment's disease control ability.
Time frame: 1 year of assessment is expected from the start of enrolment to the first occurrence of disease progression or death from any cause
Incidence of Anti-Drug Antibody
The proportion of patients developing antidrug antibodies during treatment, indicating immunogenicity risk.
Time frame: Baseline up to 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGMeizhou People's Hospital
Meizhou, Guangdong, China
NOT_YET_RECRUITINGShantou University Medical College Affiliated Cancer Hospital
Shantou, Guangdong, China
NOT_YET_RECRUITINGGuangxi Zhuang Autonomous Region Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGXinyang Central Hospital
Xinyang, Henan, China
NOT_YET_RECRUITING...and 17 more locations