To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.
Has signed a written informed consent form (ICF) and is able to comply with the scheduled study visits and related procedures.
Age ≥ 18 years, irrespective of gender.
Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor.
Expected survival ≥ 12 weeks.
Participation in any other interventional clinical study, except for observational (non-interventional) studies or the follow-up period after the end of study treatment in an interventional study.
Prior treatment with antibody-drug conjugate (ADC) drugs bearing a camptothecin or its derivative (topoisomerase I inhibitor) small-molecule payload.
Prior to the first dose of study drug: a) Within 4 weeks: Received intravenous chemotherapy, macromolecular targeted therapy, antibody-drug conjugates, immunotherapy, endocrine therapy, cell therapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy. b) Within 2 weeks or 5 half-lives (whichever is shorter): Received oral chemotherapy, small-molecule targeted therapy, or traditional Chinese herbal medicines indicated for anti-tumor treatment. c) Within 4 weeks: Received radical radiotherapy; within 2 weeks: Received palliative radiotherapy. d) Within 2 weeks or 5 half-lives (whichever is shorter): Received strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4). e) Within 4 weeks: Underwent major surgery (craniotomy, thoracotomy, laparotomy, or other surgeries deemed ""major"" by the investigator, excluding puncture biopsy), or has severe unhealed wounds, trauma, or ulcers; within 2 weeks: Underwent laparoscopic exploratory surgery. f) Within 4 weeks: Received live vaccine (mRNA and non-replicating adenovirus vaccines are not considered live vaccines).
Presence of adverse events from prior anti-tumor therapy that have not resolved to Grade 0 or 1 per NCI-CTCAE v5.0 [excluding Grade 2 alopecia, fatigue, pigmentation, insomnia, peripheral neuropathy, hypomagnesemia, and toxicities stably controlled by medication (e.g., hypothyroidism stably controlled by replacement therapy, hypertension with blood pressure stably controlled below 160/100 mmHg by antihypertensive medication)].
Single group
IBI3005
DrugBispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)
Sintilimab
DrugAnti-PD-1 Monoclonal Antibody
Bevacizumab biosimilar
DrugRecombinant humanized anti-VEGF monoclonal antibody
Limertinib
DrugThird-generation EGFR-TKI
Osimertinib
DrugThird-generation EGFR-TKI
Carboplatin
DrugSecond-generation platinum-based chemotherapy drugs
Number of subjects with adverse events
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with treatment emergent adverse events
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with adverse events of special interest
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with serious adverse events
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
area under the curve (AUC)
area under the curve (AUC) of single and multiple doses of IBI3005
maximum concentration (Cmax)
maximum concentration (Cmax) of single and multiple doses of IBI3005
time to maximum concentration (Tmax)
time to maximum concentration (Tmax) of single and multiple doses of IBI3005
clearance (CL)
clearance (CL) of single and multiple doses of IBI3005
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