Study of IBI3005 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors
- Conditions
- UnresectableLocally Advanced or Metastatic Solid Tumors
- Interventions
- Registration Number
- NCT06418061
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 198
Subjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression.
Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines.
Uncontrolled diseases including:
- Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）;
- Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
- Acute or chronic active hepatitis B (HbsAg positive and/or HbcAb positive with HBV DNA titer ≥ 104 copies/mL or ≥ 2000 IU/mL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer > 103 copies/mL or higher than lower limit of detection);
- Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;
- Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti tuberculosis therapy within 1 year prior to first administration of the study drug;
- Active syphilis infection or latent syphilis requiring treatment;
- Symptomatic congestive heart failure Grade II-IV (New York Heart Association [NYHA]), symptomatic or uncontrolled arrhythmias, QTc interval > 480 ms or personal or family history of congenital long/short QT syndrome;
- Hypertension that does not receive standardized therapy or still uncontrollable hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg); Any history of life-threatening hemorrhage, or hemorrhage requiring (including but not limited to gastrointestinal bleeding, hemoptysis, etc) blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of study drug;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description IBI3005 IBI3005 -
- Primary Outcome Measures
Name Time Method Numbers of subjects with adverse events Up to 3 years defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with clinically significant changes in physical examination results Up to 3 years Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs Up to 3 years Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Dose limiting toxicities (DLTs) Up to 4 weeks Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
- Secondary Outcome Measures
Name Time Method anti-drug antibody (ADA) up to 3 years Incidence and characterization of anti-drug antibody (ADA).
clearance (CL) up to 3 years clearance (CL) of single and multiple doses of IBI3005
apparent volume of distribution (V) up to 3 years apparent volume of distribution (V) of single and multiple doses of IBI3005
half-life (t1/2) up to 3 years half-life (t1/2) of IBI3005 to the last administration of IBI3005
objective response rate (ORR) up to 3 years objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
area under the curve (AUC) up to 3 years area under the curve (AUC) of single and multiple doses of IBI3005
duration of response (DoR) up to 3 years duration of response (DoR) as evaluated per the RECIST v1.1 criteria.
maximum concentration (Cmax) up to 3 years maximum concentration (Cmax) of single and multiple doses of IBI3005
time to response (TTR) up to 3 years time to response (TTR) as evaluated per the RECIST v1.1 criteria.
progression free survival (PFS) up to 3 years as evaluated per the RECIST v1.1 criteria.
time to maximum concentration (Tmax) up to 3 years time to maximum concentration (Tmax) of single and multiple doses of IBI3005
Trial Locations
- Locations (1)
Shandong Cancer Hospital & Institute
🇨🇳JiNan, Shandong, China