Locally Advanced or Metastatic Solid Tumors, Unresectable
Conditions
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.
Interventions
DRUGIBI3005
Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D code: IBI3005)
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| anti-drug antibody (ADA) | up to 3 years | Incidence and characterization of anti-drug antibody (ADA). |
| 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. |
| 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. |
| objective response rate (ORR) | up to 3 years | objective response rate (ORR) 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 maximum concentration (Tmax) | up to 3 years | time to maximum concentration (Tmax) of single and multiple doses of IBI3005 |
| clearance (CL) | up to 3 years | clearance (CL) of single and multiple doses of IBI3005 |
Countries
China
Contacts
Primary ContactYanxi Pu
Outcome results
None listed