Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IBI3005.
- Who it may be relevant to
- Registry conditions: Unresectable, Locally Advanced or Metastatic Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI3005 in Subjects With Advanced Malignant Solid Tumors
Overview
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
- Drug IBI3005
Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)
Primary outcome measures
- Numbers of subjects with adverse events [Time frame: Up to 3 years]
- Number of subjects with clinically significant changes in physical examination results [Time frame: Up to 3 years]
- Number of subjects with clinically significant changes in vital signs [Time frame: Up to 3 years]
- Dose limiting toxicities (DLTs) [Time frame: Up to 4 weeks]
Secondary outcome measures (11)
- area under the curve (AUC) [Time frame: up to 3 years]
- maximum concentration (Cmax) [Time frame: up to 3 years]
- time to maximum concentration (Tmax) [Time frame: up to 3 years]
- clearance (CL) [Time frame: up to 3 years]
- apparent volume of distribution (V) [Time frame: up to 3 years]
- half-life (t1/2) [Time frame: up to 3 years]
- anti-drug antibody (ADA) [Time frame: up to 3 years]
- objective response rate (ORR) [Time frame: up to 3 years]
- duration of response (DoR) [Time frame: up to 3 years]
- time to response (TTR) [Time frame: up to 3 years]
- progression free survival (PFS) [Time frame: up to 3 years]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shandong Cancer Hospital & Institute — Jinan
Identifiers
NCT: NCT06418061 · CIBI3005A101