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Clinical Trials in China / NCT06418061
Recruiting Phase 1

Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

NCT06418061 · tracked via the Priya Life Science China tracker
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Phase
Phase 1
Started
2025-01-08
Last updated
2025-01-22

Condition(s) studied

UnresectableLocally Advanced or Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

IBI3005

IBI3005: Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shandong Cancer Hospital & Institute Jinan Shandong Recruiting

More Innovent Biologics (Suzhou) Co. Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06418061 on ClinicalTrials.gov ↗ ← All trials in China