Clinical trial NCT06418061: Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Unresectable
Locally Advanced or Metastatic Solid Tumors
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Numbers of subjects with adverse events
timeFrame: Up to 3 years
measure: Number of subjects with clinically significant changes in physical examination results
timeFrame: Up to 3 years
measure: Number of subjects with clinically significant changes in vital signs
timeFrame: Up to 3 years
measure: Dose limiting toxicities (DLTs)
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: area under the curve (AUC)
timeFrame: up to 3 years
measure: maximum concentration (Cmax)
timeFrame: up to 3 years
measure: time to maximum concentration (Tmax)
timeFrame: up to 3 years
measure: clearance (CL)
timeFrame: up to 3 years
measure: apparent volume of distribution (V)
timeFrame: up to 3 years
measure: half-life (t1/2)
timeFrame: up to 3 years
measure: anti-drug antibody (ADA)
timeFrame: up to 3 years
measure: objective response rate (ORR)
timeFrame: up to 3 years
measure: duration of response (DoR)
timeFrame: up to 3 years
measure: time to response (TTR)
timeFrame: up to 3 years
measure: progression free survival (PFS)
timeFrame: up to 3 years
Other outcomes:
Locations:
city: JiNan
country: China
facility: Shandong Cancer Hospital & Institute
state: Shandong
Study officials:
References: