Evaluating IBI3005 for advanced solid tumors

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

This study is testing a new drug called IBI3005 to see if it is safe and how much of it can be given to people with advanced solid tumors that haven't responded to previous treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06418061 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of IBI3005 in patients with unresectable, locally advanced, or metastatic solid tumors. It will determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of the drug. Participants must have previously been treated with a third-generation EGFR TKI and experienced disease progression. The study will exclude patients with uncontrolled diseases or certain infections.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable, locally advanced, or metastatic solid tumors who have progressed after treatment with a third-generation EGFR TKI.

Not a fit: Patients with uncontrolled diseases or active infections, as well as those who have received live vaccines recently, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches targeting advanced solid tumors, but the specific use of IBI3005 is novel.

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;

Where this trial is running

Jinan, Shandong

• Shandong Cancer Hospital & Institute — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Yanxi Pu

Conditions: Unresectable, Locally Advanced or Metastatic Solid Tumors