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

NCT06418061 | Recruiting Phase 1

• 1 other identifier: CIBI3005A101
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable; Locally Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Numbers of subjects with adverse events

  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

  Up to 3 years

• Number of subjects with clinically significant changes in physical examination results

  Clinically significant abnormal physical examination findings reported by the investigator.

  Up to 3 years

• Number of subjects with clinically significant changes in vital signs

  Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure

  Up to 3 years

• Dose limiting toxicities (DLTs)

  Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.

  Up to 4 weeks

Secondary Outcomes (11)

• area under the curve (AUC)

  up to 3 years

• maximum concentration (Cmax)

  up to 3 years

• time to maximum concentration (Tmax)

  up to 3 years

• clearance (CL)

  up to 3 years

• apparent volume of distribution (V)

  up to 3 years

Study Arms (1)

IBI3005

EXPERIMENTAL

Drug: IBI3005

Interventions

IBI3005 DRUG

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

IBI3005

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shandong Cancer Hospital & Institute

Jinan, Shandong, 250117, China

RECRUITING

Central Study Contacts

Yanxi Pu

CONTACT

18523197816; yanxi.pu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 16, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)