Study of IBI3005 in Subjects with Unresectable, Locally Advanced or Metastatic 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

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced or Metastatic Solid Tumors; Unresectable
• Intervention / Treatment: Drug: IBI3005

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yanxi Pu; Phone Number: 18523197816; Email: yanxi.pu@innoventbio.com

Study Locations

• China
  • Shandong
    • JiNan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital & Institute
      • Contact: Yuping Sun, M.D.
      • Contact: Jinming Yu; Phone Number: 13806406293; Email: sdyujinming@126.com
      • Contact: Yuping Sun; Phone Number: 13370582181; Email: 13370582181@126.com
      • Contact: Jinming Yu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI3005	Drug: IBI3005; Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D code: IBI3005)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose limiting toxicities (DLTs)	Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.	Up to 4 weeks
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
area under the curve (AUC)	area under the curve (AUC) of single and multiple doses of IBI3005	up to 3 years
maximum concentration (Cmax)	maximum concentration (Cmax) of single and multiple doses of IBI3005	up to 3 years
time to maximum concentration (Tmax)	time to maximum concentration (Tmax) of single and multiple doses of IBI3005	up to 3 years
clearance (CL)	clearance (CL) of single and multiple doses of IBI3005	up to 3 years
apparent volume of distribution (V)	apparent volume of distribution (V) of single and multiple doses of IBI3005	up to 3 years
half-life (t1/2)	half-life (t1/2) of IBI3005 to the last administration of IBI3005	up to 3 years
anti-drug antibody (ADA)	Incidence and characterization of anti-drug antibody (ADA).	up to 3 years
objective response rate (ORR)	objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.	up to 3 years
duration of response (DoR)	duration of response (DoR) as evaluated per the RECIST v1.1 criteria.	up to 3 years
time to response (TTR)	time to response (TTR) as evaluated per the RECIST v1.1 criteria.	up to 3 years
progression free survival (PFS)	as evaluated per the RECIST v1.1 criteria.	up to 3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI3005A101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No