A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors

NCT05636215 | Recruiting Phase 1

• 1 other identifier: CIBI354A101
• Study Type: interventional
• Target: 368
• Locations: 2 countries
• Sites: 6

Brief Summary

This is a Phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI354 (study drug), and to explore and confirm the efficacy, safety and tolerability of IBI354 in subjects with locally advanced unresectable or metastatic solid tumors.

Conditions

Locally Advanced Unresectable or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs).

  An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered.

  Up to 30 days after the last administration

• Number of dose-limiting toxicity (DLT)

  Incidence of dose-limiting toxicity (DLT) events.

  21 days during the first cycle in Phase Ia

Secondary Outcomes (4)

• Objective response rate (ORR)

  Up to 2 years

• duration of response (DoR)

  Up to 2 years

• progression-free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

IBI354

EXPERIMENTAL

Single arm

Biological: IBI354

Interventions

IBI354 BIOLOGICAL

Recombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection

IBI354

Eligibility Criteria

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

You may qualify if:

• Male or female subjects, ≥ 18 years
• Phase 1a : Has a pathologically documented advanced/unresectable or metastatic solid tumor with HER2 alterations (IHC 1+, IHC 2+, IHC 3+ and/or ISH+ and/or NGS confirmed mutant or amplification).
• Phase 1b/2: Selected solid tumors enrolled Subjects with advanced GC/BC/BTC/CRC/Gyn with her2 expression (IHC 1+, IHC 2+, IHC 3+ and/or ISH+).
• Adequate bone marrow and organ function
• Subjects, both male and female, who are either not of childbearing potential or who agree to use at least one highly effective method of contraception during the study (begin from screening or within 2 weeks prior to the first dose, whichever comes first, and continue until 6 months after the last dose of study drug); Subjects, both male and female, who are either not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug
• Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
• Have LVEF ≥ 50% by echocardiography (ECHO) within 28 days before study drug administration.

You may not qualify if:

• Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;
• Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
• Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives (whichever is longer) before first administration of the study drug.
• Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigators' opinion) or baseline prior to first administration of the study drug;
• Known symptomatic central nervous system (CNS) metastases.
• History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging at screening period;
• Uncontrolled diseases including:
• Uncontrolled infection requiring systematic antibiotics, antivirals or antifungals within 2 weeks prior to first administration of the study drug;
• Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
• 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 HCV Ab positive with HCV RNA\>103 copies/mL;
• Active infection with COVID-19;
• 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, symptomatic or uncontrolled arrhythmias, QTc interval \> 480 ms or personal or family history of congenital long/short QT syndrome;
• SBP ≥ 160mmHg or DBP ≥ 100mmHg;

Sponsors & Collaborators

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

Study Sites (6)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

COMPLETED

Westmead Hospital

Sydney, New South Wales, 2145, Australia

COMPLETED

Sunshine Coast University Private Hospital

Sunshine Coast, Queensland, 4575, Australia

COMPLETED

Monash Health

Clayton, Victoria, 3168, Australia

COMPLETED

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Affiliated Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Central Study Contacts

yuan lei

CONTACT

8610-68585566; yuan.lei@innoventbio.com

Study Design

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

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: April 4, 2023
• Primary Completion: April 30, 2025
• Study Completion: October 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); CN (2)