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RecruitingLast updated: 2 February 2024

This study is evaluating how safe, tolerable and effective the a new immunotherapy (IBI354) is in people with locally advanced inoperable or metastatic solid cancersA Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

Clinical summary

Summary

This phase I/II study is designed to evaluate the safety, tolerability and establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the recommended phase 2 dose (RP2D) of sequential doses of IBI354, and to explore and confirm the efficacy, safety and tolerability of IBI354 in people with locally advanced unresectable or metastatic solid tumours. IBI354 is a recombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection.

Conditions

This trial is treating patients with advanced solid cancers with HER2 alterations

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Scientific Title

A Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

Eligibility

Inclusion

  1. Male or female subjects, ≥ 18 years
  2. 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+).

  3. Adequate bone marrow and organ function
  4. 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
  5. 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;
  6. Have LVEF ≥ 50% by echocardiography (ECHO) within 28 days before study drug administration.

Exclusion

  1. 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;
  2. 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;
  3. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives (whichever is longer) before first administration of the study drug.
  4. 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;
  5. Known symptomatic central nervous system (CNS) metastases.
  6. 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;
  7. 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;
  8. History of any arterial thromboembolic event within 6 months prior to the first administration of study drug, including myocardial infarction, unstable angina pectoris, cerebrovascular stroke or transient ischemic attack, etc.;
  9. Risk of intestinal obstruction or perforation (including but not limited to: acute diverticulitis, abdominal abscess, etc.) or a history of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or chronic diarrhea;
  10. Do not have adequate treatment washout period before study drug administration, defined as:

    • Major surgery; ≥ 4 weeks.
    • Radiation therapy;≥ 4 weeks (if palliative stereotactic radiation therapy, ≥ 2 weeks).
    • Autologous transplantation;≥ 3 months.
    • Hormonal therapy;≥ 2 weeks.
    • Chemotherapy (including antibody drug therapy or other antitumor therapy); ≥ 3 weeks.
    • Immunotherapy; ≥ 4 weeks.
    • Cytochrome P450 (CYP) 3A4 strong inhibitor;≥ 3 elimination half-lives of the inhibitor.

Inclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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