What is IBI354 studying for locally advanced unresectable or metastatic solid tumors?

IBI354 is being studied to assess its safety, tolerability, and appropriate dosing in people with certain advanced solid tumors that cannot be removed by surgery or have spread. Researchers aim to find the best dose and explore how the drug affects tumor response and patient survival. Innovent Biologics sponsors this clinical trial to advance treatment options for these conditions.

Is there any cost to participate in this locally advanced unresectable or metastatic solid tumors clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal expenses such as travel and accommodations may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs during the trial.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID05636215

Phase 12 Open-Label Study of IBI354 in Adults with Advanced or Metastatic Solid Tumors with HER2 Alterations

Q: Who may be eligible for this locally advanced unresectable or metastatic solid tumors clinical trial?

Adults aged 18 years or older with advanced or metastatic solid tumors showing HER2 alterations may be eligible. Both males and females can participate if they have adequate organ function and agree to use effective contraception if applicable. People planning other anti-tumor treatments or with certain infections or unresolved side effects are excluded. Please review eligibility criteria for more details.

Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-03-20

368

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating IBI354, a recombinant anti-HER2 monoclonal antibody-camptothecin derivative conjugate, in people with locally advanced unresectable or metastatic solid tumors. This Phase 12, open-label, multicenter study aims to assess the safety, tolerability, and dose-limiting toxicities to find the maximum tolerated or administered dose and the recommended Phase 2 dose of IBI354. The study also explores the drugs effectiveness and safety in this patient population. Participants receive sequential doses of IBI354 through a single-arm treatment plan. The study includes a Phase 1a dose escalation period to determine safety and dosing limits, followed by Phase 1b2 periods focusing on selected solid tumors expressing HER2. Treatment schedules and dosing details are designed to monitor tolerability and explore efficacy outcomes over time. During the study, participants undergo various assessments including monitoring for adverse events, dose-limiting toxicities within the first 21 days of treatment, and evaluation of objective response rate, duration of response, progression-free survival, and overall survival for up to two years. Safety evaluations continue up to 30 days after the last dose. Participants provide written informed consent and undergo cardiac function monitoring before treatment, with ongoing evaluations throughout their participation, which lasts as long as the study and follow-up periods continue.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female subjects aged 18 years or older
For Phase 1a: Pathologically confirmed advanced/unresectable or metastatic solid tumor with HER2 alterations (IHC 1+, 2+, 3+ and/or ISH+ and/or NGS confirmed mutation or amplification)
For Phase 1b/2: Selected solid tumors with advanced gastric, breast, biliary tract, colorectal, or gynecologic cancers expressing HER2 (IHC 1+, 2+, 3+ and/or ISH+)
Adequate bone marrow and organ function
Not of childbearing potential or agree to use highly effective contraception during study and for 6 months after last dose
Ability to understand and provide written informed consent
Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography within 28 days before study drug administration

You will not qualify if you...

Received anti-tumor therapy within 4 weeks or 5 half-lives before first study drug dose, whichever is shorter
Planning to receive other anti-tumor therapy during study except palliative radiotherapy for symptom relief without impact on tumor assessment
Use of potent CYP3A4 inhibitors within 2 weeks or 5 half-lives before first dose
Unresolved adverse reactions from previous anti-tumor therapies above Grade 1 toxicity except alopecia, fatigue, pigmentation, or other low-risk conditions
Known symptomatic central nervous system metastases
History of pneumonia requiring corticosteroids or clinically significant lung disease or suspicion of such at screening
Uncontrolled infections requiring systemic treatment within 2 weeks before first dose
HIV infection or positive HIV test
Positive hepatitis B or C infection with high viral load
Active COVID-19 infection
Active or recent tuberculosis infection
Active or latent syphilis requiring treatment
Symptomatic congestive heart failure Grade II-IV, uncontrolled arrhythmias, QTc > 480 ms, or congenital long/short QT syndrome
High blood pressure (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
History of arterial thromboembolic events within 6 months
Risk or history of intestinal obstruction, perforation, or inflammatory bowel diseases
Inadequate treatment washout periods before study drug administration for surgery, radiation, transplantation, hormonal therapy, chemotherapy, immunotherapy, or CYP3A4 strong inhibitors as specified

Research Team

yuan lei

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Phase 12 Open-Label Study of IBI354 in Adults with Advanced or Metastatic Solid Tumors with HER2 Alterations

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria