Locally Advanced Unresectable or Metastatic Solid TumorsPhase 1/2NCT05636215
A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors
A Phase 1/2 study testing IBI354 in people with Locally Advanced Unresectable or Metastatic Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Unresectable or Metastatic Solid Tumors
- What is being tested?
- IBI354
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 4 Apr 2023to 31 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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.;
- 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;
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Australia4 sites
- Completed
Monash Health
Clayton, Victoria, 3168
- Completed
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
- Completed
Sunshine Coast University Private Hospital
Sunshine Coast, Queensland, 4575
- Completed
Westmead Hospital
Sydney, New South Wales, 2145
China2 sites, 2 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, 010-88196090, doctorshenlin@sina.cn
- Recruiting
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, 400030
Zhou Qi, 023-65311341, qizhou9128@163.com
About this study
Official title: A Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors
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.
- Being tested
- IBI354
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI354Biological
Recombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection
| Study group | Role | What they receive |
|---|---|---|
| IBI354 | Experimental | Single arm Receives: Biological: IBI354 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after the last administration
Number of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) events.
Measured: 21 days during the first cycle in Phase Ia
Secondary outcomes (4)
Objective response rate (ORR)
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR).
Measured: Up to 2 years
duration of response (DoR)
DoR is defined as the time from the date of first documented tumor response (CR/PR) until PD/death.
Measured: Up to 2 years
progression-free survival (PFS)
PFS is defined as the time from the date of first dose of study drug to the date of the first documented progression or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Overall survival (OS)
OS is defined as the time from the date of first dose of study drug until the date of death from any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start4 Apr 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636215
- Sponsor's protocol ID
- CIBI354A101
- Status last verified
- Mar 2025
- First submitted
- 23 Nov 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05636215
- Acronym / sponsor ID
- CIBI354A101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI354 | Experimental | Biological: IBI354Single arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI354Recombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection | Biological | IBI354 |
Primary outcome
Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs).
Time frame: Up to 30 days after the last administration
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.
Number of dose-limiting toxicity (DLT)
Time frame: 21 days during the first cycle in Phase Ia
Incidence of dose-limiting toxicity (DLT) events.
4 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 2 years
duration of response (DoR)
Time frame: Up to 2 years
progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IBI354 in people with Locally Advanced Unresectable or Metastatic Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuan lei (8610-68585566, yuan.lei@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs). (time frame: Up to 30 days after the last administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.