Advanced Solid TumorsPhase 1/2NCT05774873

The Primary Objective of This Study to Evaluate the Safety and Tolerability of IBI334 and Determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D)and Anti Tumor Activity of IBI334.

A Phase 1/2 study testing IBI334 in people with Advanced Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is open-label, multicenter, Phase I/II study is designed to evaluate the Safety and tolerability and Efficacy of IBI334 Monotherapy in participants with advanced solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: IBI334
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteChina
Study dates: 9 Aug 2023to 20 Mar 2025
Phase: Phase 1/2
Are there results?: None posted in the registry

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

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;
Male or female subjects ≥ 18 years old;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
Anticipated life expectancy of ≥ 12 weeks;
At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1with Phase Ia ;At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with Phase Ib+II；

Who cannot join

Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;
Severe allergic or hypersensitive to other EGFR or B7H3 antibodies or any ingredients of IBI334;
Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief, which must not affect tumor assessment throughout the study;

Trial locations and contacts

1 site in 1 country.

China1 site

Affiliated Cancer Hospital of Shandong First Medical university
Jinan, Shandong, 250117

Other trials in China

About this study

Official title: A Phase I/II Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

This is open-label, multicenter, Phase I/II study is designed to evaluate the Safety and tolerability and Efficacy of IBI334 Monotherapy in participants with advanced solid tumors.

Conditions: Advanced Solid Tumors
Being tested: IBI334

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IBI334Drug
There are six dose of IBI334 ,QW IV in first cycle and Q2W IV behind the first cycle

Study groups in NCT05774873
Study group	Role	What they receive
IBI334 in advanced solid tumors	Experimental	Not described Receives: Drug: IBI334

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with treatment-related adverse events
Measured: Up to 60 days post last dose
Percentage of subjects woth Dose-Limitine toxicities(DLTs)
Measured: Up to 28 days following first dose

Secondary outcomes (12)

PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: area under the curve (AUC)
Measured: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to:maximum concentration (Cmax)
Measured: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: clearance (CL)
Measured: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: apparent volume of distribution (V)
Measured: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: half-life (t1/2).
Measured: Day 1 up to treatment duration reaches 24 months
Prevalence and incidence of anti-IBI334 antibodies.
Measured: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy ： objective response rate (ORR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Measured: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy : duration of response (DoR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Measured: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy : disease control rate (DCR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Measured: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :time to response (TTR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Measured: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :progression-free survival (PFS) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Measured: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :overall survival (OS)
Measured: Day 1 up to treatment duration reaches 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Aug 202320 Mar 2025

First posted20 Mar 2023
Study start9 Aug 2023
Primary completion20 Mar 2025
Study completion20 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced 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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05774873
Sponsor's protocol ID: CIBI334A101
Status last verified: Dec 2025
First submitted: 8 Feb 2023
Last updated: 6 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Guan J, Chia T, Li B, Zhu T, Liao Z, Deng J, Fu F, Wu W, Liu C, Liu Y, Li N, Yue L, Cao L, Lu J, Zhu M, Ling X, Zheng H, Lin S, Li L, Zhou S, He K. B7-H3-mediated cis-inhibition of EGFR by a tumor-selective bispecific antibody enhances anti-tumor efficacy and minimizes toxicities. Nat Commun. 2026 Feb 24;17(1):3113. doi: 10.1038/s41467-026-69703-7.
PubMed 41735305

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
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RecruitingPhase 1/2
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05774873
Acronym / sponsor ID: CIBI334A101
Conditions: Advanced Solid Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 9 Aug 2023 (actual)
Primary completion: 20 Mar 2025 (actual)
Study completion: 20 Mar 2025 (actual)
First posted: 20 Mar 2023 (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 open-label, multicenter, Phase I/II study is designed to evaluate the Safety and tolerability and Efficacy of IBI334 Monotherapy in participants with advanced 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
IBI334 in advanced solid tumors	Experimental	Drug: IBI334

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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;
Male or female subjects ≥ 18 years old;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
Anticipated life expectancy of ≥ 12 weeks;
At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1with Phase Ia ;At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with Phase Ib+II；

Key exclusion criteria (5 listed)

Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;
Severe allergic or hypersensitive to other EGFR or B7H3 antibodies or any ingredients of IBI334;
Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief, which must not affect tumor assessment throughout the study;

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
IBI334There are six dose of IBI334 ,QW IV in first cycle and Q2W IV behind the first cycle	Drug	IBI334 in advanced solid tumors

Primary outcome

Number of patients with treatment-related adverse events
Time frame: Up to 60 days post last dose
Percentage of subjects woth Dose-Limitine toxicities(DLTs)
Time frame: Up to 28 days following first dose

12 secondary outcomes

PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: area under the curve (AUC)
Time frame: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to:maximum concentration (Cmax)
Time frame: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: clearance (CL)
Time frame: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: apparent volume of distribution (V)
Time frame: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: half-life (t1/2).
Time frame: Day 1 up to treatment duration reaches 24 months
Prevalence and incidence of anti-IBI334 antibodies.
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy ： objective response rate (ORR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy : duration of response (DoR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy : disease control rate (DCR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :time to response (TTR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :progression-free survival (PFS) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :overall survival (OS)
Time frame: Day 1 up to treatment duration reaches 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Derived from this study: PubMed 41735305Guan J, Chia T, Li B, Zhu T, Liao Z, Deng J, Fu F, Wu W, Liu C, Liu Y, Li N, Yue L, Cao L, Lu J, Zhu M, Ling X, Zheng H, Lin S, Li L, Zhou S, He K. B7-H3-mediated cis-inhibition of EGFR by a tumor-selective bispecific antibody enhances anti-tumor efficacy and minimizes toxicities. Nat Commun. 2026 Feb 24;17(1):3113. doi: 10.1038/s41467-026-69703-7.

Related trials for Advanced Solid Tumors

RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IBI334 in people with Advanced Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

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 5 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with treatment-related adverse events (time frame: Up to 60 days post last dose). 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?

On the ClinicalTrials.gov record for NCT05774873, which also lists 1 linked publication.

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 6 Jan 2026.