Advanced Solid TumorsPhase 1NCT05164458
Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies
A Phase 1 study testing IBI 308 injection and IBI 389 Injection in people with Advanced Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of IBI389 as a single agent, and in combination with sintilimab, and (or) chemotherapy in patients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- IBI 308 injection and IBI 389 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2022to 30 Sep 2024
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed informed consent;
- Male or female aged at 18-75 (inclusive) years;
- Expected survival ≥12 weeks;
- ECOG PS score 0 or 1;
- Provide archival or fresh tissues for CLDN18.2 expression analysis;
- Adequate laboratory parameters;
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- Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
- Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
- Ib: pancreatic carcinoma, gastric adenocarcinoma, advanced or metastatic solid tumors
Who cannot join
- Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.
- Any investigational drugs received within 4 weeks prior to the first study treatment.
- Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
- Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
- Medication requiring long-term systemic hormones or any other immunosuppression therapy.
- Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.
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- There was unrecovered toxicity (excluding hair loss or fatigue) according to NCI CTCAE v5.0 induced by previous antitumor therapy (24 weeks before the first dose of study), and there were unrecovered immune-related adverse events (irAE) associated with immunotherapy.
- Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
- History of autoimmune disease , present active autoimmune disease or inflammatory diseases
- Present or history of pulmonary diseases such as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pulmonary fibrosis, active pulmonary infection, severely impaired pulmonary function.
- Positive human immunodeficiency virus (HIV) test.
- Active hepatitis B or C, or tuberculosis.
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- History of gastrointestinal perforation and/or fistula at 6 months prior to study inclusion.
- Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiring drainage.
- Known history of hypersensitivity to any components of the IBI389 or Sintilimab.
- Uncontrolled complications of disease.
- Other acute or chronic illness, mental illness, or abnormal laboratory test values that may increase the risk of study participation or administration of study drugs, or interfere with the interpretation of study results.
- Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
bi feng, 028-85422114, bifeng@csco.org.cn
About this study
Official title: A Phase Ia/Ib, Open Label, Multicenter Study of the Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, Administered to Patients With Advanced Malignancies
This study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of IBI389 as a single agent, and in combination with sintilimab, and (or) chemotherapy in patients with advanced or metastatic solid tumors.
Read the detailed description
The study consists of a dose escalation phase (Ia) and a dose expansion phase (Ib). Phase Ia is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for IBI389 as a single agent, and in combination with sintilimab. Phase (Ib) is a multi-cohort trial of CLDN18.2 positive solid tumors to evaluate safety and preliminary efficacy of IBI389 in combination with sintilimab and (or) chemotherapy or IBI389 monotherapy.
- Conditions
- Advanced Solid Tumors
- Being tested
- IBI 308 injection, IBI 389 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI 308 injectionDrug
IBI308 IV 200mg Q3W Day1
IBI 389 InjectionDrug
IBI 389 IV Q2~Q3W Day 1
| Study group | Role | What they receive |
|---|---|---|
| IBI389 | Experimental | A dose escalation stage of IBI 389 monotherapy. Receives: Drug: IBI 389 Injection |
| IBI 389 + sintilimab | Experimental | A dose escalation stage of IBI 389 in combination with sintilimab. Receives: Drug: IBI 308 injection; Drug: IBI 389 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with AEs and SAEs
To evaluate the safety and tolerability of IBI389 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ]
Measured: up to 2 years after enrollment
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
To evaluate the safety and tolerability of IBI389 alone or in combination with Sintilimab.
Measured: up to 28 Days following first dose
Secondary outcomes (4)
Pharmacokinetics: AUC
The area under the curve (AUC) of serum concentration of the drug after the administration.
Measured: up to 2 years after enrollment
Cmax
Maximum concentration (Cmax) of the drug after administration
Measured: up to 2 years after enrollment
Immunogenicity: Percentage of ADA positive subjects
Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI389.
Measured: up to 2 years after enrollment
Preliminary anti-tumor activity of IBI389 (Objective Response Rate)
Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors.
Measured: up to 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start22 Mar 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 320 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
- NCT05164458
- Sponsor's protocol ID
- CIBI389A101
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2021
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Dai R, Xu Q, Guo Z, Hu C, Sun Y, Niu Z, Hao J, Zhang M, Dai G, Hua D, Pan Y, Wang X, Wei S, Chen X, Wu Q, Zhang Y, Zhou H, Ying J, Zheng L, Bi F. Safety and preliminary efficacy results of IBI389, an anti-Claudin18.2xCD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: a phase 1 dose escalation and expansion study. BMC Med. 2026 Jan 16;24(1):91. doi: 10.1186/s12916-025-04597-8.
PubMed 41540424
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Open Label, Multicenter Study of the Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, Administered to Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05164458
- Acronym / sponsor ID
- CIBI389A101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 20 Dec 2021 (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 study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of IBI389 as a single agent, and in combination with sintilimab, and (or) chemotherapy in patients with advanced or metastatic solid tumors.
Detailed description
The study consists of a dose escalation phase (Ia) and a dose expansion phase (Ib). Phase Ia is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for IBI389 as a single agent, and in combination with sintilimab. Phase (Ib) is a multi-cohort trial of CLDN18.2 positive solid tumors to evaluate safety and preliminary efficacy of IBI389 in combination with sintilimab and (or) chemotherapy or IBI389 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI389 | Experimental | Drug: IBI 389 InjectionA dose escalation stage of IBI 389 monotherapy. |
| IBI 389 + sintilimab | Experimental | Drug: IBI 308 injection, Drug: IBI 389 InjectionA dose escalation stage of IBI 389 in combination with sintilimab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide signed informed consent;
- Male or female aged at 18-75 (inclusive) years;
- Expected survival ≥12 weeks;
- ECOG PS score 0 or 1;
- Provide archival or fresh tissues for CLDN18.2 expression analysis;
Key exclusion criteria (19 listed)
- Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.
- Any investigational drugs received within 4 weeks prior to the first study treatment.
- Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
- Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
- Medication requiring long-term systemic hormones or any other immunosuppression therapy.
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 |
|---|---|---|
| IBI 308 injectionIBI308 IV 200mg Q3W Day1 | Drug | IBI 389 + sintilimab |
| IBI 389 InjectionIBI 389 IV Q2~Q3W Day 1 | Drug | IBI 389 + sintilimab, IBI389 |
Primary outcome
Number of subjects with AEs and SAEs
Time frame: up to 2 years after enrollment
To evaluate the safety and tolerability of IBI389 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ]
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: up to 28 Days following first dose
To evaluate the safety and tolerability of IBI389 alone or in combination with Sintilimab.
4 secondary outcomes
Pharmacokinetics: AUC
Time frame: up to 2 years after enrollment
Cmax
Time frame: up to 2 years after enrollment
Immunogenicity: Percentage of ADA positive subjects
Time frame: up to 2 years after enrollment
Preliminary anti-tumor activity of IBI389 (Objective Response Rate)
Time frame: up to 2 years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Derived from this study: PubMed 41540424Li X, Dai R, Xu Q, Guo Z, Hu C, Sun Y, Niu Z, Hao J, Zhang M, Dai G, Hua D, Pan Y, Wang X, Wei S, Chen X, Wu Q, Zhang Y, Zhou H, Ying J, Zheng L, Bi F. Safety and preliminary efficacy results of IBI389, an anti-Claudin18.2xCD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: a phase 1 dose escalation and expansion study. BMC Med. 2026 Jan 16;24(1):91. doi: 10.1186/s12916-025-04597-8.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI 308 injection and IBI 389 Injection 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 9 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiaoqin ruan (18610683729, xiaoqin.ruan@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with AEs and SAEs (time frame: up to 2 years after enrollment). 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 NCT05164458, 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 28 Dec 2023.