Solid TumorPhase 1/2NCT05991349
A Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing IBI129 in people with Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 7 sites in 2 countries.
Trial summary
This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- IBI129
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 12 Mar 2024to 31 May 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;
- At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.;
- 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;
- Adequate bone marrow and organ function
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 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.
- Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor.
- 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;
- Known symptomatic central nervous system (CNS) metastases.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
China4 sites
The First Hospital of Jilin University
Changchun, Jilin, 130021
Shandong Cancer Hospital
Jinan, Shandong, 250117
Tianjin Medical university cancer institute & Hospital
Tianjin, Tianjin Municipality, 300000
Hubei Cancer Hospital
Wuhan, Hubei
Australia3 sites
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
St George private Hospital
Kogarah, New South Wales, 2217
Wollongong Hospital
Wollongong, New South Wales, 2500
About this study
Official title: A Phase 1/2 Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2
- Conditions
- Solid Tumor
- Being tested
- IBI129
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI129Drug
Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| IBI129 | Experimental | IBI129 Receives: Drug: IBI129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
Measured: 24 months
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Measured: 24 months
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Measured: 24 months
MTD or RP2D of IBI129
Number of subjects with dose-limiting toxicities (DLTs)
Measured: 12 months
Secondary outcomes (13)
Plasma concentration (Cmax) of IBI129
Plasma concentration of IBI129 for single and multiple doses.
Measured: 12 months
Area under the curve (AUC) of IBI129
AUC of IBI129 for single and multiple doses.
Measured: 12 months
Time to maximum concentration (Tmax) of IBI129
Tmax of IBI129 for single and multiple doses.
Measured: 12 months
Clearance (CL) of IBI129
Clearance of IBI129 from the plasma
Measured: 12 months
Volume of distribution (V) of IBI129
Apparent volume of distribution of IBI129.
Measured: 12 months
Half-life (T1/2) of IBI129
T1/2 of IBI129 for single and multiple doses.
Measured: 12 months
Immunogenicity of IBI129
Incidence of anti-drug (IBI129) antibody
Measured: 12 months
Objective response rate (ORR)
ORR as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Duration of response (DoR)
DoR as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Disease control rate (DCR)
DCR as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Time to response (TTR)
TTR as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Progression free survival (PFS)
PFS as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Overall survival (OS)
Overall survival.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 Mar 2024
- Primary completion30 Nov 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 36 participants (actual)
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
- NCT05991349
- Sponsor's protocol ID
- CIBI129A101
- Status last verified
- Nov 2025
- First submitted
- 25 Jul 2023
- Last updated
- 24 Jun 2026
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05991349
- Acronym / sponsor ID
- CIBI129A101
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 14 Aug 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 a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI129 | Experimental | Drug: IBI129IBI129 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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;
- At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.;
- 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;
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 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.
- Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor.
- 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;
- 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 |
|---|---|---|
| IBI129Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first. | Drug | IBI129 |
Primary outcome
Number of subjects with adverse events
Time frame: 24 months
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
Number of subjects with clinically significant changes in physical examination results
Time frame: 24 months
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
Time frame: 24 months
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
MTD or RP2D of IBI129
Time frame: 12 months
Number of subjects with dose-limiting toxicities (DLTs)
13 secondary outcomes
Plasma concentration (Cmax) of IBI129
Time frame: 12 months
Area under the curve (AUC) of IBI129
Time frame: 12 months
Time to maximum concentration (Tmax) of IBI129
Time frame: 12 months
Clearance (CL) of IBI129
Time frame: 12 months
Volume of distribution (V) of IBI129
Time frame: 12 months
Half-life (T1/2) of IBI129
Time frame: 12 months
Immunogenicity of IBI129
Time frame: 12 months
Objective response rate (ORR)
Time frame: 24 months
Duration of response (DoR)
Time frame: 24 months
Disease control rate (DCR)
Time frame: 24 months
Time to response (TTR)
Time frame: 24 months
Progression free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 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 24 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
7 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 IBI129 in people with Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 7 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 6 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Australia. 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 subjects with adverse events (time frame: 24 months). The study lists 4 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 24 Jun 2026.