Solid TumorsPhase 1NCT07902804
A Study of IBI3043 Treatment in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors
A Phase 1 study testing IBI3043 in people with Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3043 in participants with unresectable,locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- IBI3043
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2026to 31 Dec 2028
- Phase
- Phase 1
- 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
- 1. Participants must have the ability to understand and sign a written informed consent form for participation in this study, including all assessments and procedures specified in the protocol;
- 2. Male or female participants aged ≥18 years;
- 3. At least one measurable lesion as defined by RECIST v1.1 within 28 days prior to the first dose of IBI3043;
- 4. ECOG performance status of 0-1;
- 5. Life expectancy of at least 12 weeks at the start of treatment;
- 6. Adequate bone marrow and organ function as confirmed during the screening period;
Show all 9Show fewer
- 7. Male or female participants who are either of non-reproductive potential or agree to use at least one highly effective method of contraception during the study period (starting from screening or 2 weeks prior to first dosing, whichever comes first, and continuing until 6 months after the last dose of study drug);
- 8. Not amenable to curative surgical resection or definitive chemoradiotherapy;
- 9. Participants with locally advanced, unresectable, or metastatic solid tumors who have failed or are intolerant to standard therapy.
Who cannot join
- 1. Participation in any interventional clinical study other than observational (non-interventional) studies, or currently in the up period of an interventional study;
- 2. Adverse reactions from prior anti-tumor therapies that have not resolved to Grade 0 or 1, or baseline levels, according to NCI CTCAE v6.0, prior to the first dose of study drug (exceptions include alopecia, fatigue, hyperpigmentation, or other conditions deemed without safety risk by the investigator);
- 3. Known symptomatic central nervous system (CNS) metastases. Participants with asymptomatic CNS metastases (i.e., no neurological syndrome and metastatic lesion diameter ≤1.5 cm) or those with stable disease post-treatment as judged by the investigator may be considered under the following conditions: absence of midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord involvement; clinically stable for at least 4 weeks prior to the first dose of study drug (stable on ≤1.5 mg/day dexamethasone or equivalent corticosteroid and baseline anticonvulsant therapy), with no clinically confirmed new or enlarging CNS lesions.
- 4. Patients with imaging results during the screening period suggesting that the tumor surrounds important blood vessels, or there is obvious necrosis or cavity, and the investigator judges that there is a risk of bleeding;
- 5. Tumor invasion into surrounding critical organs or structures (e.g., cardiac pericardium, mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula formation;
- 6. Received major surgery (e.g., craniotomy, thoracotomy, or laparotomy, or other surgeries as determined by the investigator) within 4 weeks prior to the first dose of study drug, excluding core biopsy; or anticipated to undergo major surgery during the study period; or presence of serious non-healing wounds, trauma, ulcers, etc.
- 7. Known hypersensitivity, allergic reaction, or intolerance to IBI3043 or its excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou, 510060
Li Zhang, 020-87342288, zhangli@sysucc.org.cn
About this study
Official title: A Phase 1, Multicenter, Open-label Study of IBI3043 Treatment in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors
This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3043 in participants with unresectable,locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Safety will be monitored by the Safety Review Committee (SRC).
- Conditions
- Solid Tumors
- Being tested
- IBI3043
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3043Drug
IBI3043 is an investigational drug administered as Q2W or Q3W according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| IBI3043 | Experimental | Not described Receives: Drug: IBI3043 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (part 1)
Measured: up to 2 years
ORR (part 2)
Measured: up to 2 years
Serious Adverse Event
Measured: up to 2 years
Maximum Tolerated Dose (part 1)
Measured: up to 2 years
DLT(Dose-limiting Toxicity) (part 1)
Measured: up to 2 years
Secondary outcomes (8)
PK concentration：IBI3043 serum concentration
Measured: up to 2 years
ADA (Anti-drug antibody)
Measured: up to 2 years
Nab (Neutralizing antibody)
Measured: up to 2 years
ORR (Objective Response Rate) (part 1)
Measured: up to 2 years
DoR (Duration of Response)
Measured: up to 2 years
TTR (Time to Response)
Measured: up to 2 years
PFS (Progression-free Survival)
Measured: up to 2 years
OS (Overall Survival)
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 posted29 Oct 2026
- Study start16 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 604 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
- NCT07902804
- Sponsor's protocol ID
- CIBI3043A101
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label Study of IBI3043 Treatment in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07902804
- Acronym / sponsor ID
- CIBI3043A101
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 604 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Oct 2026 (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 multicenter, open-label, phase I dose-escalation and expansion study of IBI3043 in participants with unresectable,locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Safety will be monitored by the Safety Review Committee (SRC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI3043 | Experimental | Drug: IBI3043 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Participants must have the ability to understand and sign a written informed consent form for participation in this study, including all assessments and procedures specified in the protocol;
- 2. Male or female participants aged ≥18 years;
- 3. At least one measurable lesion as defined by RECIST v1.1 within 28 days prior to the first dose of IBI3043;
- 4. ECOG performance status of 0-1;
- 5. Life expectancy of at least 12 weeks at the start of treatment;
Key exclusion criteria (7 listed)
- 1. Participation in any interventional clinical study other than observational (non-interventional) studies, or currently in the up period of an interventional study;
- 2. Adverse reactions from prior anti-tumor therapies that have not resolved to Grade 0 or 1, or baseline levels, according to NCI CTCAE v6.0, prior to the first dose of study drug (exceptions include alopecia, fatigue, hyperpigmentation, or other conditions deemed without safety risk by the investigator);
- 3. Known symptomatic central nervous system (CNS) metastases. Participants with asymptomatic CNS metastases (i.e., no neurological syndrome and metastatic lesion diameter ≤1.5 cm) or those with stable disease post-treatment as judged by the investigator may be considered under the following conditions: absence of midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord involvement; clinically stable for at least 4 weeks prior to the first dose of study drug (stable on ≤1.5 mg/day dexamethasone or equivalent corticosteroid and baseline anticonvulsant therapy), with no clinically confirmed new or enlarging CNS lesions.
- 4. Patients with imaging results during the screening period suggesting that the tumor surrounds important blood vessels, or there is obvious necrosis or cavity, and the investigator judges that there is a risk of bleeding;
- 5. Tumor invasion into surrounding critical organs or structures (e.g., cardiac pericardium, mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula formation;
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 |
|---|---|---|
| IBI3043IBI3043 is an investigational drug administered as Q2W or Q3W according to the study protocol. | Drug | IBI3043 |
Primary outcome
Adverse Event (part 1)
Time frame: up to 2 years
ORR (part 2)
Time frame: up to 2 years
Serious Adverse Event
Time frame: up to 2 years
Maximum Tolerated Dose (part 1)
Time frame: up to 2 years
DLT(Dose-limiting Toxicity) (part 1)
Time frame: up to 2 years
8 secondary outcomes
PK concentration：IBI3043 serum concentration
Time frame: up to 2 years
ADA (Anti-drug antibody)
Time frame: up to 2 years
Nab (Neutralizing antibody)
Time frame: up to 2 years
ORR (Objective Response Rate) (part 1)
Time frame: up to 2 years
DoR (Duration of Response)
Time frame: up to 2 years
TTR (Time to Response)
Time frame: up to 2 years
PFS (Progression-free Survival)
Time frame: up to 2 years
OS (Overall Survival)
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 29 Oct 2026.
Related trials for Solid Tumors
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.
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 IBI3043 in people with 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 7 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: opening soon, as of the sponsor's last update on 29 Oct 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 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?
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 Xiuzhi Yu (0512-69566088, xiuzhi.yu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (part 1) (time frame: up to 2 years). The study lists 5 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 29 Oct 2026.