Solid TumorPhase 1/2NCT07612137
Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing IBI3005, Sintilimab and Bevacizumab biosimilar in people with Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy 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
- Solid Tumor
- What is being tested?
- IBI3005, Sintilimab and Bevacizumab biosimilar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 30 Jun 2028
- 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
- Has signed a written informed consent form (ICF) and is able to comply with the scheduled study visits and related procedures.
- Age ≥ 18 years, irrespective of gender.
- Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor.
- Expected survival ≥ 12 weeks.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
- Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to the first study drug administration.
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- Adequate bone marrow and organ function.
- Additional Inclusion Criteria for Cohort 1:
- Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.
- Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens.
- In the safety run-in phase, NSCLC participants who have received prior standard therapy.
- In the cohort expansion phase, participants without driver gene mutations who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease.
- Additional Inclusion Criteria for Cohort 2:
- Histologically or cytologically confirmed unresectable locally advanced or metastatic non-squamous NSCLC.
- In the safety run-in phase, participants should have received prior standard therapy.
- In the cohort expansion phase:
- Cohort 2A: NSCLC participants without driver gene mutations (including at least EGFR, ALK, and ROS1, with written documentation) who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease. Participants who received neoadjuvant/adjuvant therapy are eligible if disease recurrence or progression occurred >6 months after the last neoadjuvant/adjuvant therapy.
- Cohort 2B: NSCLC participants with tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens, who have experienced disease progression after prior EGFR-TKI therapy.
- Additional Inclusion Criteria for Cohort 3
- Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.
- Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens.
- In the safety run-in phase, participants should have experienced disease progression after prior EGFR-TKI therapy.
- In the cohort expansion phase, NSCLC participants who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease. Participants who received neoadjuvant/adjuvant therapy are eligible if disease recurrence or progression occurred >6 months after the last neoadjuvant/adjuvant therapy.
Who cannot join
- Participation in any other interventional clinical study, except for observational (non-interventional) studies or the follow-up period after the end of study treatment in an interventional study.
- Prior treatment with antibody-drug conjugate (ADC) drugs bearing a camptothecin or its derivative (topoisomerase I inhibitor) small-molecule payload.
- Prior to the first dose of study drug: a) Within 4 weeks: Received intravenous chemotherapy, macromolecular targeted therapy, antibody-drug conjugates, immunotherapy, endocrine therapy, cell therapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy. b) Within 2 weeks or 5 half-lives (whichever is shorter): Received oral chemotherapy, small-molecule targeted therapy, or traditional Chinese herbal medicines indicated for anti-tumor treatment. c) Within 4 weeks: Received radical radiotherapy; within 2 weeks: Received palliative radiotherapy. d) Within 2 weeks or 5 half-lives (whichever is shorter): Received strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4). e) Within 4 weeks: Underwent major surgery (craniotomy, thoracotomy, laparotomy, or other surgeries deemed ""major"" by the investigator, excluding puncture biopsy), or has severe unhealed wounds, trauma, or ulcers; within 2 weeks: Underwent laparoscopic exploratory surgery. f) Within 4 weeks: Received live vaccine (mRNA and non-replicating adenovirus vaccines are not considered live vaccines).
- Presence of adverse events from prior anti-tumor therapy that have not resolved to Grade 0 or 1 per NCI-CTCAE v5.0 [excluding Grade 2 alopecia, fatigue, pigmentation, insomnia, peripheral neuropathy, hypomagnesemia, and toxicities stably controlled by medication (e.g., hypothyroidism stably controlled by replacement therapy, hypertension with blood pressure stably controlled below 160/100 mmHg by antihypertensive medication)].
- Additional Exclusion Criteria for Cohort 1:
- History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.
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- History of significant toxicity associated with immune checkpoint inhibitor administration that required permanent discontinuation of such therapy.
- Additional Exclusion Criteria for Cohort 2:
- History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.
- History of significant toxicity associated with immune checkpoint inhibitor administration that required permanent discontinuation of such therapy.
- History of hemoptysis within 3 months prior to the first dose (blood volume >2.5 mL per cough or cumulative daily hemoptysis >10 mL), or current active bleeding.
- Continuous use of aspirin (>325 mg/day) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function within 2 weeks prior to the first dose."
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
SunYat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, 020-87343458, zhangli@sysucc.org.cn
Wenfeng Fang, 020-87343458, fangwenfeng@sysucc.org.cn
About this study
Official title: A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBI3005 Combination Therapy in Participants With Advanced Solid Tumors
To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- IBI3005, Sintilimab, Bevacizumab biosimilar, Limertinib, Osimertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3005Drug
Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)
SintilimabDrug
Anti-PD-1 Monoclonal Antibody
Bevacizumab biosimilarDrug
Recombinant humanized anti-VEGF monoclonal antibody
LimertinibDrug
Third-generation EGFR-TKI
OsimertinibDrug
Third-generation EGFR-TKI
CarboplatinDrug
Second-generation platinum-based chemotherapy drugs
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305 | Experimental | Not described Receives: Drug: IBI3005; Drug: Sintilimab; Drug: Bevacizumab biosimilar; Drug: Carboplatin |
| Cohort 2：IBI3005+Sintilimab+ Carboplatin | Experimental | Not described Receives: Drug: IBI3005; Drug: Sintilimab; Drug: Carboplatin |
| Cohort 3：IBI3005+Limertinib/Osimertinib | Experimental | Not described Receives: Drug: IBI3005; Drug: Limertinib; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Measured: Up to 3 years
Number of subjects with treatment emergent adverse events
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Measured: Up to 3 weeks
Number of subjects with adverse events of special interest
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Measured: Up to 3 years
Number of subjects with serious adverse events
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Measured: Up to 3 years
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
Measured: Up to 3 weeks
Number of subjects with clinically significant changes in laboratory tests results
Clinically significant abnormal laboratory tests results reported by the investigator.
Measured: Up to 3 years
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Measured: Up to 3 years
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Measured: Up to 3 years
Objective Response Rate, (ORR）
as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
duration of response (DCR)
as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
time to response (TTR)
as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
duration of response (DoR)
as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
progression free survival (PFS)
as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
overall survival (OS)
Measured: Up to 3 years
Secondary outcomes (7)
area under the curve (AUC)
area under the curve (AUC) of single and multiple doses of IBI3005
Measured: Up to 3 years
maximum concentration (Cmax)
maximum concentration (Cmax) of single and multiple doses of IBI3005
Measured: Up to 3 years
time to maximum concentration (Tmax)
time to maximum concentration (Tmax) of single and multiple doses of IBI3005
Measured: Up to 3 years
clearance (CL)
clearance (CL) of single and multiple doses of IBI3005
Measured: Up to 3 years
apparent volume of distribution (V)
apparent volume of distribution (V) of single and multiple doses of IBI3005
Measured: Up to 3 years
half-life (t1/2)
half-life (t1/2) of IBI3005 to the last administration of IBI3005
Measured: Up to 3 years
anti-drug antibody (ADA)
Incidence and characterization of anti-drug antibody (ADA).
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 282 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
- NCT07612137
- Sponsor's protocol ID
- CIBI3005A102
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBI3005 Combination Therapy in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07612137
- Acronym / sponsor ID
- CIBI3005A102
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 May 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.
To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305 | Experimental | Drug: IBI3005, Drug: Sintilimab, Drug: Bevacizumab biosimilar, Drug: Carboplatin |
| Cohort 2：IBI3005+Sintilimab+ Carboplatin | Experimental | Drug: IBI3005, Drug: Sintilimab, Drug: Carboplatin |
| Cohort 3：IBI3005+Limertinib/Osimertinib | Experimental | Drug: IBI3005, Drug: Limertinib, Drug: Osimertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Has signed a written informed consent form (ICF) and is able to comply with the scheduled study visits and related procedures.
- Age ≥ 18 years, irrespective of gender.
- Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor.
- Expected survival ≥ 12 weeks.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
Key exclusion criteria (12 listed)
- Participation in any other interventional clinical study, except for observational (non-interventional) studies or the follow-up period after the end of study treatment in an interventional study.
- Prior treatment with antibody-drug conjugate (ADC) drugs bearing a camptothecin or its derivative (topoisomerase I inhibitor) small-molecule payload.
- Prior to the first dose of study drug: a) Within 4 weeks: Received intravenous chemotherapy, macromolecular targeted therapy, antibody-drug conjugates, immunotherapy, endocrine therapy, cell therapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy. b) Within 2 weeks or 5 half-lives (whichever is shorter): Received oral chemotherapy, small-molecule targeted therapy, or traditional Chinese herbal medicines indicated for anti-tumor treatment. c) Within 4 weeks: Received radical radiotherapy; within 2 weeks: Received palliative radiotherapy. d) Within 2 weeks or 5 half-lives (whichever is shorter): Received strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4). e) Within 4 weeks: Underwent major surgery (craniotomy, thoracotomy, laparotomy, or other surgeries deemed ""major"" by the investigator, excluding puncture biopsy), or has severe unhealed wounds, trauma, or ulcers; within 2 weeks: Underwent laparoscopic exploratory surgery. f) Within 4 weeks: Received live vaccine (mRNA and non-replicating adenovirus vaccines are not considered live vaccines).
- Presence of adverse events from prior anti-tumor therapy that have not resolved to Grade 0 or 1 per NCI-CTCAE v5.0 [excluding Grade 2 alopecia, fatigue, pigmentation, insomnia, peripheral neuropathy, hypomagnesemia, and toxicities stably controlled by medication (e.g., hypothyroidism stably controlled by replacement therapy, hypertension with blood pressure stably controlled below 160/100 mmHg by antihypertensive medication)].
- History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic 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 |
|---|---|---|
| IBI3005Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005) | Drug | Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305, Cohort 2：IBI3005+Sintilimab+ Carboplatin, Cohort 3：IBI3005+Limertinib/Osimertinib |
| SintilimabAnti-PD-1 Monoclonal Antibody | Drug | Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305, Cohort 2：IBI3005+Sintilimab+ Carboplatin |
| Bevacizumab biosimilarRecombinant humanized anti-VEGF monoclonal antibody | Drug | Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305 |
| LimertinibThird-generation EGFR-TKI | Drug | Cohort 3：IBI3005+Limertinib/Osimertinib |
| OsimertinibThird-generation EGFR-TKI | Drug | Cohort 3：IBI3005+Limertinib/Osimertinib |
| CarboplatinSecond-generation platinum-based chemotherapy drugs | Drug | Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305, Cohort 2：IBI3005+Sintilimab+ Carboplatin |
Primary outcome
Number of subjects with adverse events
Time frame: Up to 3 years
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with treatment emergent adverse events
Time frame: Up to 3 weeks
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with adverse events of special interest
Time frame: Up to 3 years
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with serious adverse events
Time frame: Up to 3 years
defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Dose limiting toxicities (DLTs)
Time frame: Up to 3 weeks
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
Number of subjects with clinically significant changes in laboratory tests results
Time frame: Up to 3 years
Clinically significant abnormal laboratory tests results reported by the investigator.
Number of subjects with clinically significant changes in physical examination results
Time frame: Up to 3 years
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
Time frame: Up to 3 years
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Objective Response Rate, (ORR）
Time frame: Up to 3 years
as evaluated per the RECIST v1.1 criteria.
duration of response (DCR)
Time frame: Up to 3 years
as evaluated per the RECIST v1.1 criteria.
time to response (TTR)
Time frame: Up to 3 years
as evaluated per the RECIST v1.1 criteria.
duration of response (DoR)
Time frame: Up to 3 years
as evaluated per the RECIST v1.1 criteria.
progression free survival (PFS)
Time frame: Up to 3 years
as evaluated per the RECIST v1.1 criteria.
overall survival (OS)
Time frame: Up to 3 years
7 secondary outcomes
area under the curve (AUC)
Time frame: Up to 3 years
maximum concentration (Cmax)
Time frame: Up to 3 years
time to maximum concentration (Tmax)
Time frame: Up to 3 years
clearance (CL)
Time frame: Up to 3 years
apparent volume of distribution (V)
Time frame: Up to 3 years
half-life (t1/2)
Time frame: Up to 3 years
anti-drug antibody (ADA)
Time frame: Up to 3 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 28 May 2026.
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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.
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 IBI3005, Sintilimab and Bevacizumab biosimilar in people with Solid Tumor, 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 23 inclusion and 12 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 28 May 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?
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 Yang Luo (+86 21 3183 7200, yang.luo@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 adverse events (time frame: Up to 3 years). The study lists 14 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 28 May 2026.