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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1:IBI3005+Sintilimab+ Carboplatin+IBI305 | Experimental |
| |
| Cohort 2:IBI3005+Sintilimab+ Carboplatin | Experimental |
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| Cohort 3:IBI3005+Limertinib/Osimertinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3005 | Drug | Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D code: IBI3005) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | Up to 3 years |
| Dose limiting toxicities (DLTs) | Dose limiting toxicities (DLTs) to establish MTD and/or RP2D. | 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. | Up to 3 years |
| Number of subjects with clinically significant changes in physical examination results |
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve (AUC) | area under the curve (AUC) of single and multiple doses of IBI3005 | Up to 3 years |
| maximum concentration (Cmax) | maximum concentration (Cmax) of single and multiple doses of IBI3005 |
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Inclusion Criteria:
Additional Inclusion Criteria for Cohort 1:
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
Exclusion Criteria:
Additional Exclusion Criteria for Cohort 1:
Additional Exclusion Criteria for Cohort 2:
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."
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Luo | Contact | +86 21 3183 7200 | yang.luo@innoventbio.com | |
| Yulong Zhang | Contact | +86 21 3183 7200 | yulong.zhang@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SunYat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| Sintilimab | Drug | Anti-PD-1 Monoclonal Antibody |
|
| Bevacizumab biosimilar | Drug | Recombinant humanized anti-VEGF monoclonal antibody |
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| Limertinib | Drug | Third-generation EGFR-TKI |
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| Osimertinib | Drug | Third-generation EGFR-TKI |
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| Carboplatin | Drug | Second-generation platinum-based chemotherapy drugs |
|
Clinically significant abnormal physical examination findings reported by the investigator. |
| 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 | Up to 3 years |
| Objective Response Rate, (ORR) | as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| duration of response (DCR) | as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| time to response (TTR) | as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| duration of response (DoR) | as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| progression free survival (PFS) | as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| overall survival (OS) | Up to 3 years |
| Up to 3 years |
| time to maximum concentration (Tmax) | time to maximum concentration (Tmax) of single and multiple doses of IBI3005 | Up to 3 years |
| clearance (CL) | clearance (CL) of single and multiple doses of IBI3005 | Up to 3 years |
| apparent volume of distribution (V) | apparent volume of distribution (V) of single and multiple doses of IBI3005 | Up to 3 years |
| half-life (t1/2) | half-life (t1/2) of IBI3005 to the last administration of IBI3005 | Up to 3 years |
| anti-drug antibody (ADA) | Incidence and characterization of anti-drug antibody (ADA). | Up to 3 years |
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C000596361 | osimertinib |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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