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This study is a multi-regional, open-label phase I study to evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants with Advanced Small Cell Lung Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI115 | Experimental | Subjects will receive IBI115 therapy until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of treatment with IBI115 is 24M. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI115 | Drug | IBI115 will be administered. The Dose Limiting Toxicity (DLT) observation period will last for 28 or 21 days after first dose. After completion of the DLT observation period, subject will continue to receive IBI115 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal od consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE) | Safety Features including Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE). | up to 90 days after the last administration |
| Dose-limiting toxicity (DLT) | DLTs will be assessed during the DLT observation period to determine maximum tolerated dose (MTD) ) and/or recommended dose for combination (RDC). | up to 28 days after the first dose of IBI115 |
| MTD of IBI115 | to determine MTD of IBI115 | up to 90 days after the last administration |
| RDC of IBI115 | to determine RDC of IBI115 | up to 90 days after the last administration |
| Number of participants with clinically significant changes in physical examination results | A complete physical examination will include: general appearance, respiratory, cardiovascular, abdomen, skin, head and neck (including ears, eyes, nose, and pharynx), lymph nodes, thyroid, musculoskeletal (including spine and extremities), genital/anal, and neurological assessments, if indicated. Clinically significant abnormal findings at screening will be recorded as medical history or AE based on the investigator's analysis and judgment. | up to 90 days after the last administration |
| Number of participants with abnormal vital signs | Collection of vital signs will include body temperature, heart rate, respiratory rate, blood pressure, and oxygen saturation. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) | an element to assess the pharmacokinetics (PK) profile of IBI115 | Up to 7 days after the last administration |
| Peak plasma concentration | an element to assess the PK profile of IBI115 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Zhang | Contact | +86 021 3183 7200 | kobe.zhang@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the second affiliated hospital of AMU | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| up to 90 days after the last administration |
| Up to 7 days after the last administration |
| Time to peak concentration | an element to assess the PK profile of IBI115 | Up to 7 days after the last administration |
| Clearance (CL) | an element to assess the PK profile of IBI115 | Up to 7 days after the last administration |
| Apparent volume of distribution (V) | an element to assess the PK profile of IBI115 | Up to 7 days after the last administration |
| Half-life (T1/2) | an element to assess the PK profile of IBI115 | Up to 7 days after the last administration |
| Incidence of anti-drug antibodies (ADA) | an element to assess the immunogenicity profile of IBI115 | Up to 7 days after the last administration |
| Incidence of neutralizing antibodies (NAb) (if applicable) | an element to assess the immunogenicity profile of IBI115 | Up to 7 days after the last administration |
| Objective response rate (ORR) | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Through study completion, up to 2 years |
| Duration of response (DoR) | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Through study completion, up to 2 years |
| Tisease control rate (DCR) | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Through study completion, up to 2 years |
| Time to response (TTR) | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Through study completion, up to 2 years |
| Progression-free survival (PFS) | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Through study completion, up to 2 years |
| Overall survival (OS) | Overall survival (OS) | Through study completion, up to 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |