Small Cell Lung Cancer (SCLC)
Conditions
Brief summary
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
Interventions
DRUGIBI115
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.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
： 1. Participants must be able to understand and sign the written informed consent form for participation in this trial, including all evaluations and procedures specified in this protocol. 2. Male or female participants aged ≥18 years and ≤75 years. 3. Participants with histologically or cytologically confirmed advanced small cell lung cancer. 4. At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI115. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 6. Expected survival period ≥12 weeks. 7. Adequate bone marrow and organ function confirmed during the screening period.
Exclusion criteria
： 1. Concurrent participation in another interventional clinical study, except for observational non-interventional studies or being in the survival follow-up phase of an interventional study. 2. Administration of a live vaccine within 4 weeks prior to the first dose of the study drug or a cancer vaccine within 3 months prior, or planning to receive any live vaccine during the study period. 3. Adverse reactions from prior anti-tumor therapy that have not resolved to CTCAE v6.0 Grade 0, Grade 1, or baseline levels by the time of the first dose of the study drug. 4. Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE) | up to 90 days after the last administration | Safety Features including Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE). |
| Dose-limiting toxicity (DLT) | up to 28 days after the first dose of IBI115 | DLTs will be assessed during the DLT observation period to determine maximum tolerated dose (MTD) ) and/or recommended dose for combination (RDC). |
| MTD of IBI115 | up to 90 days after the last administration | to determine MTD of IBI115 |
| RDC of IBI115 | up to 90 days after the last administration | to determine RDC of IBI115 |
| Number of participants with clinically significant changes in physical examination results | up to 90 days after the last administration | 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. |
| Number of participants with abnormal vital signs | up to 90 days after the last administration | Collection of vital signs will include body temperature, heart rate, respiratory rate, blood pressure, and oxygen saturation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration-time curve (AUC) | Up to 7 days after the last administration | an element to assess the pharmacokinetics (PK) profile of IBI115 |
| Peak plasma concentration | Up to 7 days after the last administration | an element to assess the PK profile of IBI115 |
| Time to peak concentration | Up to 7 days after the last administration | an element to assess the PK profile of IBI115 |
| Clearance (CL) | Up to 7 days after the last administration | an element to assess the PK profile of IBI115 |
| Apparent volume of distribution (V) | Up to 7 days after the last administration | an element to assess the PK profile of IBI115 |
| Half-life (T1/2) | Up to 7 days after the last administration | an element to assess the PK profile of IBI115 |
| Incidence of anti-drug antibodies (ADA) | Up to 7 days after the last administration | an element to assess the immunogenicity profile of IBI115 |
| Incidence of neutralizing antibodies (NAb) (if applicable) | Up to 7 days after the last administration | an element to assess the immunogenicity profile of IBI115 |
| Objective response rate (ORR) | Through study completion, up to 2 years | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Duration of response (DoR) | Through study completion, up to 2 years | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Tisease control rate (DCR) | Through study completion, up to 2 years | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Time to response (TTR) | Through study completion, up to 2 years | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Progression-free survival (PFS) | Through study completion, up to 2 years | based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Overall survival (OS) | Through study completion, up to 2 years | Overall survival (OS) |
Countries
China
Contacts
CONTACTXiao Zhang
Outcome results
None listed