Safety and Preliminary Activity of BI115 in Advanced SCLC
ConditionSmall Cell Lung Cancer (SCLC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Male or female participants aged ≥18 years and ≤75 years.
Participants with histologically or cytologically confirmed advanced small cell lung cancer.
At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI115.
Disqualifiers
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.
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.
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.
Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.
Trial design
Design model
Single group
Treatments tested in this trial
IBI115
DrugIBI115 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: IBI115Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
up to 90 days after the last administration2
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).
Time frame
up to 28 days after the first dose of IBI1153
MTD of IBI115
to determine MTD of IBI115
Time frame
up to 90 days after the last administration4
RDC of IBI115
to determine RDC of IBI115
Time frame
up to 90 days after the last administrationSecondary outcomes
1
Area under the concentration-time curve (AUC)
an element to assess the pharmacokinetics (PK) profile of IBI115
Time frame
Up to 7 days after the last administration2
Peak plasma concentration
an element to assess the PK profile of IBI115
Time frame
Up to 7 days after the last administration3
Time to peak concentration
an element to assess the PK profile of IBI115
Time frame
Up to 7 days after the last administration4
Clearance (CL)
an element to assess the PK profile of IBI115
Time frame
Up to 7 days after the last administrationSponsors and contacts
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Source ClinicalTrials.gov