Safety and Preliminary Activity of BI115 in Advanced SCLC

Phase 1RecruitingNCT07559019

Innovent Biologics (Suzhou) Co. Ltd.150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Small Cell Lung Cancer (SCLC)

Interventions

IBI115DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

the second affiliated hospital of AMU

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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 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).

Time frame: up to 28 days after the first dose of IBI115

MTD of IBI115

to determine MTD of IBI115

Time frame: up to 90 days after the last administration

RDC of IBI115

to determine RDC of IBI115

Time frame: 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.

Time frame: 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.

Time frame: up to 90 days after the last administration

Secondary Outcomes

Central Contacts

Xiao Zhang

CONTACT

+86 021 3183 7200 kobe.zhang@innoventbio.com

Data from ClinicalTrials.gov

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Area under the concentration-time curve (AUC)

an element to assess the pharmacokinetics (PK) profile of IBI115