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Recruiting NCT07559019

Safety and Preliminary Activity of BI115 in Advanced SCLC

Phase I Interventional Small Cell Lung Cancer (SCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI115.
Who it may be relevant to
Registry conditions: Small Cell Lung Cancer (SCLC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants With Advanced Small Cell Lung Cancer

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

Interventions

  • Drug IBI115
    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.

Primary outcome measures

  • Number of participants with 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) [Time frame: up to 28 days after the first dose of IBI115]
  • MTD of IBI115 [Time frame: up to 90 days after the last administration]
  • RDC of IBI115 [Time frame: up to 90 days after the last administration]
  • Number of participants with clinically significant changes in physical examination results [Time frame: up to 90 days after the last administration]
  • Number of participants with abnormal vital signs [Time frame: up to 90 days after the last administration]
Secondary outcome measures (12)
  • Area under the concentration-time curve (AUC) [Time frame: Up to 7 days after the last administration]
  • Peak plasma concentration [Time frame: Up to 7 days after the last administration]
  • Time to peak concentration [Time frame: Up to 7 days after the last administration]
  • Clearance (CL) [Time frame: Up to 7 days after the last administration]
  • Apparent volume of distribution (V) [Time frame: Up to 7 days after the last administration]
  • Half-life (T1/2) [Time frame: Up to 7 days after the last administration]
  • Incidence of anti-drug antibodies (ADA) [Time frame: Up to 7 days after the last administration]
  • Incidence of neutralizing antibodies (NAb) (if applicable) [Time frame: Up to 7 days after the last administration]
  • Objective response rate (ORR) [Time frame: Through study completion, up to 2 years]
  • Duration of response (DoR) [Time frame: Through study completion, up to 2 years]
  • Tisease control rate (DCR) [Time frame: Through study completion, up to 2 years]
  • Time to response (TTR) [Time frame: Through study completion, up to 2 years]

Eligibility criteria

Inclusion Criteria：

  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Expected survival period ≥12 weeks.
  • Adequate bone marrow and organ function confirmed during the screening period.

Exclusion Criteria：

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the second affiliated hospital of AMU — Chongqing

Identifiers

NCT: NCT07559019 · CIBI115A101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗