Safety and Preliminary Activity of BI115 in Advanced SCLC

NCT07559019 | Not Yet Recruiting Phase 1

• 1 other identifier: CIBI115A101
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Small Cell Lung Cancer (SCLC)

Outcome Measures

Primary Outcomes (6)

• 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.

  up to 90 days after the last administration

Secondary Outcomes (14)

• Area under the concentration-time curve (AUC)

  Up to 7 days after the last administration

• Peak plasma concentration

  Up to 7 days after the last administration

• Time to peak concentration

  Up to 7 days after the last administration

• Clearance (CL)

  Up to 7 days after the last administration

• Apparent volume of distribution (V)

  Up to 7 days after the last administration

Study Arms (1)

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.

Drug: IBI115

Interventions

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.

IBI115

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

the second affiliated hospital of AMU

Chongqing, Chongqing Municipality, 400037, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Chunxian Hu

CONTACT

+86 021 3183 7200; chunxian.hu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): March 30, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (1)