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NCT Number: NCT07559019

Safety and Preliminary Activity of BI115 in Advanced SCLC

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

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Key information

Conditions

Small Cell Lung Cancer (SCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

the second affiliated hospital of AMU

Chongqing, Chongqing Municipality, 400037, China

Location status: Recruiting

Location contact

Bo Zhu

CONTACT

[email protected]

+86 023 6875 5114

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    Safety Features including Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE).

  2. Dose-limiting toxicity (DLT)

    Time frame: 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).

  3. MTD of IBI115

    Time frame: up to 90 days after the last administration

    to determine MTD of IBI115

  4. RDC of IBI115

    Time frame: up to 90 days after the last administration

    to determine RDC of IBI115

  5. Number of participants with clinically significant changes in physical examination results

    Time frame: 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.

  6. Number of participants with abnormal vital signs

    Time frame: 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 outcomes

  1. Area under the concentration-time curve (AUC)

    Time frame: Up to 7 days after the last administration

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

  2. Peak plasma concentration

    Time frame: Up to 7 days after the last administration

    an element to assess the PK profile of IBI115

  3. Time to peak concentration

    Time frame: Up to 7 days after the last administration

    an element to assess the PK profile of IBI115

  4. Clearance (CL)

    Time frame: Up to 7 days after the last administration

    an element to assess the PK profile of IBI115

  5. Apparent volume of distribution (V)

    Time frame: Up to 7 days after the last administration

    an element to assess the PK profile of IBI115

  6. Half-life (T1/2)

    Time frame: Up to 7 days after the last administration

    an element to assess the PK profile of IBI115

  7. Incidence of anti-drug antibodies (ADA)

    Time frame: Up to 7 days after the last administration

    an element to assess the immunogenicity profile of IBI115

  8. Incidence of neutralizing antibodies (NAb) (if applicable)

    Time frame: Up to 7 days after the last administration

    an element to assess the immunogenicity profile of IBI115

  9. Objective response rate (ORR)

    Time frame: Through study completion, up to 2 years

    based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  10. Duration of response (DoR)

    Time frame: Through study completion, up to 2 years

    based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  11. Tisease control rate (DCR)

    Time frame: Through study completion, up to 2 years

    based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  12. Time to response (TTR)

    Time frame: Through study completion, up to 2 years

    based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  13. Progression-free survival (PFS)

    Time frame: Through study completion, up to 2 years

    based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  14. Overall survival (OS)

    Time frame: Through study completion, up to 2 years

    Overall survival (OS)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Zhang

CONTACT

[email protected]

+86 021 3183 7200

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Apr 30, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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