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IBI188 Combination Therapy in Solid Tumors

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ClinicalTrials.gov Identifier: NCT04861948
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Tracking Information
First Submitted Date  ICMJE April 22, 2021
First Posted Date  ICMJE April 27, 2021
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE May 25, 2021
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2021)
  • Objective Response Rate [ Time Frame: 24 months ]
  • Adverse Events [ Time Frame: 24 months ]
    Incidence, correlation with the study drug and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2021)
  • Progression-free survival [ Time Frame: 24 months ]
  • Overall survival [ Time Frame: 24 months ]
  • Disease control rate [ Time Frame: 24 months ]
  • Duration of response [ Time Frame: 24 months ]
  • Time to response [ Time Frame: 24 months ]
  • Area Under Curve, AUC [ Time Frame: 24 months ]
  • maximum concentration (Cmax) [ Time Frame: 24 months ]
  • minimum concentration (Cmin) [ Time Frame: 24 months ]
  • clearance (CL) [ Time Frame: 24 months ]
  • volume of distribution (V) [ Time Frame: 24 months ]
  • half-life (t1/2) [ Time Frame: 24 months ]
  • Positive rate of anti-drug antibody (ADA) [ Time Frame: 24 months ]
  • Positive rate of neutralizing antibody (NAb) [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2021)
  • Progression-free survival [ Time Frame: 24 months ]
  • Overall survival [ Time Frame: 24 months ]
  • Disease control rate [ Time Frame: 24 months ]
  • Duration of response [ Time Frame: 24 months ]
  • Time to response [ Time Frame: 24 months ]
  • Area Under Curve, AUC [ Time Frame: 24 months ]
  • maximum concentration (Cmax) [ Time Frame: 24 months ]
  • minimum concentration (Cmin) [ Time Frame: 24 months ]
  • clearance (CL), volume of distribution (V) and half-life (t1/2) [ Time Frame: 24 months ]
  • volume of distribution (V) [ Time Frame: 24 months ]
  • half-life (t1/2) [ Time Frame: 24 months ]
  • Positive rate of anti-drug antibody (ADA) [ Time Frame: 24 months ]
  • Positive rate of neutralizing antibody (NAb) [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IBI188 Combination Therapy in Solid Tumors
Official Title  ICMJE Phase Ib Study to Evaluate the Efficacy, Safety and Tolerability of IBI188 Combination Therapy in Subjects With Advanced Malignancies
Brief Summary A Phase Ib study aim to explore the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • Lung Adenocarcinoma
  • Osteosarcoma
Intervention  ICMJE
  • Drug: IBI188
    intravenous
  • Drug: GM-CSF
    subcutaneous injection
  • Drug: Cisplatin/Carboplatin
    intravenous
  • Drug: Bevacizumab
    intravenous
  • Drug: Sintilimab
    intravenous
  • Drug: Pemetrexed
    intravenous
Study Arms  ICMJE
  • Experimental: Cohort A
    Interventions:
    • Drug: IBI188
    • Drug: Sintilimab
  • Experimental: Cohort B
    Interventions:
    • Drug: IBI188
    • Drug: Cisplatin/Carboplatin
    • Drug: Bevacizumab
    • Drug: Pemetrexed
  • Experimental: Cohort C
    Interventions:
    • Drug: IBI188
    • Drug: GM-CSF
  • Experimental: Cohort D
    Interventions:
    • Drug: IBI188
    • Drug: Sintilimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2021)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .
  2. Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).
  3. Able to provide archived or fresh tumor tissue samples for biomarker assessment.
  4. Have at least one measurable lesion according to RECIST version 1.1.
  5. ECCG PS score of 0-2.
  6. Adequate organ and bone marrow functions .
  7. Life expectancy ≥ 12 weeks.
  8. Female subjects of childbearing potential or male subjects with partners of childbearing potential should take effective contraceptive measures throughout the whole treatment period and until 6 months after treatment.
  9. Must voluntarily sign the Informed Consent Form (ICF), and be able to follow all study requirements and procedures. For the subjects enrolled in Cohort C who are ≥ 12 and < 18 years old, in addition to obtaining the child's own consent, their guardians should provide informed consent and sign the ICF.

Exclusion Criteria:

  1. Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.
  2. Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).
  3. Concurrent participation in another clinical study.
  4. The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.
  5. Have undergone major surgical procedures within 4 weeks prior to the first dose of study treatment or planned to receive major surgery during the study treatment.
  6. Presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to Grade 0 or 1 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 prior to the first dose of study treatment.
  7. Known hypersensitivity to IBI188 or any ingredient in the study drug product.
  8. History of other primary malignancies.
  9. Female subjects who are pregnant or lactating.
  10. Other ineligible conditions considered by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wang Hongping 13436623301 hongping.wang@innoventbio.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04861948
Other Study ID Numbers  ICMJE CIBI188A104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innovent Biologics (Suzhou) Co. Ltd.
Study Sponsor  ICMJE Innovent Biologics (Suzhou) Co. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ba Yi Tianjin Medical University Cancer Institute and Hospital
Principal Investigator: Zhang Dahong Zhejiang Provincial People's Hospital
Principal Investigator: Guo Hongqian The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Principal Investigator: Fang Meiyu Zhejiang Cancer Hospital
Principal Investigator: Xie Yu Hunan Cancer Hospital
Principal Investigator: Liu Jisheng First Affiliated Hospital of Soochow University
Principal Investigator: Wang Ying Zhejiang Provincial People's Hospital
Principal Investigator: Wang Haiying Shougang Hospital, Peking University
Principal Investigator: Wang Mengzhao Shougang Hospital, Peking University
Principal Investigator: Lv Qiang Jiangsu Provincial People's Hospital
Principal Investigator: Li Xiangping Nanfang Hospital of Southern Medical University
Principal Investigator: Liu Guihong The Affiliated Hospital of Xuzhou Medical University
Principal Investigator: Mou Weiqi Chongqing University Cancer Hospital
Principal Investigator: Guo Wei Peking Union Medical College
Principal Investigator: Wang Wei Hunan Cancer Hospital
Principal Investigator: Xu Chongyuan Nanfang Hospital of Southern Medical University
PRS Account Innovent Biologics (Suzhou) Co. Ltd.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP