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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.

Brief Summary:
A Phase Ib study aim to explore the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies

Condition or disease Intervention/treatment Phase
Solid Tumors Lung Adenocarcinoma Osteosarcoma Drug: IBI188 Drug: GM-CSF Drug: Cisplatin/Carboplatin Drug: Bevacizumab Drug: Sintilimab Drug: Pemetrexed Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Study to Evaluate the Efficacy, Safety and Tolerability of IBI188 Combination Therapy in Subjects With Advanced Malignancies
Actual Study Start Date : May 25, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A Drug: IBI188
intravenous

Drug: Sintilimab
intravenous

Experimental: Cohort B Drug: IBI188
intravenous

Drug: Cisplatin/Carboplatin
intravenous

Drug: Bevacizumab
intravenous

Drug: Pemetrexed
intravenous

Experimental: Cohort C Drug: IBI188
intravenous

Drug: GM-CSF
subcutaneous injection

Experimental: Cohort D Drug: IBI188
intravenous

Drug: Sintilimab
intravenous




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 24 months ]
  2. 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)


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 24 months ]
  2. Overall survival [ Time Frame: 24 months ]
  3. Disease control rate [ Time Frame: 24 months ]
  4. Duration of response [ Time Frame: 24 months ]
  5. Time to response [ Time Frame: 24 months ]
  6. Area Under Curve, AUC [ Time Frame: 24 months ]
  7. maximum concentration (Cmax) [ Time Frame: 24 months ]
  8. minimum concentration (Cmin) [ Time Frame: 24 months ]
  9. clearance (CL) [ Time Frame: 24 months ]
  10. volume of distribution (V) [ Time Frame: 24 months ]
  11. half-life (t1/2) [ Time Frame: 24 months ]
  12. Positive rate of anti-drug antibody (ADA) [ Time Frame: 24 months ]
  13. Positive rate of neutralizing antibody (NAb) [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861948


Contacts
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Contact: Wang Hongping 13436623301 hongping.wang@innoventbio.com

Locations
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China
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, China
Contact: Ba Yi    86-022-23340123    bayi@tjmch.com   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
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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
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04861948    
Other Study ID Numbers: CIBI188A104
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteosarcoma
Adenocarcinoma of Lung
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Bevacizumab
Carboplatin
Pemetrexed
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors