IBI188 Combination Therapy in Solid Tumors

NCT04861948 | Terminated Phase 1

• 1 other identifier: CIBI188A104
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumors; Lung Adenocarcinoma; Osteosarcoma

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  24 months

• Adverse Events

  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)

  24 months

Secondary Outcomes (13)

• Progression-free survival

  24 months

• Overall survival

  24 months

• Disease control rate

  24 months

• Duration of response

  24 months

• Time to response

  24 months

Study Arms (4)

Cohort A

EXPERIMENTAL

Drug: IBI188; Drug: Sintilimab

Cohort B

EXPERIMENTAL

Drug: IBI188; Drug: Cisplatin/Carboplatin; Drug: Bevacizumab; Drug: Pemetrexed

Cohort C

EXPERIMENTAL

Drug: IBI188; Drug: GM-CSF

Cohort D

EXPERIMENTAL

Drug: IBI188; Drug: Sintilimab

Interventions

IBI188 DRUG

intravenous

Cohort A; Cohort B; Cohort C; Cohort D

GM-CSF DRUG

subcutaneous injection

Cohort C

Cisplatin/Carboplatin DRUG

intravenous

Cohort B

Bevacizumab DRUG

intravenous

Cohort B

Sintilimab DRUG

intravenous

Cohort A; Cohort D

Pemetrexed DRUG

intravenous

Cohort B

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .
• Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).
• Able to provide archived or fresh tumor tissue samples for biomarker assessment.
• Have at least one measurable lesion according to RECIST version 1.1.
• ECCG PS score of 0-2.
• Adequate organ and bone marrow functions .
• Life expectancy ≥ 12 weeks.
• 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.
• 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.

You may not qualify if:

• Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.
• Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).
• Concurrent participation in another clinical study.
• The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.
• 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.
• 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.
• Known hypersensitivity to IBI188 or any ingredient in the study drug product.
• History of other primary malignancies.
• Female subjects who are pregnant or lactating.
• Other ineligible conditions considered by the investigator.

Sponsors & Collaborators

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

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Osteosarcoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Cisplatin; Carboplatin; Bevacizumab; sintilimab; Pemetrexed

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• 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, 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, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: May 25, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Locations

CN (1)