IBI188 Combination Therapy in Solid Tumors

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    120
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 28 July 2021
measurable disease
colony stimulating factor
gm-csf
carboplatin

Summary

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

Details
Condition Osteosarcoma, Sarcoma, Solid Tumors, Solid Neoplasm, Lung Adenocarcinoma, Solid Tumour, bone sarcoma
Treatment bevacizumab, Pemetrexed, GM-CSF, Cisplatin/Carboplatin, Sintilimab, IBI188
Clinical Study IdentifierNCT04861948
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on28 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Previous exposure to any CD47 antibody, SIRP antibody, CD47/SIRP 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
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