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IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

NCT03568539 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-06-01

Study results available
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Summary

The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies.

Patients will be recruited for 2 cohorts:

• Cohort 1: Advanced/metastatic cancers with TMB\>10 mutations per megabase (mut/Mb). This enrollment of this cohort has been stopped per sponsor's communication with the sites. For patients who have already enrolled in this cohort, treatment and monitoring will be conducted as stipulated by the protocol. The patients will remain on study until disease progression or intolerable toxicity, death, withdrawal of consent, or end of study, whichever occurs first.

Cohort 2: Advanced/metastatic endometrial cancer (N=40)

Conditions

  • Advanced/Metastatic Solid Malignancies

Interventions

DRUG

IBI308

IBI308 200mg IV infusion, every 3 weeks.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2020-11-09
Completion
2020-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568539 on ClinicalTrials.gov