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Completed Phase 1 Interventional Results available

IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

ClinicalTrials.gov ID: NCT03568539

Public ClinicalTrials.gov record NCT03568539. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 12:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Phase 1b Multicenter Study of IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID
NCT03568539
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
39 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 26, 2018
Primary completion
Nov 8, 2020
Completion
Dec 6, 2020
Last update posted
May 31, 2021

2018 – 2020

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
UC Irvine Medical Center Orange California 92868
Northside Hospital, Inc Atlanta Georgia 30342
Henry Ford Medical Center Detroit Michigan 48202
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169
Icahn School of Medicine at Mount Sinai New York New York 10029
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104
Mary Crowley Cancer Research Dallas Texas 75230

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03568539, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 31, 2021 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03568539 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →