A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Partic… (NCT03941873) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer
China111 participantsStarted 2019-02-28
Plain-language summary
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of sitravatinib as monotherapy and in combination with tislelizumab in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) or gastric/gastroesophageal junction (G/GEJ) cancer.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic HCC/gastric cancer/GEJ cancer
* Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
* Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
* Adequate organ function
* Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drug(s), and have a negative serum pregnancy test ≤ 7 days of first dose of study drug(s)
* Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s)
* Failed current standard-of-care treatment, or standard-of-care treatment is considered not appropriate at present
Key Exclusion Criteria:
* Active leptomeningeal disease or uncontrolled brain metastasis
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Any active malignancy ≤ 2 years before first dose of study drug(s)
* History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis or acute lung diseases
* Severe chronic or active infections (including tuberculosis infection) requiring systemic …
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: Up to approximately 4 years and 1 month
2
Objective Response Rate (ORR)
Timeframe: Up to approximately 4 years and 1 month