Zhejiang Tumor Hospital
Hangzhou, Zhejiang, 310006, China
Location status: Recruiting
NCT Number: NCT05836948
This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 1
Hangzhou, Zhejiang, 310006, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly fixed dose injection of SHR-9839
Time frame: On the first day of each week,4 weeks is a treatment cycle
Incidence and category of dose limiting toxicities (DLTs) during the first 4 week cycle of SHR-9839 treatment
Time frame: From Day 1 to 90 days after last dose
RP2D will be determined on the basis of evaluation on MTD/MAD, PK, PD, efficacy data in dose escalation and dose expansion stages.
Time frame: From Day 1 to 90 days after last dose
Assess safety and tolerability of SHR-9839 by way of adverse events (CTCAE v5.0).
Time frame: approximately 10 months
Time to maximum concentration of SHR-9839
Time frame: approximately 10 months
Maximum concentration of SHR-9839
Time frame: Approximately 10 months
Area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-9839
Time frame: Approximately 10 months
Area under the concentration-time curve from time 0 to infinity of SHR-9839
Time frame: Approximately 12 months
Anti-SHR-9839 antibody (ADA)
Time frame: Approximately within 36 months
Evaluated using RECIST 1.1
Time frame: Approximately within 36 months
Evaluated using RECIST 1.1
Time frame: Approximately within 36 months
Evaluated using RECIST 1.1
Time frame: Approximately within 36 months
Evaluated using RECIST 1.1
Contact information is provided by the study sponsor or research team.
Jin Wang, COD
CONTACT
Rongfu Mao, MD
CONTACT
Shanghai Hengrui Pharmaceutical Co., Ltd.
Industry
An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection in Patients With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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