Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Location status: Recruiting
Location contact
Shengxiang Ren
CONTACT
NCT Number: NCT06605222
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Shanghai, Shanghai Municipality, 200433, China
Location status: Recruiting
Shengxiang Ren
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.
Time frame: first dose of study medication up to 21 days
The Maximum tolerated dose of SHR-7787 injection monotherapy
Time frame: first dose of study medication up to 21 days
The Recommended phase II dose of SHR-7787 injection monotherapy
Time frame: from signature completion of ICF to 60 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: from first dose to 4 weeks
Incidence of Dose Limited Toxicity (DLT) described in the protocol
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
PK parameters of single dose of SHR-7787 injection monotherapy
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
PK parameters of single dose of SHR-7787 injection monotherapy
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
PK parameters of single dose of SHR-7787 injection monotherapy
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
PK parameters of single dose of SHR-7787 injection monotherapy
Time frame: 0.5 hour before first dose through study completion, an average of 1 year
Anti-drug antibody, Immunogenicity of SHR-7787 in monotherapy
Time frame: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months
Objective Response Rate, Efficacy endpoints of SHR-7787 injection monotherapy in treatment of patients with advanced solid tumors
Contact information is provided by the study sponsor or research team.
Shanghai Hengrui Pharmaceutical Co., Ltd.
Industry
A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 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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