A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-7787 injection.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug SHR-7787 injection
Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.
Primary outcome measures
- Maximum tolerated dose [Time frame: first dose of study medication up to 21 days]
- Recommended phase II dose [Time frame: first dose of study medication up to 21 days]
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) [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 of Dose Limited Toxicity (DLT) [Time frame: from first dose to 4 weeks]
Secondary outcome measures (6)
- Tmax [Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose]
- Cmax [Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose]
- AUC0-t [Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose]
- t1/2 [Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose]
- ADA [Time frame: 0.5 hour before first dose through study completion, an average of 1 year]
- ORR [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]
Eligibility criteria
Inclusion criteria
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Patients with unresectable recurrent or metastatic solid tumors;
- There is at least one lesion could be measured;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Adequate organ functions as defined;
- Life expectancy ≥3 months.
Exclusion criteria
- Patients with known active central nervous system (CNS) metastases;
- Subjects who had other malignancy in five years before the first dose;
- Patients with tumor-related pain that cannot be controlled as determined;
- Patients with serious cardiovascular and cerebrovascular diseases;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Patients with Severe infections;
- History of immunodeficiency;
- History of autoimmune diseases;
- Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy
- Active infection;
- Pregnant or nursing women;
- Known history of serious allergic reactions to the investigational product or its main ingredients.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Pulmonary Hospital — Shanghai
Identifiers
NCT: NCT06605222 · SHR-7787-101