Clinical trial NCT06605222: A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SHR-7787 injection monotherapy
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Patients with unresectable recurrent or metastatic solid tumors;
3. There is at least one lesion could be measured;
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Adequate organ functions as defined;
6. Life expectancy ≥3 months.

Exclusion Criteria:

1. Patients with known active central nervous system (CNS) metastases;
2. Subjects who had other malignancy in five years before the first dose;
3. Patients with tumor-related pain that cannot be controlled as determined;
4. Patients with serious cardiovascular and cerebrovascular diseases;
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
6. Patients with Severe infections;
7. History of immunodeficiency;
8. History of autoimmune diseases;
9. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy
10. Active infection;
11. Pregnant or nursing women;
12. Known history of serious allergic reactions to the investigational product or its main ingredients.

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: first dose of study medication up to 21 days
measure: Recommended phase II dose
timeFrame: first dose of study medication up to 21 days
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: 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
measure: Incidence of Dose Limited Toxicity (DLT)
timeFrame: from first dose to 4 weeks
Secondary outcomes:
measure: Tmax
timeFrame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
measure: Cmax
timeFrame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
measure: AUC0-t
timeFrame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
measure: t1/2
timeFrame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
measure: ADA
timeFrame: 0.5 hour before first dose through study completion, an average of 1 year
measure: ORR
timeFrame: 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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References: