Recruiting NCT05836948
The Clinical Study of SHR-9839 for 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-9839.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor. Basic parameters: 18 years — 70 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
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
Overview
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.
Interventions
- Drug SHR-9839
Weekly fixed dose injection of SHR-9839
Primary outcome measures
- Maximum tolerated dose (MTD) or maximum administered dose (MAD) [Time frame: On the first day of each week,4 weeks is a treatment cycle]
- Recommended Phase 2 dose (RP2D) [Time frame: From Day 1 to 90 days after last dose]
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0) [Time frame: From Day 1 to 90 days after last dose]
Secondary outcome measures (9)
- PK parameter: Tmax of SHR-9839 [Time frame: approximately 10 months]
- PK parameter: Cmax of SHR-9839 [Time frame: approximately 10 months]
- PK parameter: AUC0-t of SHR-9839 [Time frame: Approximately 10 months]
- PK parameter: AUC0-∞ of SHR-9839 [Time frame: Approximately 10 months]
- Immunogenicity of SHR-9839 [Time frame: Approximately 12 months]
- Overall response rate (ORR) [Time frame: Approximately within 36 months]
- Duration of response (DoR) [Time frame: Approximately within 36 months]
- Disease control rate (DCR) [Time frame: Approximately within 36 months]
- Progression-free survival (PFS) [Time frame: Approximately within 36 months]
Eligibility criteria
Inclusion criteria
- Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
- Have at least one measurable tumor lesion per RECIST v1.1;
- ECOG performance status of 0-1;
- Life expectancy ≥ 12 weeks;
- Adequate bone marrow and organ function;
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
Exclusion criteria
- Patients with active central nervous system metastases or meningeal metastases;
- Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;
- History of serious cardiovascular and cerebrovascular diseases;
- Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
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
- Zhejiang Tumor Hospital — Hangzhou
Identifiers
NCT: NCT05836948 · SHR-9839-I-101