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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose (MTD) or maximum administered dose (MAD)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SHR-9839
three stages: dose escalation, dose expansion and efficacy expansion.
Intervention: SHR-9839 (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD) or maximum administered dose (MAD)
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
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
Assess safety and tolerability of SHR-9839 by way of adverse events (CTCAE v5.0).
Recommended Phase 2 dose (RP2D)
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.
Secondary Outcomes
- PK parameter: Tmax of SHR-9839(approximately 10 months)
- PK parameter: AUC0-t of SHR-9839(Approximately 10 months)
- Duration of response (DoR)(Approximately within 36 months)
- PK parameter: AUC0-∞ of SHR-9839(Approximately 10 months)
- Disease control rate (DCR)(Approximately within 36 months)
- PK parameter: Cmax of SHR-9839(approximately 10 months)
- Immunogenicity of SHR-9839(Approximately 12 months)
- Overall response rate (ORR)(Approximately within 36 months)
- Progression-free survival (PFS)(Approximately within 36 months)