Clinical trial NCT05836948: The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-01
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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;
2. Have at least one measurable tumor lesion per RECIST v1.1;
3. ECOG performance status of 0-1;
4. Life expectancy ≥ 12 weeks;
5. Adequate bone marrow and organ function;
6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Patients with active central nervous system metastases or meningeal metastases;
2. 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;
3. History of serious cardiovascular and cerebrovascular diseases;
4. 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;
5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Primary outcomes:
measure: Maximum tolerated dose (MTD) or maximum administered dose (MAD)
timeFrame: On the first day of each week,4 weeks is a treatment cycle
measure: Recommended Phase 2 dose (RP2D)
timeFrame: From Day 1 to 90 days after last dose
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)
timeFrame: From Day 1 to 90 days after last dose
Secondary outcomes:
measure: PK parameter: Tmax of SHR-9839
timeFrame: approximately 10 months
measure: PK parameter: Cmax of SHR-9839
timeFrame: approximately 10 months
measure: PK parameter: AUC0-t of SHR-9839
timeFrame: Approximately 10 months
measure: PK parameter: AUC0-∞ of SHR-9839
timeFrame: Approximately 10 months
measure: Immunogenicity of SHR-9839
timeFrame: Approximately 12 months
measure: Overall response rate (ORR)
timeFrame: Approximately within 36 months
measure: Duration of response (DoR)
timeFrame: Approximately within 36 months
measure: Disease control rate (DCR)
timeFrame: Approximately within 36 months
measure: Progression-free survival (PFS)
timeFrame: Approximately within 36 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Tumor Hospital
state: Zhejiang
Study officials:
References: