The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05836948
• Other study ID #: SHR-9839-I-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2023
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Rongfu Mao, MD
• Phone: +86 021-61053363
• Email: rongfu.mao[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: June 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• SHR-9839
Weekly fixed dose injection of SHR-9839

Locations

Country	Name	City	State
China	Zhejiang Tumor Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) or maximum administered dose (MAD)	Incidence and category of dose limiting toxicities (DLTs) during the first 4 week cycle of SHR-9839 treatment	On the first day of each week,4 weeks is a treatment cycle
Primary	Recommended Phase 2 dose (RP2D)	RP2D will be determined on the basis of evaluation on MTD/MAD, PK, PD, efficacy data in dose escalation and dose expansion stages.	From Day 1 to 90 days after last dose
Primary	Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)	Assess safety and tolerability of SHR-9839 by way of adverse events (CTCAE v5.0).	From Day 1 to 90 days after last dose
Secondary	PK parameter: Tmax of SHR-9839	Time to maximum concentration of SHR-9839	approximately 10 months
Secondary	PK parameter: Cmax of SHR-9839	Maximum concentration of SHR-9839	approximately 10 months
Secondary	PK parameter: AUC0-t of SHR-9839	Area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-9839	Approximately 10 months
Secondary	PK parameter: AUC0-8 of SHR-9839	Area under the concentration-time curve from time 0 to infinity of SHR-9839	Approximately 10 months
Secondary	Immunogenicity of SHR-9839	Anti-SHR-9839 antibody (ADA)	Approximately 12 months
Secondary	Overall response rate (ORR)	Evaluated using RECIST 1.1	Approximately within 36 months
Secondary	Duration of response (DoR)	Evaluated using RECIST 1.1	Approximately within 36 months
Secondary	Disease control rate (DCR)	Evaluated using RECIST 1.1	Approximately within 36 months
Secondary	Progression-free survival (PFS)	Evaluated using RECIST 1.1	Approximately within 36 months