The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7631 for Injection in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381050
• Other study ID #: SHR-7631-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Xiaoyu Zhu
• Phone: +86 021-61053363
• Email: zhuxiaoyu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label, phase I clinical trial of SHR-7631 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: 150
• Est. completion date: April 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 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 (subject with only non-target tumor lesion will be permitted if he/she is planned to participant in dose escalation stage or with mCRPC);

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.

7. Age 18 to 75 years old (including both ends), gender is not limited;

Exclusion Criteria:

1. Patients with active central nervous system metastases or meningeal metastases;

2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;

3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;

4. History of serious cardiovascular and cerebrovascular diseases;

5. Severe infection within 4 weeks prior to the first dose;

6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade = 1 per NCI-CTCAE v5.0.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• SHR-7631
The total dosage of SHR-7631 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals 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)		12 months
Primary	Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0)		36 months
Secondary	PK parameter: Tmax		36 months
Secondary	PK parameter: Cmax		36 months
Secondary	PK parameter: AUC0-t		36 months
Secondary	PK parameter: AUC0-8		36 months
Secondary	PK parameter: t1/2		36 months
Secondary	PK parameter: MRT (mean residence time)		36 months