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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06381050
Other study ID # SHR-7631-101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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