A Study of SHR-A1921 for Injection in Subjects With Advanced Solid Tumours

Advanced Solid Tumours Clinical Trial

Official title:

A Phase 1 Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1921 in Subjects With Advanced Malignant Solid Tumour .

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05154604
• Other study ID #: SHR-A1921-I-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 31, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2021
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Quanren Wang, Ph.D
• Phone: 86-021-61053363
• Email: quanren.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the safety and tolerability of SHR-A1921 in patients with advanced solid tumours, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of SHR-A1921

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Voluntary participation and written informed consent;

2. Aged 18-75 years (inclusive), males and females;

3. Consents to provide tumor tissue samples;

4. Subjects must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;

5. At least one measurable lesion according to RECIST v1.1;

6. ECOG score of 0-1;

7. Expected survival = 12 weeks;

8. Adequate bone marrow reserve and organ function ;

9. For female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; For female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum HCG test result within 72 h prior to study enrollment; and they must not be in the lactation period;

Exclusion Criteria:

1. Known and untreated central nervous system (CNS) or leptomeningeal metastases;

2. Macrovascular invasion based on imaging;

3. Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;

4. Has a history of a second malignancy;

5. History of immunodeficiency disease or organ transplant;

6. Uncontrolled cardiac diseases or symptoms;

7. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;

8. Has a history of active chronic enteritis 6 weeks prior to the initiation of the study treatment or intestinal obstruction, gastrointestinal perforation 3 months prior to the initiation of the study treatment;

9. Has a history of Grade=2 bleeding 4 weeks prior to the initiation of the study treatment or is current receiving anticoagulation therapy;

10. Subjects with active hepatitis B or active hepatitis C;

11. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.

12. Has unresolved toxicities from previous anticancer therapy.

13. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921;

14. Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.

Related Conditions & MeSH terms

• Advanced Solid Tumours
• Neoplasms

Intervention

Drug:
• SHR-A1921
Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limited Toxicity (DLT)		21 Days (first cycle)
Primary	Maximum Tolerable Dose (MTD)		21 Days (first cycle)
Primary	Recommended phase II dose (RP2D)		Screening up to dose escalation and expansion study completion, appropriately to 1 year
Primary	Adverse Events	Incidence and grade of adverse events as assessed by CTCAE v5.0	Screening up to study completion, an average of 1 year
Secondary	Time to reach maximum concentration (Tmax) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Maximum concentration (Cmax) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Area under the concentration-time curve from time zero to the time of the last quantifiable time point t (AUC0-t) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-t) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Terminal half-life (t1/2) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Total body clearance (CL) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Volume of distribution at steady state (Vss) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Mean residence time (MRT) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Maximum steady-state drug concentration during a dosage interval (Css, max) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Minimum steady-state drug concentration during a dosage interval (Css, min) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Accumulation ratio (Rac) of SHR-A1921?total antibody		Screening up to end of treatment, an average of 1 year
Secondary	Anti-drug antibody(ADA) level of SHR-A1921		Screening up to 90 days after the last dose, an average of 1 year
Secondary	Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Duration of Response (DoR) assessed by site investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Disease Control Rate (DCR) assessed by site investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Progression-Free Survival (PFS) assessed by site investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Overall Survival (OS)		Screening up to study completion, an average of 1 year