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

NCT05154604 | Unknown Phase 1

• 1 other identifier: SHR-A1921-I-101
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Advanced Solid Tumours

Outcome Measures

Primary Outcomes (4)

• Dose Limited Toxicity (DLT)

  21 Days (first cycle)

• Maximum Tolerable Dose (MTD)

  21 Days (first cycle)

• Recommended phase II dose (RP2D)

  Screening up to dose escalation and expansion study completion, appropriately to 1 year

• 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 Outcomes (17)

• Time to reach maximum concentration (Tmax) of SHR-A1921、total antibody

  Screening up to end of treatment, an average of 1 year

• Maximum concentration (Cmax) of SHR-A1921、total antibody

  Screening up to end of treatment, an average of 1 year

• 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

• 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

• Terminal half-life (t1/2) of SHR-A1921、total antibody

  Screening up to end of treatment, an average of 1 year

Study Arms (1)

Treatment group: SHR-A1921

EXPERIMENTAL

Drug: SHR-A1921

Interventions

SHR-A1921 DRUG

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.

Treatment group: SHR-A1921

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and written informed consent；
• Aged 18-75 years (inclusive), males and females;
• Consents to provide tumor tissue samples;
• Subjects must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
• At least one measurable lesion according to RECIST v1.1;
• ECOG score of 0-1;
• Expected survival ≥ 12 weeks;
• Adequate bone marrow reserve and organ function ；
• 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;

You may not qualify if:

• Known and untreated central nervous system (CNS) or leptomeningeal metastases;
• Macrovascular invasion based on imaging;
• Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
• Has a history of a second malignancy;
• History of immunodeficiency disease or organ transplant;
• Uncontrolled cardiac diseases or symptoms;
• Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
• 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;
• Has a history of Grade≥2 bleeding 4 weeks prior to the initiation of the study treatment or is current receiving anticoagulation therapy;
• Subjects with active hepatitis B or active hepatitis C;
• Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
• Has unresolved toxicities from previous anticancer therapy.
• Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921;
• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Central Study Contacts

Quanren Wang, Ph.D

CONTACT

86-021-61053363; quanren.wang@hengrui.com

Di Zong, MS

CONTACT

86-010-67166319; di.zong@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 13, 2021
• Study Start: December 31, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 13, 2021

Record last verified: 2021-11