The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

NCT05394818 | Completed Phase 1

• 1 other identifier: SHR-A2009-I-102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, phase I clinical trial of SHR-A2009 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD) or maximum administered dose (MAD)

  Incidence and category of dose limiting toxicities (DLTs) during the first cycle of SHR-A2009 treatment.

  From Day 1 to 90 days after last dose

• Recommended Phase 2 dose (RP2D)

  RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages.

  From Day 1 to 90 days after last dose

• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)

  Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).

  From Day 1 to 90 days after last dose

Secondary Outcomes (9)

• PK parameter: Tmax of SHR-A2009

  approximately 6 months

• PK parameter: Cmax of SHR-A2009

  approximately 6 months

• PK parameter: AUC0-t of SHR-A2009

  approximately 6 months

• PK parameter: AUC0-∞ of SHR-A2009

  approximately 6 months

• Immunogenicity of SHR-A2009

  approximately 9 months

Study Arms (1)

SHR-A2009

EXPERIMENTAL

Drug: SHR-A2009

Interventions

SHR-A2009 DRUG

The total dosage of SHR-A2009 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip.

SHR-A2009

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Have at least one measurable tumor lesion per RECIST v1.1;
• ECOG performance status of 0-1;
• Life expectancy ≥ 12 weeks;
• Adequate bone marrow and organ function.
• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

You may not qualify if:

• Patients with active central nervous system metastases or meningeal metastases;
• Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
• Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
• History of serious cardiovascular and cerebrovascular diseases;
• Severe infection within 4 weeks prior to the first dose;
• Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital-Department of Medical Oncology

Beijing, Beijing Municipality, 100039, China

Location

Study Design

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: July 21, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (1)