A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

NCT05114759 | Active Not Recruiting Phase 1

• 1 other identifier: SHR-A2009-I-101
• Study Type: interventional
• Target: 176
• Locations: 3 countries
• Sites: 16

Brief Summary

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

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 21-day cycle of SHR-A2009 treatment.

  From Day 1 to Day 21

• 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)

• Tmax of SHR-A2009

  approximately 6 months

• Cmax of SHR-A2009

  approximately 6 months

• AUC0-t of SHR-A2009

  approximately 6 months

• AUC0-∞ of SHR-A2009

  approximately 6 months

• Immunogenicity of SHR-A2009

  approximately 9 months

Study Arms (1)

SHR-A2009 for Injection will be administrated per dose level in which the patients are assigned.

EXPERIMENTAL

Drug: SHR-A2009

Interventions

SHR-A2009 DRUG

In dose Escalation: SHR-A2009 will be administered intravenously. Six dose levels are preset. In dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.

SHR-A2009 for Injection will be administrated per dose level in which the patients are assigned.

Eligibility Criteria

• Age: 18 Years - 70 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 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage);
• 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 symptomatic 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 (16)

Chongqing Cancer Hospital

Chongqicun, Chongqi, 400000, China

Location

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

The First Hospital of JiLin University

Changchun, Jlin, 132000, China

Location

Shandong Cancer Hospital&Institute

Jinan, Shandong, 250000, China

Location

The Second Affiliated Hospital of Air Force Military University Tangdu Hospital

Xi’an, Shanxi, 710000, China

Location

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610000, China

Location

West China Hospital,Sichuan University

Chengdu, Sichuan, 610000, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

National Cancer Center Hospital East

Chiba, Chiba, 277-8577, Japan

Location

National Cancer Center Hospital

Tokyo, Tokyo, 104-0045, Japan

Location

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

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 arm study of SHR-A2009

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 10, 2021
• Study Start: January 4, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

CN (11); JP (2); KR (3)