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

A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SHR-A2009

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei Shi, MD, PhD; Phone Number: +86 021-61053363; Email: wei.shi@hengrui.com

Study Locations

• China
  • Chongqi
    • Chongqi, Chongqi, China, 400000
      • Recruiting
      • Chongqing Cancer Hospital
      • Principal Investigator: Yongsheng Li
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Not yet recruiting
      • Fujian Provincial Cancer Hospital
      • Principal Investigator: Gen Lin
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Principal Investigator: Yilong Wu
      • Principal Investigator: Qing Zhou
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Hunan Cancer Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Principal Investigator: Anwen Liu
      • Principal Investigator: Jian Li
  • Jlin
    • Changchun, Jlin, China, 132000
      • Recruiting
      • The First Hospital of Jilin University
      • Principal Investigator: Jiuwei Cui
  • Shandong
    • Jinan, Shandong, China, 250000
      • Not yet recruiting
      • Shandong Cancer Hospital&Institute
      • Principal Investigator: Yan Zhang
      • Principal Investigator: Shuqin Ni
  • Shanxi
    • Xi'an, Shanxi, China, 710000
      • Not yet recruiting
      • The Second Affiliated Hospital of Air Force Military University Tangdu Hospital
      • Principal Investigator: Haichuan Su
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Not yet recruiting
      • Sichuan Cancer Hospital & Institute
    • Chengdu, Sichuan, China, 610000
      • Not yet recruiting
      • West China Hospital,Sichuan University
      • Principal Investigator: Yan Zhang
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • Not yet recruiting
      • First Affiliated Hospital of Kunming Medical University
      • Principal Investigator: Jin Liang
• Japan
  • Chiba, Japan, 277-8577
    • Not yet recruiting
    • National Cancer Center Hospital East
    • Principal Investigator: Yasutoshi Kuboki
  • Tokyo, Japan, 104-0045
    • Not yet recruiting
    • National Cancer Center Hospital
    • Principal Investigator: Noboru Yamamoto
• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Not yet recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Not yet recruiting
    • Samsung Medical Center
    • Principal Investigator: Jong Mu Sun
  • Seoul, Korea, Republic of, 03080
    • Not yet recruiting
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage);
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.

Exclusion Criteria:

1. Patients with symptomatic 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-A2009 for Injection will be administrated per dose level in which the patients are assigned.	Drug: SHR-A2009; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of SHR-A2009	Anti-SHR-A2009 antibody (ADA)	approximately 9 months
Overall response rate (ORR)	Evaluated using RECIST 1.1	approximately within 36 months
Duration of response (DoR)	Evaluated using RECIST 1.1	approximately within 36 months
Disease control rate (DCR)	Evaluated using RECIST 1.1	approximately within 36 months
Progression-free survival (PFS)	Evaluated using RECIST 1.1	approximately within 36 months
Tmax of SHR-A2009	Time to maximum concentration of SHR-A2009	approximately 6 months
Cmax of SHR-A2009	Maximum concentration of SHR-A2009	approximately 6 months
AUC0-t of SHR-A2009	area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-A2009	approximately 6 months
AUC0-∞ of SHR-A2009	area under the concentration-time curve from time 0 to infinity of SHR-A2009	approximately 6 months

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-A2009-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No