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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-A2009

• Registration Number: NCT05114759
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-10
• Study Start: 2022-01-04
• Last Update Submitted: 2022-10-09
• Last Update Posted: 2022-10-12
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) or maximum administered dose (MAD).	From Day 1 to Day 21	Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A2009 treatment.
Recommended Phase 2 dose (RP2D)	From Day 1 to 90 days after last dose	RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages.
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)	From Day 1 to 90 days after last dose	Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).

Secondary Outcome Measures

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

Trial Locations

Locations (16)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Shandong Cancer Hospital&Institute; 🇨🇳 Jinan, Shandong, China

Chongqing Cancer Hospital; 🇨🇳 Chongqi, Chongqi, China

Fujian Provincial Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

West China Hospital,Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The First Hospital of JiLin University; 🇨🇳 Changchun, Jlin, China

The Second Affiliated Hospital of Air Force Military University Tangdu Hospital; 🇨🇳 Xi'an, Shanxi, China

Sichuan Cancer Hospital & Institute; 🇨🇳 Chengdu, Sichuan, China

First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China

National Cancer Center Hospital East; 🇯🇵 Chiba, Japan

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of