Overview

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

Status:
Not yet recruiting
Trial end date:
2024-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Criteria
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.