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

S

Suzhou Suncadia Biopharmaceuticals

Status and phase

Active, not recruiting
Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: SHR-A2009

Study type

Interventional

Funder types

Industry

Identifiers

NCT05394818
SHR-A2009-I-102

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;
  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 active 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

SHR-A2009
Experimental group
Treatment:
Drug: SHR-A2009

Trial contacts and locations

1

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Central trial contact

Wei Shi, Ph.D.; Fei Qiu, MD

Data sourced from clinicaltrials.gov

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