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Trial Title:
A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.
NCT ID:
NCT05735275
Condition:
Advanced Or Metastatic Solid Tumor Malignancies
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
open, multicenter, Single Group
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A2102
Description:
All participants receive SHR-A2102 alone.
Arm group label:
SHR-A2102 Does Escalation and Expansion
Summary:
This is a first in human, open-label, single-arm, multicenter dose escalation and
expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid
tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics
and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ability to understand and the willingness to sign a written informed consent
document;
2. Aged ≥18 years old;
3. Histologically or cytologically confirmed advanced or metastatic malignant tumor;
4. Presence of at least one measurable lesion in agreement to RECIST criteria;
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
6. Life expectancy ≥3 months;
7. Adequate organ performance based on laboratory blood tests;
8. Women of childbearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation.
Exclusion Criteria:
1. Previous received anti-cancer systemic therapy including chemo-therapy, radiation
therapy, target therapy or immuno-therapy within 4 weeks before the first dose;
2. Previous received experimental medication or therapy within 4 weeks before the first
dose;
3. Previous therapeutic surgery within 4 weeks;
4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities
not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
5. Known allergic to any compound of SHR-A2102;
6. Patients with uncontrolled or active brain metastasis;
7. Patients with clinical significant lung disease;
8. Patients with history of autoimmune diseases;
9. Known active hepatitis B or C infection;
10. Other serious accompanying illnesses, which, in the investigator's assessment, could
seriously adversely affect the safety of the treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Investigator:
Last name:
Jun Guo
Email:
Principal Investigator
Start date:
March 3, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05735275