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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

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