A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.

Hengrui Medicine

Status and phase: Enrolling; Phase 1

Conditions: Advanced Or Metastatic Solid Tumor Malignancies

Treatments: Drug: SHR-A2102

Study type: Interventional

Funder types: Industry

Identifiers

NCT05735275

SHR-A2102-I-101

Details and patient eligibility

About

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

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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252 participants in 1 patient group

SHR-A2102 Does Escalation and Expansion

Experimental group

Treatment:

Drug: SHR-A2102