Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A2102, In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies: A Phase I Open-Label, One-Arm, Multicenter Study.

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country252 target enrollmentMarch 3, 2023

ConditionsAdvanced Or Metastatic Solid Tumor Malignancies

InterventionsSHR-A2102

DrugsSHR-A2102

Overview

Phase: Phase 1
Intervention: SHR-A2102
Conditions: Advanced Or Metastatic Solid Tumor Malignancies
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment: 252
Locations: 1
Primary Endpoint: Dose Limited Toxicity (DLT)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

March 3, 2023

End Date

August 31, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand and the willingness to sign a written informed consent document；
•Aged ≥18 years old;
•Histologically or cytologically confirmed advanced or metastatic malignant tumor;
•Presence of at least one measurable lesion in agreement to RECIST criteria;
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
•Life expectancy ≥3 months;
•Adequate organ performance based on laboratory blood tests;
•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

•Previous received anti-cancer systemic therapy including chemo-therapy, radiation therapy, target therapy or immuno-therapy within 4 weeks before the first dose;
•Previous received experimental medication or therapy within 4 weeks before the first dose;
•Previous therapeutic surgery within 4 weeks;
•Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤
•Known allergic to any compound of SHR-A2102;
•Patients with uncontrolled or active brain metastasis；
•Patients with clinical significant lung disease;
•Patients with history of autoimmune diseases;
•Known active hepatitis B or C infection;
•Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.

Arms & Interventions

SHR-A2102 Does Escalation and Expansion

Intervention: SHR-A2102

Outcomes

Primary Outcomes

Dose Limited Toxicity (DLT)

Time Frame: 21 Days (first cycle)

Maximum tolerable dose (MTD)

Time Frame: 21 Days (first cycle)

Recommended dose for phase II (RP2D)

Time Frame: Up to 8 months

Secondary Outcomes

Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-A2102(30 days after last dose)
Time of maximum observed plasma concentration (Tmax) of SHR-A2102(30 days after last dose)
Immunogenicity Analysis(30 days after last dose)
ORR(24 months)
DCR(24 months)
Maximum observed plasma concentration (Cmax) of SHR-A2102(30 days after last dose)
DoR(24 months)
PFS(24 months)
OS(24 months)