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

Phase 1

Recruiting

• Conditions: Advanced Or Metastatic Solid Tumor Malignancies
• Interventions: Drug: SHR-A2102

• Registration Number: NCT05735275
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Study Start: 2023-03-03
• Last Update Submitted: 2023-03-26
• Last Update Posted: 2023-03-28
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-A2102 Does Escalation and Expansion	SHR-A2102	-

Primary Outcome Measures

Name	Time	Method
Dose Limited Toxicity (DLT)	21 Days (first cycle)
Maximum tolerable dose (MTD)	21 Days (first cycle)
Recommended dose for phase II (RP2D)	Up to 8 months

Secondary Outcome Measures

Name	Time	Method
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	ADA
ORR	24 months	Objective Response Rate
DCR	24 months	Disease Control Rate
Maximum observed plasma concentration (Cmax) of SHR-A2102	30 days after last dose
DoR	24 months	Duration of Response
PFS	24 months	Progression-Free-Survival
OS	24 months	Overall survival

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China