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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Advanced Or Metastatic Solid Tumor Malignancies

Intervention / Treatment
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* Drug: SHR-A2102


Participation Criteria
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Eligibility Criteria
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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 ≤ 1. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open, multicenter, Single Group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-A2102 Does Escalation and Expansion<br> | Drug: SHR-A2102<br>* All participants receive SHR-A2102 alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-A2102 |  | 30 days after last dose | 
| Maximum observed plasma concentration (Cmax) 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 | ADA | 30 days after last dose | 
| ORR | Objective Response Rate | 24 months | 
| DCR | Disease Control Rate | 24 months | 
| DoR | Duration of Response | 24 months | 
| PFS | Progression-Free-Survival | 24 months | 
| OS | Overall survival | 24 months |