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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Or Metastatic Solid Tumor Malignancies
• Intervention / Treatment: Drug: SHR-A2102

• Study Type: Interventional
• Enrollment (Anticipated): 252
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qi Zhang; Phone Number: +0518-81220121; Email: qi.zhang@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-A2102 Does Escalation and Expansion	Drug: SHR-A2102; All participants receive SHR-A2102 alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
OS	Overall survival	24 months
DCR	Disease Control Rate	24 months
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
DoR	Duration of Response	24 months
PFS	Progression-Free-Survival	24 months

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Anticipated): August 31, 2025
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-A2102-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No