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

NCT05735275 | Unknown Phase 1

• 1 other identifier: SHR-A2102-I-101
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Or Metastatic Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

  30 days after last dose

• ORR

  24 months

Study Arms (1)

SHR-A2102 Does Escalation and Expansion

EXPERIMENTAL

Drug: SHR-A2102

Interventions

SHR-A2102 DRUG

All participants receive SHR-A2102 alone.

SHR-A2102 Does Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Central Study Contacts

Qi Zhang

CONTACT

+0518-81220121; qi.zhang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open, multicenter, Single Group

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 21, 2023
• Study Start: March 3, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 28, 2023

Record last verified: 2023-01

Locations

CN (1)