A Trial of SHR-1701 in Subjects With Advanced Solid Tumors

NCT ID: NCT04324814

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2023-02-01

Brief Summary

This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with advanced solid tumors.

Detailed Description

This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase 1 study of repeated doses of SHR-1701 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose level 1

Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle

Group Type: EXPERIMENTAL

SHR-1701

Intervention Type: DRUG

Anti-PD-L1/TGFβ fusion protein

Dose level 2

Subjects will receive a single dose of SHR-1701 at Dose level 2 on Day 1 of each cycle

Group Type: EXPERIMENTAL

SHR-1701

Intervention Type: DRUG

Anti-PD-L1/TGFβ fusion protein

Dose level 3

Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 of each cycle

Group Type: EXPERIMENTAL

SHR-1701

Intervention Type: DRUG

Anti-PD-L1/TGFβ fusion protein

Dose level 4

Subjects will receive a single dose of SHR-1701 at Dose level 2 1 on Day 1 and Day 15 of each cycle

Group Type: EXPERIMENTAL

SHR-1701

Intervention Type: DRUG

Anti-PD-L1/TGFβ fusion protein

Dose level 5

Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 and Day 15 of each cycle

Group Type: EXPERIMENTAL

SHR-1701

Intervention Type: DRUG

Anti-PD-L1/TGFβ fusion protein

Dose expansion 1

Subjects will receive a single dose of SHR-1701 on a selected dose level Day 1 of each cycle

Group Type: EXPERIMENTAL

SHR-1701

Intervention Type: DRUG

Anti-PD-L1/TGFβ fusion protein

Dose expansion 2

Subjects will receive a single dose of SHR-1701 on a selected dose level on Day 1 of each cycle

Group Type: EXPERIMENTAL

SHR-1701

Intervention Type: DRUG

Anti-PD-L1/TGFβ fusion protein

Interventions

SHR-1701

Anti-PD-L1/TGFβ fusion protein

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosed (histologically or cytologically) with solid tumors
• ECOG Performance Status of 0 or 1 at both the screening and baseline visits
• Life expectancy ≥12 weeks
• Adequate laboratory parameters
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

Exclusion Criteria

• Known history of hypersensitivity to the study drug
• Prior malignancy active within the previous 2 years
• Any investigational or concurrent cancer therapy
• History of immunodeficiency including seropositivity
• Systemic antibiotics treatment for ≥ 7 days before the first dose
• A known history of allogeneic organ transplantation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atridia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Icon Cancer Care Centre

South Brisbane, New South Wales, Australia

Scientia Clinical research

Sydney, New South Wales, Australia

Sydney South West Private

Sydney, New South Wales, Australia

Linear Clinical Research

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

SHR-1701-001AUS

Identifier Type: -

Identifier Source: org_study_id