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

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects With Advanced Solid Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324814
• Other study ID #: SHR-1701-001AUS
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• SHR-1701
Anti-PD-L1/TGFß fusion protein

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Perth	Western Australia
Australia	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

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Number of subjects with adverse events (AEs)	Screening up to study completion, an average of 1 year
Primary	Laboratory results	Number of subjects with laboratory tests findings of potential clinical importance	Screening up to study completion, an average of 1 year
Primary	Vital signs	Incidence of vital sign abnormalities	Screening up to study completion, an average of 1 year
Primary	Electrocardiogram	Number of subjects with clinically significant abnormal ECG QT Interval	Screening up to study completion, an average of 1 year
Secondary	Pharmacokinetic - Cmax	Maximum observed plasma concentration (Cmax) of SHR-1701	Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
Secondary	Pharmacokinetic - AUC8	Area under the concentration-time curve from time 0 to infinity of SHR-1701	Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
Secondary	Pharmacokinetic - Tmax	Time to Cmax of SHR-1701	Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
Secondary	Pharmacokinetic - CL/F	Apparent clearance of SHR-1701	Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
Secondary	Pharmacokinetic - Vz/F	Apparent volume of distribution during terminal phase of SHR-1701	Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
Secondary	Pharmacokinetic - t1/2	Terminal elimination half-life	Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
Secondary	Pharmacodynamics- ADA	Anti-drug antibody of PD-L1	Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17