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

Atridia Pty Ltd.41 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor

Interventions

SHR-1701DRUG

Anti-PD-L1/TGFβ fusion protein

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Adverse events

Number of subjects with adverse events (AEs)

Time frame: Screening up to study completion, an average of 1 year

Laboratory results

Number of subjects with laboratory tests findings of potential clinical importance

Time frame: Screening up to study completion, an average of 1 year

Vital signs

Incidence of vital sign abnormalities

Time frame: Screening up to study completion, an average of 1 year

Electrocardiogram

Number of subjects with clinically significant abnormal ECG QT Interval

Time frame: Screening up to study completion, an average of 1 year

Secondary Outcomes

Pharmacokinetic - Cmax

Maximum observed plasma concentration (Cmax) of SHR-1701

Time frame: 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

Pharmacokinetic - AUC∞

Area under the concentration-time curve from time 0 to infinity of SHR-1701

Time frame: 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

Pharmacokinetic - Tmax

Time to Cmax of SHR-1701

Time frame: 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

Pharmacokinetic - CL/F

Data from ClinicalTrials.gov

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