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

NCT04324814 | Completed Phase 1 DMC

• 1 other identifier: SHR-1701-001AUS
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Adverse events

  Number of subjects with adverse events (AEs)

  Screening up to study completion, an average of 1 year

• Laboratory results

  Number of subjects with laboratory tests findings of potential clinical importance

  Screening up to study completion, an average of 1 year

• Vital signs

  Incidence of vital sign abnormalities

  Screening up to study completion, an average of 1 year

• Electrocardiogram

  Number of subjects with clinically significant abnormal ECG QT Interval

  Screening up to study completion, an average of 1 year

Secondary Outcomes (7)

• Pharmacokinetic - Cmax

  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∞

  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

  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

  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 - Vz/F

  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

Study Arms (7)

Dose level 1

EXPERIMENTAL

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

Drug: SHR-1701

Dose level 2

EXPERIMENTAL

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

Drug: SHR-1701

Dose level 3

EXPERIMENTAL

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

Drug: SHR-1701

Dose level 4

EXPERIMENTAL

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

Drug: SHR-1701

Dose level 5

EXPERIMENTAL

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

Drug: SHR-1701

Dose expansion 1

EXPERIMENTAL

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

Drug: SHR-1701

Dose expansion 2

EXPERIMENTAL

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

Drug: SHR-1701

Interventions

SHR-1701 DRUG

Anti-PD-L1/TGFβ fusion protein

Dose expansion 1; Dose expansion 2; Dose level 1; Dose level 2; Dose level 3; Dose level 4; Dose level 5

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (4)

Icon Cancer Care Centre

South Brisbane, New South Wales, 4101, Australia

Location

Scientia Clinical research

Sydney, New South Wales, Australia

Location

Sydney South West Private

Sydney, New South Wales, Australia

Location

Linear Clinical Research

Perth, Western Australia, Australia

Location

MeSH Terms

Interventions

SHR-1701

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation is designed according to a modified 3+3 scheme, in which 3 to 6 subjects will be enrolled in each dose group. Four dose levels of SHR-1701 are planned. After completion of dose escalation, selected cohort(s) will be expanded.

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: March 27, 2020
• Study Start: March 31, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

AU (4)