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

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ClinicalTrials.gov Identifier: NCT04324814
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Atridia Pty Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: SHR-1701 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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 dose esclation completed, selected cohort(s) will be expanded.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 24, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : September 1, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose level 1
Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
 Drug: SHR-1701
Anti-PD-L1/TGFβ fusion protein
Experimental: Dose level 2
Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
 Drug: SHR-1701
Anti-PD-L1/TGFβ fusion protein
Experimental: Dose level 3
Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
 Drug: SHR-1701
Anti-PD-L1/TGFβ fusion protein
Experimental: Dose level 4
Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 and Day 15 of each cycle
 Drug: SHR-1701
Anti-PD-L1/TGFβ fusion protein


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events [ Time Frame: Screening up to study completion, an average of 1 year ]
    Number of subjects with adverse events (AEs)

  2. Laboratory results [ Time Frame: Screening up to study completion, an average of 1 year ]
    Number of subjects with laboratory tests findings of potential clinical importance

  3. Vital signs [ Time Frame: Screening up to study completion, an average of 1 year ]
    Incidence of vital sign abnormalities

  4. Electrocardiogram [ Time Frame: Screening up to study completion, an average of 1 year ]
    Number of subjects with clinically significant abnormal ECG QT Interval


Secondary Outcome Measures :
  1. Pharmacokinetic - Cmax [ 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 ]
    Maximum observed plasma concentration (Cmax) of SHR-1701

  2. Pharmacokinetic - AUC∞ [ 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 ]
    Area under the concentration-time curve from time 0 to infinity of SHR-1701

  3. Pharmacokinetic - Tmax [ 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 ]
    Time to Cmax of SHR-1701

  4. Pharmacokinetic - CL/F [ 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 ]
    Apparent clearance of SHR-1701

  5. Pharmacokinetic - Vz/F [ 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 ]
    Apparent volume of distribution during terminal phase of SHR-1701

  6. Pharmacokinetic - t1/2 [ 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 ]
    Terminal elimination half-life

  7. Pharmacodynamics- ADA [ Time Frame: Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17 ]
    Anti-drug antibody of PD-L1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324814


Contacts
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Contact: Kathy You, PhD +61 02 9299 0433 kathyyou@atridia.com
Contact: Mengliu Di, Pharm.D +8613057380712 dimengliu@hrglobe.cn

Locations
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Australia, New South Wales
Icon Cancer Care Centre Not yet recruiting
South Brisbane, New South Wales, Australia, 4101
Australia, Western Australia
Linear Clinical Research Recruiting
Perth, Western Australia, Australia
Contact: Meniawy Tarek, Dr.    1300 546 327 (1300Linear)    enquiries@linear.org.au   
Sponsors and Collaborators
Atridia Pty Ltd.
More Information
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Responsible Party: Atridia Pty Ltd.
ClinicalTrials.gov Identifier: NCT04324814    
Other Study ID Numbers: SHR-1701-001AUS
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms