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NCT Number: NCT04324814

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

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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Icon Cancer Care Centre, South Brisbane, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR-1701

Drug

Anti-PD-L1/TGFβ fusion protein

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2020
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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