A Trial of SHR-1701 in Subjects With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT04324814 |
Recruitment Status :
Active, not recruiting
First Posted : March 27, 2020
Last Update Posted : July 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Advanced Solid Tumor | Drug: SHR-1701 | Phase 1 |
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 completion of dose escalation, 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 31, 2020 |
Estimated Primary Completion Date : | February 2023 |
Estimated Study Completion Date : | February 2023 |
Arm | Intervention/treatment |
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Experimental: Dose level 1
Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
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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 2 on Day 1 of each cycle
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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 3 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 2 1 on Day 1 and Day 15 of each cycle
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Drug: SHR-1701
Anti-PD-L1/TGFβ fusion protein |
Experimental: Dose level 5
Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 and Day 15 of each cycle
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Drug: SHR-1701
Anti-PD-L1/TGFβ fusion protein |
Experimental: Dose expansion 1
Subjects will receive a single dose of SHR-1701 on a selected dose level Day 1 of each cycle
|
Drug: SHR-1701
Anti-PD-L1/TGFβ fusion protein |
Experimental: Dose expansion 2
Subjects will receive a single dose of SHR-1701 on a selected dose level on Day 1 of each cycle
|
Drug: SHR-1701
Anti-PD-L1/TGFβ fusion protein |
- Adverse events [ Time Frame: Screening up to study completion, an average of 1 year ]Number of subjects with adverse events (AEs)
- 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
- Vital signs [ Time Frame: Screening up to study completion, an average of 1 year ]Incidence of vital sign abnormalities
- Electrocardiogram [ Time Frame: Screening up to study completion, an average of 1 year ]Number of subjects with clinically significant abnormal ECG QT Interval
- 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
- 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
- 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
- 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
- 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
- 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
- Pharmacodynamics- ADA [ Time Frame: Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17 ]Anti-drug antibody of PD-L1

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Australia, New South Wales | |
Icon Cancer Care Centre | |
South Brisbane, New South Wales, Australia, 4101 | |
Scientia Clinical research | |
Sydney, New South Wales, Australia | |
Sydney South West Private | |
Sydney, New South Wales, Australia | |
Australia, Western Australia | |
Linear Clinical Research | |
Perth, Western Australia, Australia |
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: | July 13, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms |