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

A Phase 1 study testing SHR-1701 in people with Advanced Solid Tumor, run by Atridia Pty Ltd. at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor
What is being tested?: SHR-1701
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 4 sitesAustralia
Study dates: 31 Mar 2020to 1 Feb 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

Linear Clinical Research
Perth, Western Australia
Icon Cancer Care Centre
South Brisbane, New South Wales, 4101
Scientia Clinical research
Sydney, New South Wales
Sydney South West Private
Sydney, New South Wales

Other trials in Australia

About this study

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.

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.

Read the 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.

Conditions: Advanced Solid Tumor
Being tested: SHR-1701

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR-1701Drug
Anti-PD-L1/TGFβ fusion protein

Study groups in NCT04324814
Study group	Role	What they receive
Dose level 1	Experimental	Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: SHR-1701

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events
Number of subjects with adverse events (AEs)
Measured: Screening up to study completion, an average of 1 year
Laboratory results
Number of subjects with laboratory tests findings of potential clinical importance
Measured: Screening up to study completion, an average of 1 year
Vital signs
Incidence of vital sign abnormalities
Measured: Screening up to study completion, an average of 1 year
Electrocardiogram
Number of subjects with clinically significant abnormal ECG QT Interval
Measured: Screening up to study completion, an average of 1 year

Secondary outcomes (7)

Pharmacokinetic - Cmax
Maximum observed plasma concentration (Cmax) of SHR-1701
Measured: 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
Measured: 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
Measured: 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
Apparent clearance of SHR-1701
Measured: 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
Apparent volume of distribution during terminal phase of SHR-1701
Measured: 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 - t1/2
Terminal elimination half-life
Measured: 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
Pharmacodynamics- ADA
Anti-drug antibody of PD-L1
Measured: Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 20201 Feb 2023

First posted27 Mar 2020
Study start31 Mar 2020
Primary completion1 Feb 2023
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
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)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04324814
Sponsor's protocol ID: SHR-1701-001AUS
Status last verified: Feb 2023
First submitted: 28 Nov 2019
Last updated: 21 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT04324814
Acronym / sponsor ID: SHR-1701-001AUS
Conditions: Advanced Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Atridia Pty Ltd.Industry (pharma, biotech, devices)
Study start: 31 Mar 2020 (actual)
Primary completion: 1 Feb 2023 (actual)
Study completion: 1 Feb 2023 (actual)
First posted: 27 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7
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.

Arm	Type	Receives
Dose level 1	Experimental	Drug: SHR-1701Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
Dose level 2	Experimental	Drug: SHR-1701Subjects will receive a single dose of SHR-1701 at Dose level 2 on Day 1 of each cycle
Dose level 3	Experimental	Drug: SHR-1701Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 of each cycle
Dose level 4	Experimental	Drug: SHR-1701Subjects will receive a single dose of SHR-1701 at Dose level 2 1 on Day 1 and Day 15 of each cycle
Dose level 5	Experimental	Drug: SHR-1701Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 and Day 15 of each cycle
Dose expansion 1	Experimental	Drug: SHR-1701Subjects will receive a single dose of SHR-1701 on a selected dose level Day 1 of each cycle
Dose expansion 2	Experimental	Drug: SHR-1701Subjects will receive a single dose of SHR-1701 on a selected dose level on Day 1 of each cycle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SHR-1701Anti-PD-L1/TGFβ fusion protein	Drug	Dose expansion 1, Dose expansion 2, Dose level 1, Dose level 2, Dose level 3, Dose level 4, Dose level 5

Primary outcome

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

7 secondary outcomes

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
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
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
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
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
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
Pharmacodynamics- ADA
Time frame: Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.

Related trials for Advanced Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1701 in people with Advanced Solid Tumor, run by Atridia Pty Ltd. at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: Screening up to study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04324814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.