Physiological Effects of DrugsPhase 1NCT03722186
Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies
A Phase 1 study testing SHR-1603 in people with Physiological Effects of Drugs and Neoplasms by Histologic Type, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The study drug will be administered by intravenous infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physiological Effects of Drugs, Neoplasms by Histologic Type, Lymphoma
- What is being tested?
- SHR-1603
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2018to Oct 2021
- 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
- Ages 18 years or older;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Life expectancy no less than 12 weeks;
- Pathologically confirmed advanced solid tumor or relapsed/refractory lymphoma with measurable target lesions;
- Adequate bone marrow, haptic, renal and coagulation function.
Who cannot join
- Evidence of central nervous system (CNS) involvement;
- Previously treated with similar agents;
- History of anticancer treatment within 4 weeks of enrollment (6 weeks for subjects treated with nitrosoureas or mitomycins);
- Anticipated to be involved in other anti-cancer treatments expect for palliative care during the trial;
- History of anti-cancer vaccination; or history of vaccination using attenuated vaccines within 4 weeks of enrollment;
- History of Red blood cell (RBC) transfusion within or treatment with erythropoitin(EPO) within 3 months of enrollment;
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- History of grade 3 or higher thrombolic incidence within 2 years of enrollment, or using antithrombotic/anticoagulant agents;
- With confirmed immunodeficiency, uncontrolled auto-immune disease, uncontrolled cardiovascular disease, uncontrolled or active infection;
- Substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-arm, Phase I Study of the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of SHR-1603 in Subjects With Advanced Solid Tumor or Relapsed/Refractory Lymphoma
SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The study drug will be administered by intravenous infusion.
Read the detailed description
SHR-1603-I-101 is a single-arm, open-label, dose finding, first-in-human(FIH) clinical trial of SHR-1603 intravenous infusion in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases.
The primary objective of this study is to evaluate the safety and tolerability of SHR-1603, as well as to determine the maximally tolerated dose(MTD) and define the recommended Phase 2 dose(RP2D) of SHR-1603.
The study is consisted of a dose-escalation Part 1 followed by a dose expansion Part 2 and a clinical expansion Part 3.
Part 1 will use accelerated titration and 3+3 dose-escalation design to determine MTD.
Part 2 will further evaluate the safety, tolerability and PK/PD features of SHR-1603 based on the results of Part 1.
Part 3 will include several cohorts of malignancies to collect preliminary efficacy information of SHR-1603.
- Conditions
- Physiological Effects of Drugs, Neoplasms by Histologic Type, Lymphoma, Hematologic Neoplasms, Immunotherapy, Advanced Cancer
- Being tested
- SHR-1603
- Keywords
- advanced solid tumor, R/R lymphoma
- Medical subject headings
- Neoplasms by Histologic Type, Lymphoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1603Drug
SHR-1603 monotherapy
| Study group | Role | What they receive |
|---|---|---|
| SHR-1603 | Experimental | Multiple escalating doses of SHR-1603 Receives: Drug: SHR-1603 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events(AE) of SHR-1603
Assessment of the incidence of treatment-emergent AEs
Measured: 18 months (anticipated)
Dose-limited toxicity (DLT) of SHR-1603
Assessment of the incidence of DLT
Measured: 18 months(anticipated)
Maximum tolerated dose (MTD) of SHR-1603
The highest dosing level at which no more than 1 of 6 patients has DLT
Measured: 18 months(anticipated)
Secondary outcomes (11)
The peak plasma concentration (Cmax) of SHR-1603
The serum concentrations of SHR-1603 at each dose level, between the first and second intravenous administration.
Measured: 18 months (anticipated)
The area under the plasma concentration versus time curve (AUC) of SHR-1603
The plot of SHR-1603 concentration in blood plasma versus time after intravenous infusion.
Measured: 18 months (anticipated)
The half-life(t1/2) of SHR-1603
The time required for the serum concentration of SHR-1603 be reduced to half of its peak concentration.
Measured: 18 months (anticipated)
The objective response rate(ORR) in subjects with advanced tumors treated with SHR-1603
The proportion of patients with reduction in tumor burden. RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment.
Measured: 36 months
The best of response (BOR) in subjects with advanced tumors treated with SHR-1603
The best response recorded from the start of the study treatment until the disease progression. RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment.
Measured: 36 months
The progression free survival (PFS) in subjects with advanced tumors treated with SHR-1603
Time from the first dose of SHR-1603 until disease progression or death. Disease progression will be determined according to RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma).
Measured: 36 months
The Duration of response (DoR) in subjects with advanced tumors treated with SHR-1603
Time from documentation of tumor response to disease progression. RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment.
Measured: 36 months
The disease control rate (DCR) in subjects with advanced tumors treated with SHR-1603
The percentage of subjects with solid tumor who have achieved complete response(CR), partial response(PR) and stable disease(SD) no less than 24 weeks since start of treatment. RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment.
Measured: 36 months
The clinical benefit rate (CBR) in subjects with advanced tumors treated with SHR-1603
The percentage of subjects with solid tumor who have achieved complete response(CR), partial response(PR) and stable disease(SD). RECIST 1.1(solid tumor) or LUGANO 2014(lymphoma) will be used for assessment.
Measured: 36 months
SHR-1603 receptor occupation
red blood cell and white blood cell surface receptor occupation will be assessed frequently
Measured: 30 months
SHR-1603 antibodies
anti SHR-1603 antibodies will be tested frequently
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start13 Nov 2018
- Primary completion4 Apr 2019
- Study completionOct 2021 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Effects of DrugsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722186
- Sponsor's protocol ID
- SHR-1603-I-101
- Status last verified
- Mar 2021
- First submitted
- 25 Oct 2018
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Phase I Study of the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of SHR-1603 in Subjects With Advanced Solid Tumor or Relapsed/Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT03722186
- Acronym / sponsor ID
- SHR-1603-I-101
- Conditions
- Physiological Effects of Drugs, Neoplasms by Histologic Type, Lymphoma, Hematologic Neoplasms, Immunotherapy, Advanced Cancer
- Keywords
- advanced solid tumor, R/R lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Business Decision
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- Oct 2021 (estimated)
- First posted
- 26 Oct 2018 (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.
SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The study drug will be administered by intravenous infusion.
Detailed description
SHR-1603-I-101 is a single-arm, open-label, dose finding, first-in-human(FIH) clinical trial of SHR-1603 intravenous infusion in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases.
The primary objective of this study is to evaluate the safety and tolerability of SHR-1603, as well as to determine the maximally tolerated dose(MTD) and define the recommended Phase 2 dose(RP2D) of SHR-1603.
The study is consisted of a dose-escalation Part 1 followed by a dose expansion Part 2 and a clinical expansion Part 3.
Part 1 will use accelerated titration and 3+3 dose-escalation design to determine MTD.
Part 2 will further evaluate the safety, tolerability and PK/PD features of SHR-1603 based on the results of Part 1.
Part 3 will include several cohorts of malignancies to collect preliminary efficacy information of SHR-1603.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1603 | Experimental | Drug: SHR-1603Multiple escalating doses of SHR-1603 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18 years or older;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Life expectancy no less than 12 weeks;
- Pathologically confirmed advanced solid tumor or relapsed/refractory lymphoma with measurable target lesions;
- Adequate bone marrow, haptic, renal and coagulation function.
Key exclusion criteria (9 listed)
- Evidence of central nervous system (CNS) involvement;
- Previously treated with similar agents;
- History of anticancer treatment within 4 weeks of enrollment (6 weeks for subjects treated with nitrosoureas or mitomycins);
- Anticipated to be involved in other anti-cancer treatments expect for palliative care during the trial;
- History of anti-cancer vaccination; or history of vaccination using attenuated vaccines within 4 weeks of enrollment;
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-1603SHR-1603 monotherapy | Drug | SHR-1603 |
Primary outcome
Adverse events(AE) of SHR-1603
Time frame: 18 months (anticipated)
Assessment of the incidence of treatment-emergent AEs
Dose-limited toxicity (DLT) of SHR-1603
Time frame: 18 months(anticipated)
Assessment of the incidence of DLT
Maximum tolerated dose (MTD) of SHR-1603
Time frame: 18 months(anticipated)
The highest dosing level at which no more than 1 of 6 patients has DLT
11 secondary outcomes
The peak plasma concentration (Cmax) of SHR-1603
Time frame: 18 months (anticipated)
The area under the plasma concentration versus time curve (AUC) of SHR-1603
Time frame: 18 months (anticipated)
The half-life(t1/2) of SHR-1603
Time frame: 18 months (anticipated)
The objective response rate(ORR) in subjects with advanced tumors treated with SHR-1603
Time frame: 36 months
The best of response (BOR) in subjects with advanced tumors treated with SHR-1603
Time frame: 36 months
The progression free survival (PFS) in subjects with advanced tumors treated with SHR-1603
Time frame: 36 months
The Duration of response (DoR) in subjects with advanced tumors treated with SHR-1603
Time frame: 36 months
The disease control rate (DCR) in subjects with advanced tumors treated with SHR-1603
Time frame: 36 months
The clinical benefit rate (CBR) in subjects with advanced tumors treated with SHR-1603
Time frame: 36 months
SHR-1603 receptor occupation
Time frame: 30 months
SHR-1603 antibodies
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
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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.
1 site 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-1603 in people with Physiological Effects of Drugs and Neoplasms by Histologic Type, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 5 inclusion and 9 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: paused, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
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(AE) of SHR-1603 (time frame: 18 months (anticipated)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2021.