Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT04842630
A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors
A Phase 1 study testing SHR-1916 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a first in human, open-label, dose escalation and expansion Phase 1 study of SHR-1916 in adult patients with locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- SHR-1916
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2021to 1 Nov 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document；
- Aged between 18-75 years old;
- Histologically or cytologically confirmed advanced or metastatic malignant tumor;
- Presence of at least of one measurable lesion in agreement to RECIST criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- Life expectancy >12 weeks;
- Adequate organ performance based on laboratory blood tests;
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Who cannot join
- Patients who have received cytokines (IL-2, IFN-α)as anti-tumor therapy within 6 months before the first dose;
- Previous systemic therapy within 28 days before the first dose;
- Previous therapeutic surgery within 28 days, and diagnostic surgery within 14 days prior to the first dose;
- Received live attenuated vaccine within 28 days before the first dose, or expected to receive live attenuated vaccine during the study treatment period;
- Patients who received systemic immunosuppressive therapy within 14 days before the first dose;
- Patients with known or suspected brain metastasis；
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- Subjects with interstitial pneumonia or interstitial lung disease, with a history of interstitial pneumonia or interstitial lung disease limiting self care ADL or with life-threatening respiratory compromise, with a history of pulmonary fibrosis, lasting pneumonia, drug- or radiation-induced pneumonia, and congenital pneumonia that may otherwise interfere with the judgement of immune-related pulmonary toxicity, or with any evidence of active pneumonia as shown on chest CT scans;
- Patients with history of autoimmune diseases;
- History of immunodeficiency (including HIV infection) or organ transplantation;
- Known active hepatitis B or C infection;
- Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies
This is a first in human, open-label, dose escalation and expansion Phase 1 study of SHR-1916 in adult patients with locally advanced or metastatic solid tumors.
- Being tested
- SHR-1916
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1916Drug
All participants receive SHR-1906 alone
| Study group | Role | What they receive |
|---|---|---|
| SHR-1916 | Experimental | Not described Receives: Drug: SHR-1916 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity (DLT)
Measured: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Measured: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Measured: Up to 8 months
Secondary outcomes (14)
AEs （Adverse Events）
Measured: 30 days after last dose
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-1916
Measured: 30 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-1916
Measured: 30 days after last dose
Minimum observed plasma concentration (Cmin) of SHR-1916
Measured: 30 days after last dose
Time of maximum observed plasma concentration (Tmax) of SHR-1916
Measured: 30 days after last dose
Percentage of NK cell and CD8+ T cell by flow cytometry
Measured: 30 days after last dose
Absolute count values of NK cell and CD8+ T cell by flow cytometry
Measured: 30 days after last dose
Peripheral plasma concentration of sCD25
Measured: 30 days after last dose
Immunogenicity analysis to assess anti-drug antibodies (ADA) to SHR-1916 in human serum
Measured: 30 days after last dose
ORR（Objective Response Rate）
Measured: at the time point of every 9 weeks
DCR（Disease Control Rate）
Measured: at the time point of every 9 weeks
DoR（Duration of Response）
Measured: up to 2 years
PFS（Progression-Free-Survival）
Measured: up to 2 years
12-month-survival Rate
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start8 Apr 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Why it stopped: R\&d strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
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
- NCT04842630
- Sponsor's protocol ID
- SHR-1916-I-101
- Status last verified
- Feb 2024
- First submitted
- 1 Apr 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT04842630
- Acronym / sponsor ID
- SHR-1916-I-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: R\&d strategy adjustment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 13 Apr 2021 (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 first in human, open-label, dose escalation and expansion Phase 1 study of SHR-1916 in adult patients with locally advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1916 | Experimental | Drug: SHR-1916 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to understand and the willingness to sign a written informed consent document；
- Aged between 18-75 years old;
- Histologically or cytologically confirmed advanced or metastatic malignant tumor;
- Presence of at least of one measurable lesion in agreement to RECIST criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
Key exclusion criteria (11 listed)
- Patients who have received cytokines (IL-2, IFN-α)as anti-tumor therapy within 6 months before the first dose;
- Previous systemic therapy within 28 days before the first dose;
- Previous therapeutic surgery within 28 days, and diagnostic surgery within 14 days prior to the first dose;
- Received live attenuated vaccine within 28 days before the first dose, or expected to receive live attenuated vaccine during the study treatment period;
- Patients who received systemic immunosuppressive therapy within 14 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-1916All participants receive SHR-1906 alone | Drug | SHR-1916 |
Primary outcome
Dose Limited Toxicity (DLT)
Time frame: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Time frame: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Time frame: Up to 8 months
14 secondary outcomes
AEs （Adverse Events）
Time frame: 30 days after last dose
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-1916
Time frame: 30 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-1916
Time frame: 30 days after last dose
Minimum observed plasma concentration (Cmin) of SHR-1916
Time frame: 30 days after last dose
Time of maximum observed plasma concentration (Tmax) of SHR-1916
Time frame: 30 days after last dose
Percentage of NK cell and CD8+ T cell by flow cytometry
Time frame: 30 days after last dose
Absolute count values of NK cell and CD8+ T cell by flow cytometry
Time frame: 30 days after last dose
Peripheral plasma concentration of sCD25
Time frame: 30 days after last dose
Immunogenicity analysis to assess anti-drug antibodies (ADA) to SHR-1916 in human serum
Time frame: 30 days after last dose
ORR（Objective Response Rate）
Time frame: at the time point of every 9 weeks
DCR（Disease Control Rate）
Time frame: at the time point of every 9 weeks
DoR（Duration of Response）
Time frame: up to 2 years
PFS（Progression-Free-Survival）
Time frame: up to 2 years
12-month-survival Rate
Time frame: up to 2 years
Results and safety
The study was stopped early (reason given: R\&d strategy adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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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-1916 in people with Unspecified Adult Solid Tumor, Protocol Specific, 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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 9 Feb 2024. 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?
The study was stopped early (reason given: R\&d strategy adjustment). 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?
Dose Limited Toxicity (DLT) (time frame: 21 Days (first cycle)). 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 9 Feb 2024.