CRCPhase 1/2NCT03601598
A Trial of SHR-1210 in Combination With SHR6390 in Patients With Advanced CRC, NSCLC and HCC
A Phase 1/2 study testing SHR-1210 and SHR6390 in people with CRC and HCC, run by Harbin Medical University.
Trial summary
This is a Phase Ib/II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With SHR6390 (a CDK4/6 Inhibitor) in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- SHR-1210 and SHR6390
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2018to 30 Jul 2020
- Phase
- Phase 1/2
- 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
- Subjects voluntarily participate in this study and sign informed consent .
- Men or women aged 18-75 years
- Has confirmed by histology and cytology advanced and/or metastatic colorectal cancer patients, the advanced (Ⅲ B/Ⅳ period) in non-small cell lung cancer，Or patients with advanced hepatocellular carcinoma confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
- The patients can swallow pills normally.
- ECOG score was 0 or 1.
- Have a life expectancy of at least 12 weeks.
- The functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L, Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN, ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN
- Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
Who cannot join
- Subjects had any active autoimmune disease or history of autoimmune disease.
- Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- The subjects had a central nervous system metastases of clinical symptoms.
- Central lung squamous cell carcinoma, or NSCLC with large vascular invasion confirmed by imaging.
- A heart condition or disease that is not well controlled.
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- Subjects had active infections.
- Other clinical trials of drugs were used within 4 weeks prior to the first administration.
- The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 or CDK4/6 inhibitor treatment in the past.
- There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase Ib/II , Open-label , Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With A CDK4/6 Inhibitor SHR6390 in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and Hepatocellular Carcinoma
This is a Phase Ib/II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With SHR6390 (a CDK4/6 Inhibitor) in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and Hepatocellular Carcinoma.
The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.
Read more
The first part of the study is the Dose-finding Phase designed to establish the safety of SHR-1210 Combination With SHR6390 at different dose Levels(150mg QD or 100mg QD ). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .
This study aims to evaluate the safety and efficacy of SHR-1210 combination with SHR6390 in the treatment of advanced CRC,NSCLC and HCC.
- Being tested
- SHR-1210, SHR6390
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Drug
SHR-1210 was administered 200mg iv every 2 weeks
SHR6390Drug
SHR6390 was administered 150mg or 100mg oral daily with 3 weeks on and 1 week off
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 + SHR6390 | Experimental | SHR-1210 was administered 200mg iv every 2 weeks in combination with SHR6390 150mg or 100mg oral daily with 3 weeks on and 1 week off Receives: Drug: SHR-1210; Drug: SHR6390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD /DLT (phase Ib)
Maximum Tolerated Dose/Dose Limiting Toxicity
Measured: Within four weeks after dosing
ORR(phase II)
Overall Response Rate
Measured: from the first drug administration up to two years
Secondary outcomes (7)
ORR(phase Ib)
Overall Response Rate
Measured: from the first drug administration up to two years
Incidence of Treatment-Emergent Adverse Events (phase Ib/II)
adverse events/serious adverse events
Measured: from the first drug administration to within 90 days for the last SHR-1210 dose
CBR (phase Ib/II)
Clinical Benefit Rate
Measured: from the first drug administration up to last patients treatment for 6 months.
DoR (phase Ib/II)
Duration of response
Measured: from the first drug administration up to two years
PFS(phase Ib/II)
Progression-Free-Survival
Measured: from the first drug administration up to two years
TTR(phase Ib/II)
Time to Response
Measured: from the first drug administration up to one year
12m-OS
12 months Overall survival
Measured: 12 months after the first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start30 Jul 2018 (estimated)
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Yanqiao Zhang, Harbin Medical University
- Investigators
- Yanqiao Zhang, PhD, Principal investigator, Harbin Medical University Cancer Hosptital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601598
- Sponsor's protocol ID
- SHR-1210-SHR6390-IIT
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 26 Jul 2018
- 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 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II , Open-label , Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With A CDK4/6 Inhibitor SHR6390 in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03601598
- Acronym / sponsor ID
- SHR-1210-SHR6390-IIT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 30 Jul 2018 (estimated)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 26 Jul 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.
This is a Phase Ib/II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With SHR6390 (a CDK4/6 Inhibitor) in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and Hepatocellular Carcinoma.
The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.
The first part of the study is the Dose-finding Phase designed to establish the safety of SHR-1210 Combination With SHR6390 at different dose Levels(150mg QD or 100mg QD ). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .
This study aims to evaluate the safety and efficacy of SHR-1210 combination with SHR6390 in the treatment of advanced CRC,NSCLC and HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1210 + SHR6390 | Experimental | Drug: SHR-1210, Drug: SHR6390SHR-1210 was administered 200mg iv every 2 weeks in combination with SHR6390 150mg or 100mg oral daily with 3 weeks on and 1 week off |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate in this study and sign informed consent .
- Men or women aged 18-75 years
- Has confirmed by histology and cytology advanced and/or metastatic colorectal cancer patients, the advanced (Ⅲ B/Ⅳ period) in non-small cell lung cancer，Or patients with advanced hepatocellular carcinoma confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
- The patients can swallow pills normally.
- ECOG score was 0 or 1.
Key exclusion criteria (10 listed)
- Subjects had any active autoimmune disease or history of autoimmune disease.
- Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- The subjects had a central nervous system metastases of clinical symptoms.
- Central lung squamous cell carcinoma, or NSCLC with large vascular invasion confirmed by imaging.
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-1210SHR-1210 was administered 200mg iv every 2 weeks | Drug | SHR-1210 + SHR6390 |
| SHR6390SHR6390 was administered 150mg or 100mg oral daily with 3 weeks on and 1 week off | Drug | SHR-1210 + SHR6390 |
Primary outcome
MTD /DLT (phase Ib)
Time frame: Within four weeks after dosing
Maximum Tolerated Dose/Dose Limiting Toxicity
ORR(phase II)
Time frame: from the first drug administration up to two years
Overall Response Rate
7 secondary outcomes
ORR(phase Ib)
Time frame: from the first drug administration up to two years
Incidence of Treatment-Emergent Adverse Events (phase Ib/II)
Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose
CBR (phase Ib/II)
Time frame: from the first drug administration up to last patients treatment for 6 months.
DoR (phase Ib/II)
Time frame: from the first drug administration up to two years
PFS(phase Ib/II)
Time frame: from the first drug administration up to two years
TTR(phase Ib/II)
Time frame: from the first drug administration up to one year
12m-OS
Time frame: 12 months after the first drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
Yanqiao Zhang, PhD principal investigator
Harbin Medical University Cancer Hosptital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-1210 and SHR6390 in people with CRC and HCC, run by Harbin Medical University.
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 10 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: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Yanqiao Zhang, PhD (138 4512 0210, yanqiaozhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD /DLT (phase Ib) (time frame: Within four weeks after dosing). The study lists 2 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 26 Jul 2018.