CClinicalTrials.gg
Status unknownNCT03601598Updated Jul 26, 2018

A Trial of SHR-1210 in Combination With SHR6390 in Patients With Advanced CRC, NSCLC and HCC

A Phase 1/2 interventional study of SHR-1210 and SHR6390 in CRC, HCC and NSCLC, sponsored by Harbin Medical University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by Harbin Medical University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • CRC
  • HCC
  • NSCLC
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In context

Lead sponsor

Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (estimated)

Study arms

  • Experimental
    SHR-1210 + SHR6390

    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

    Drug: SHR-1210 · Drug: SHR6390

Interventions

  • DrugSHR-1210

    SHR-1210 was administered 200mg iv every 2 weeks

  • DrugSHR6390

    SHR6390 was administered 150mg or 100mg oral daily with 3 weeks on and 1 week off

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What researchers measure

Primary outcomes

  1. MTD /DLT (phase Ib)

    Maximum Tolerated Dose/Dose Limiting Toxicity

    Time frame: Within four weeks after dosing

  2. ORR(phase II)

    Overall Response Rate

    Time frame: from the first drug administration up to two years

Secondary outcomes

  1. ORR(phase Ib)

    Overall Response Rate

    Time frame: from the first drug administration up to two years

  2. Incidence of Treatment-Emergent Adverse Events (phase Ib/II)

    adverse events/serious adverse events

    Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose

  3. CBR (phase Ib/II)

    Clinical Benefit Rate

    Time frame: from the first drug administration up to last patients treatment for 6 months.

  4. DoR (phase Ib/II)

    Duration of response

    Time frame: from the first drug administration up to two years

  5. PFS(phase Ib/II)

    Progression-Free-Survival

    Time frame: from the first drug administration up to two years

  6. TTR(phase Ib/II)

    Time to Response

    Time frame: from the first drug administration up to one year

  7. 12m-OS

    12 months Overall survival

    Time frame: 12 months after the first drug administration

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03601598
Lead sponsor
Harbin Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Yanqiao Zhang (Director of the hospital, Harbin Medical University) — Principal investigator
First posted
Jul 26, 2018
Start date
Jul 30, 2018 (estimated)
Primary completion
Jul 30, 2019 (estimated)
Completion
Jul 30, 2020 (estimated)
Last update
Jul 26, 2018

Study contacts

Yanqiao Zhang, PhD
Contact
yanqiaozhang@126.com
138 4512 0210
Guangyu Wang, PhD
Contact
18249038966@163.com
18249038966
Yanqiao Zhang, PhD
principal investigator · Harbin Medical University Cancer Hosptital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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