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Solid TumorPhase 1NCT03774979

SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors

A Phase 1 study testing SHR-1701 in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 16 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
SHR-1701
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
16 sitesChina
Study dates
24 Jan 2019to Dec 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to provide signed informed consent form, and able to comply with all procedures.
  • Histologically or cytologically proven metastatic or locally advanced solid tumors.
  • Male or female subjects aged 18-75 years.
  • Life expectancy >= 12 weeks as judged by the Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
  • Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Adequate hematological, hepatic and renal function as defined in the protocol
  • Other protocol-defined inclusion criteria could apply.

Who cannot join

  • Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
  • Anticancer treatment within 28 days before the first dose of study drug.
  • Major surgery within 28 days before start of trial treatment.
  • Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
  • With any active autoimmune disease or history of autoimmune disease.
  • With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
Show all 11Show fewer
  • Clinically significant cardiovascular and cerebrovascular diseases
  • History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
  • Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation
  • Other protocol-defined exclusion criteria could apply

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Beijing Chest Hospital,Capital Medical University-Integrated Department

    Beijing

  • Tumor Hospital of the Chinese Academy of Medical Sciences

    Beijing

  • Cancer Hospital of Hunan Province

    Changsha, Hunan

  • Hunan Cancer Hospital-Gynecologic Oncology

    Changsha, Hunan

  • ChongQing Cancer Hospital-gynecologic oncology

    Chongqing

  • Chongqing Cancer Hospital

    Chongqing

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center

    Guangzhou, Guangzhou

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, Zhejiang

  • Anhui Chest Hospital-Departmen of Tumor Radiotherapy

    Hefei, Anhui

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jangsu Cancer Hospital

    Nanjing, Jiangsu

  • The First Hospital of China Medical University-Department of Oncology

    Shenyang, Liaoning

  • The First Rffiurted Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Xinxiang Central Hospital-Department of Respiratory Physicians

    Xinxiang, Henan

  • The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications

The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.

Read the detailed description

This is a Phase I, open-label, multiple-ascending dose trial. Study consists of dose-escalation part in subjects with metastatic or locally advanced solid tumors, and expansion part with selected indications.

Conditions
Solid Tumor
Being tested
SHR-1701
Keywords
SHR-1701, Solid tumor, Metastatic or locally advanced solid tumors
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • SHR-1701Drug

    Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.

Study groups in NCT03774979
Study groupRoleWhat they receive
SHR-1701Experimentalintravenous infusion
Receives: Drug: SHR-1701

What is being measured

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

  1. Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies.

    Number of Subjects who occurs dose-limiting toxicity (DLTs).

    Measured: Up to 3/4 weeks.

  2. Clinical expansion Part: Objective Response Rate（ORR）

    ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1.

    Measured: Up to 6 weeks

Secondary outcomes (4)

  1. Clinical expansion Part: Safety of SHR-1701

    Number of subjects who occurs treatment-related Adverse Events(AEs）

    Measured: Up to 4 weeks after last treatment

  2. Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1

    DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1.

    Measured: Up to 6 weeks

  3. Clinical expansion Part: Duration of Response （DOR）per RECIST1.1

    DOR is define as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1

    Measured: Up to 6 weeks

  4. Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1

    Measured: 12months (anticipated)

Timeline

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

  1. First posted13 Dec 2018
  2. Study start24 Jan 2019
  3. Primary completionMar 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03774979
Sponsor's protocol ID
SHR-1701-I-102
Status last verified
Jul 2022
First submitted
10 Dec 2018
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1701 in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 16 sites 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: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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?

Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies. (time frame: Up to 3/4 weeks.). 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?

On the ClinicalTrials.gov record for NCT03774979.

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 8 Nov 2022.

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