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Solid TumorPhase 1NCT03710265

SHR-1701 in 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 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 Phase I study is to access the safety and tolerability of SHR-1701 at different dose levels. It is hoped to find out the recommended dose for Phase II/III. 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
206 participants
Where
1 siteChina
Study dates
20 Nov 2018to 31 Dec 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

  • Male or female subjects aged between 18 and 75 years
  • Life expectancy >= 12 weeks as judged by the Investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Has measurable disease per RECIST 1.1
  • Subjects with confirmed metastatic or locally advanced solid tumor (histologically or cytologically) and there is no known effective anti-tumor treatment (refractory or relapsed from standard treatment).
  • Adequate hematological, hepatic and renal function as defined in the protocol
  • Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.
  • Able to understand and sign an informed consent, and able to comply with all procedures

Who cannot join

  • Anticancer treatment within 28 days before the first dose of study drug
  • Major surgery within 28 days before start of trial treatment (prior diagnostic biopsy is permitted)
  • 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, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded
  • Subjects with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded
  • Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.
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  • History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy, e.g., hepatitis B or C
  • 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

Trial locations and contacts

1 site in 1 country.

Linna Wang, MD contact

+86-10-67166319

Linna.wang@hengrui.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Lin Shen, MD

    Recruiting

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 and Expansion to Selected Indications

The main purpose of this Phase I study is to access the safety and tolerability of SHR-1701 at different dose levels. It is hoped to find out the recommended dose for Phase II/III.

Read the detailed description

This is a Phase I, open-label trial in patients with metastatic or locally advanced solid tumor. There are three parts of the study: a dose-escalation part, a dose-expansion part, and a clinical expansion part. Dose escalation part is a standard "3+3" cohort design, for which 3 or 6 subjects will be enrolled at each dose level depending on the occurrence of dose-limiting toxicities (DLTs). Dose-expansion means that at least 10 subjects (included subjects of the dose-escalation part) will be selected in 2 - 3 dose levels to focus on the pharmacokinetics (PK) / pharmacodynamic (PD) features. After determination of the recommended dose for Phase II (RP2D), clinical expansion will be opened. Many more subjects will be invited to take part in the study and received the study drug at the RP2D. Additional purpose of the study is to find out whether the study drug has anti-tumor effects.

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 dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Study groups in NCT03710265
Study groupRoleWhat they receive
SHR-1701ExperimentalNot described
Receives: Drug: SHR-1701

What is being measured

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

  1. Safety and tolerability profile of SHR-1701

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

    Measured: Up to week 3

  2. Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1

    Measured: Screening up to study completion, an average of 1 year

Secondary outcomes (15)

  1. Area under the plasma concentration versus time curve (AUC) of SHR-1701

    Measured: Up to 4 weeks after last treatment

  2. Peak Plasma Concentration (Cmax) of SHR-1701

    Measured: Up to 4 weeks after last treatment

  3. Half-time (t1/2) of SHR-1701

    Measured: Up to 4 weeks after last treatment

  4. Pharmacodynamic features of SHR-1701

    SHR-1701 receptor occupation

    Measured: 12 months (anticipated)

  5. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ¡Ý30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

    Measured: 12 months (anticipated)

  6. Disease Control Rate (DCR) per RECIST 1.1

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

    Measured: 12 months (anticipated)

  7. Best Overall Response (BOR) per RECIST 1.1

    Measured: 12 months (anticipated)

  8. Immunogenicity of SHR-1701

    anti SHR-1603 antibodies (ADA)

    Measured: 12 months (anticipated)

  9. Trough plasma concentration (C trough) of SHR-1701

    Measured: Up to 4 weeks after last treatment

  10. Immunogenicity of SHR-1701

    Measured: 12 months (anticipated)

  11. Disease Control Rate (DCR) per RECIST 1.1

    Measured: 12 months (anticipated)

  12. Clinical Benefit Rate(CBR) per RECIST 1.1

    Measured: 12 months (anticipated)

  13. Progression-Free Survival (PFS) per RECIST 1.1

    Measured: 12 months (anticipated)

  14. Duration of Response (DoR) per RECIST 1.1

    Measured: 12 months (anticipated)

  15. Overall Survival (OS)

    Measured: 12 months (anticipated)

Timeline

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

  1. First posted18 Oct 2018
  2. Study start20 Nov 2018
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (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
206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03710265
Sponsor's protocol ID
SHR-1701-I-101
Status last verified
Nov 2021
First submitted
14 Oct 2018
Last updated
22 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peng H, Jiang L, Yuan J, Wu X, Chen N, Liu D, Liang Y, Xie Y, Jia K, Li Y, Feng X, Li J, Zhang X, Shen L, Chen Y. Single-cell characterization of differentiation trajectories and drug resistance features in gastric cancer with peritoneal metastasis. Clin Transl Med. 2024 Oct;14(10):e70054. doi: 10.1002/ctm2.70054.

    PubMed 39422697

  • Liu D, Zhou J, Wang Y, Li M, Jiang H, Liu Y, Yin X, Ge M, Xiang X, Ying J, Huang J, Zhang YQ, Cheng Y, Huang Z, Yuan X, Han W, Yan D, Wang X, Liu P, Wang L, Zhang X, Luo S, Liu T, Shen L. Bifunctional anti-PD-L1/TGF-betaRII agent SHR-1701 in advanced solid tumors: a dose-escalation, dose-expansion, and clinical-expansion phase 1 trial. BMC Med. 2022 Oct 25;20(1):408. doi: 10.1186/s12916-022-02605-9.

    PubMed 36280870

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 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 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: status not confirmed, as of the sponsor's last update on 22 Nov 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?

Contact Linna Wang, MD (+86-10-67166319, Linna.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability profile of SHR-1701 (time frame: Up to week 3). 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 NCT03710265, which also lists 2 linked publications.

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 Nov 2021.

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Clinical Trial NCT03710265 | AzTrials