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Advanced Solid TumorsPhase 1NCT03133247

A Trial to Evaluate Safety and Tolerability of SHR-1316 in Cancer Patients

A Phase 1 study testing SHR-1316 in people with Advanced Solid Tumors, run by Atridia Pty Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In many types of human tumors, PD-L1 is highly expressed. Such high expression has often been associated with poor prognosis in cancer patients. SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SHR-1316
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteAustralia
Study dates
1 Jun 2017to 5 Jul 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible to participate in this study, each subject must meet all of the following criteria:
  • Male or female ≥18 years of age;
  • Diagnosed (histologically or cytologically) with solid tumors and documented as advanced or metastatic disease for which there is no known effective anti-tumor treatment (refractory to or relapsed from standard therapies). Subjects must have confirmation of this diagnosis through study-site analysis of fresh or archived tissue;
  • Failed no more than 1 prior PD-1/PD-L1 therapy and that more than 4 weeks has elapsed.
  • No prior cancer therapy within last 4 weeks;
  • ECOG Performance Status of 0 or 1 at both the screening and baseline visits;
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  • Life expectancy ≥12 weeks;
  • Adequate laboratory parameters during screening as evidenced by:
  • Absolute neutrophil count ≥1.5×109/L (1500/mm3)
  • Platelets ≥100×109/L (100,000/mm3)
  • Hemoglobin (Hgb) ≥9.0 g/dL (90 g/L)
  • Albumin levels ≥2.8 g/dL
  • Total bilirubin ≤1.5 times the upper limit of normal (× ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN; for subjects with liver metastases, ALT and AST ≤5× ULN
  • Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (using Cockcroft-Gault equation)
  • Female subjects agree not to be pregnant or lactating from beginning of the study screening to 3 months after receiving the last treatment:
  • Both men and women of reproductive potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy
  • A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly
  • Willing and able to comply with clinic visits and study-related procedures;
  • Provide signed informed consent.

Who cannot join

  • Subjects who fulfill any of the following criteria at screening will be ineligible to participate in this study:
  • Known history of hypersensitivity to any components of the SHR-1316 product;
  • Any investigational or concurrent cancer therapy (including surgery, radiotherapy, immunotherapy, hormone therapy, or target therapy), administered within 4 weeks or 5 half-lives, whichever is longer, before the first dose of SHR-1316; or within 6 weeks in the case of certain therapies (e.g., extensive radiotherapy, major surgery, mitomycin C and nitrosoureas). Any such, prior systemic therapy needs to be outside of five half-lives, unless discussed and explained with the sponsor. Any AEs from prior therapy must have returned to ≤ Grade 1 CTCAE level;
  • Subjects with active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid patients with a history of Grave's disease (subjects with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study drug), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease. Prior treated brain or meningeal metastases must be clinically stable (MRI) for at least 8 weeks and off immunosuppressive doses of systemic steroids (<10 mg/day prednisone or equivalent) for at least 4 weeks before study drug administration;
  • Clinically significant cardiovascular condition, including: (1) history of congestive heart failure (NYHA Class >2), (2) history of unstable angina, (3) myocardial infarction within the past 12 months, or (4) history of supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
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  • History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful:
  • For example, a screening QTcF interval that is prolonged (>450 milliseconds [msec] in males; >470 msec in females).
  • Active infection or an unexplained fever >38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled);
  • History of immunodeficiency including seropositivity 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);
  • Any other medical (e.g., pulmonary, metabolic, congenital, endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Linear Clinical Research

    Perth, Western Australia

Other trials in Australia

About this study

Official title: A Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Solid Tumors

In many types of human tumors, PD-L1 is highly expressed. Such high expression has often been associated with poor prognosis in cancer patients. SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.

Read the detailed description

This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase I study of repeated doses of SHR-1316 in subjects with advanced or metastatic solid tumors who have failed current standard anti-tumor therapies.

Being tested
SHR-1316

What participants receive

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

  • SHR-1316Drug

    Also called HTI-1088

    PD-L1

Study groups in NCT03133247
Study groupRoleWhat they receive
SHR-1316 dose-escalationExperimentalSHR-1316 doses will be escalated sequentially in 5 cohorts.
Receives: Drug: SHR-1316

What is being measured

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

  1. Adverse events (AEs)

    Incidence of treatment-related AEs

    Measured: Up to 3 weeks

  2. Laboratory parameters

    Incidence of clinically significant laboratory abnormalities

    Measured: Up to 3 weeks

  3. Vital sign values

    Incidence of clinically significant vital sign abnormalities

    Measured: Up to 3 weeks

  4. ECG values

    Incidence of clinically significant ECG abnormalities

    Measured: Up to 3 weeks

  5. Dose-limiting toxicities (DLTs)

    Number of participants with DLTs

    Measured: Up to 3 weeks

Secondary outcomes (6)

  1. Tmax

    Time to maximum plasma concentration

    Measured: Cycle 1 Day 1 (pre-dose and 5 min, 1 hr, 2 hr, and 6 hr post-dose), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22; Day 1 from Cycle 2 onwards (pre-dose and 5-min post-dose)

  2. Cmax

    Maximum plasma drug concentration

    Measured: Cycle 1 Day 1 (pre-dose and 5 min, 1 hr, 2 hr, and 6 hr post-dose), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22; Day 1 from Cycle 2 onwards (pre-dose and 5-min post-dose)

  3. AUC

    Area under the time-concentration curve

    Measured: Cycle 1 Day 1 (pre-dose and 5 min, 1 hr, 2 hr, and 6 hr post-dose), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22; Day 1 from Cycle 2 onwards (pre-dose and 5-min post-dose)

  4. t1/2

    Observed terminal half-life

    Measured: Cycle 1 Day 1 (pre-dose and 5 min, 1 hr, 2 hr, and 6 hr post-dose), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22; Day 1 from Cycle 2 onwards (pre-dose and 5-min post-dose)

  5. Receptor occupancy

    PD-1 receptor occupancy in blood

    Measured: Cycle 1 Day 1 (pre-dose, 1 hr post-dose); Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1

  6. Immunogenicity

    Incidence of anti-SHR-1316 antibodies

    Measured: Cycle 1 Day 1 (pre-dose), Cycle 1 Day 8, Cycle 1 Day 15; pre-dose on Day 1 of Cycle 2 onwards

Timeline

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

  1. First posted28 Apr 2017
  2. Study start1 Jun 2017
  3. Primary completion9 Apr 2019
  4. Study completion5 Jul 2019

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03133247
Sponsor's protocol ID
SHR1316-002
Status last verified
Jul 2022
First submitted
8 Apr 2017
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1316 in people with Advanced Solid Tumors, run by Atridia Pty Ltd. at 1 site in Australia.

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 20 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: finished, as of the sponsor's last update on 12 Jul 2022. 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 Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse events (AEs) (time frame: Up to 3 weeks). The study lists 5 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 NCT03133247.

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 12 Jul 2022.

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