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Solid Tumors and Hematologic MalignancyPhase 1NCT02492789

A Trial to Evaluate Safety and Tolerability of INCSHR01210 in Cancer Patients

A Phase 1 study testing INCSHR01210 injection in people with Solid Tumors and Hematologic Malignancy, run by Atridia Pty Ltd. at 5 sites 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

This is an open-label, multicenter, non-randomized, dose escalation and tumor-expansion phase I trial to evaluate safety and tolerability of INCSHR01210 in patients with advanced solid tumors. The trial will enroll subjects with advanced solid tumor who have failed current standard anti-tumor therapies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors and Hematologic Malignancy
What is being tested?
INCSHR01210 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
5 sitesAustralia
Study dates
1 Sep 2015to 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

  • Male or female at least 18 years of age;
  • Patients diagnosed with solid tumors histologically or cytologically and documented as advanced or metastatic disease for which there is no known effective anti-tumour treatment (refractory to or relapsed from standard therapies);
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  • Life expectancy ≥ 12 weeks;
  • Patients enrolled to Part 2 Expansion Cohorts:
  • must have measurable lesion(s) according to the RECIST v1.1;
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  • Cohort A (endometrial carcinoma): Subjects diagnosed with histologically confirmed advanced or metastatic endometrial carcinoma (sarcomas and mesenchymal tumors are excluded). Subjects must have relapsed or be refractory to at least 1 prior standard therapy in the metastatic setting, have been intolerant to standard therapies, or have refused standard therapy. In addition, subjects with disease recurrence within 12 months of completion of adjuvant therapy are eligible.
  • Cohort B (thymic carcinoma): Subjects diagnosed with histologically or cytologically confirmed advanced or metastatic thymic carcinoma based on local guidelines.
  • Cohort C (biliary tract carcinoma): Subjects diagnosed with histologically or cytologically confirmed, advanced or metastatic extrahepatic cholangiocarcinoma (carcinoma of the gallbladder or biliary tree) or carcinoma of the ampulla of Vater. Subjects must have relapsed or be refractory to at least 1 prior standard therapy, have been intolerant to standard therapies, or have refused standard therapy.
  • Cohort D (CUP): Subjects diagnosed with CUP based on ESMO guidelines.
  • Adequate laboratory parameters at screening period as evidenced by:
  • Absolute neutrophil count ≥ 1.5×109/L (1,500/mm3)
  • Platelets ≥100×109/L (100,000/mm3)
  • Hemoglobin ≥ 9.0 g/dL (90 g/L)
  • Albumin levels ≥ 2.8 g/dL
  • Total bilirubin ≤ 1.5×ULN
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; for patients with liver metastases, ALT and AST ≤ 5×ULNSerum creatinine ≤ 1.5×ULNAble to understand and sign an informed consent.

Who cannot join

  • Subjects who fulfill any of the following criteria at screening will be ineligible for admission:
  • Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval.
  • Known history of hypersensitivity to any components of the INCSHR01210 formulation.
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of intravenous contrast allergy prophylaxis are allowed.
  • Active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease). Subjects with brain or meningeal metastases that were previously treated must be clinically stable (magnetic resonance imaging at least 4 weeks apart do not show evidence of new or enlarging metastases) and have discontinued immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration.
  • Uncontrolled clinically significant medical condition, including but not limited to the following: (1) congestive heart failure (New York Health Authority Class > 2), (2) unstable angina, (3) myocardial infarction within the past 12 months, or (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention.
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  • Prior systemic chemotherapy (< 6 weeks if chemotherapy including nitrosoureas or mitomycin), radiotherapy, immunotherapy, hormone therapy, surgery or target therapy within 4 weeks before the study drug administration, or any unresolved adverse events > CTCAE Grade 1 (with the exception of any stable chronic toxicities not expected to resolve).
  • 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, or other acquired or congenital immune-deficient disease.
  • Any other medical (eg, pulmonary, metabolic, congenital, endocrinal or CNS disease), 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 would interfere with the interpretation of the results.
  • Investigational therapy administered within 4 weeks before the first dose of INCSHR01210.
  • Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-hepatitis B core antibody.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Blacktown Hospital

    Blacktown

  • Chris O'Brien Life House

    Camperdown

  • Austin Hospital/Olivia Newton-John Cancer Research Institute

    Heidelberg, Victoria

  • Nucleus Network

    Melbourne

  • Linear Clinical Research Limited

    Nedlands

Other trials in Australia

About this study

Official title: An Open-Label, Multicenter, Nonrandomized, Dose-Escalation and Tumor-Expansion Phase 1 Study to Evaluate the Safety and Tolerability of INCSHR01210 (Formerly SHR-1210) in Subjects With Advanced Solid Tumors

This is an open-label, multicenter, non-randomized, dose escalation and tumor-expansion phase I trial to evaluate safety and tolerability of INCSHR01210 in patients with advanced solid tumors. The trial will enroll subjects with advanced solid tumor who have failed current standard anti-tumor therapies.

Being tested
INCSHR01210 injection
Keywords
immunotherapy, solid tumor, PD-1 blockade
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • INCSHR01210 injectionBiological

    Also called SHR-1210, HR-301210

    Part1: INCSHR01210 injection at a dose of 1, 3 or 10 mg/kg is administered every 2 weeks (3+3,q2w, except in the first cycle, in which subjects will be only dosed once on Day 1 for PK samplings and dose limiting toxicity observation). Response is assessed by every 2 cycles (4 weeks each cycle) by using irRECIST.

    Part2: Additional patients (200mg dose cohorts will be enrolled in Part 2, depending on the data outcomes in Part 1, to further explore preliminarily clinical benefits of INCSHR01210 as well as the other objectives of the study.

Study groups in NCT02492789
Study groupRoleWhat they receive
INCSHR01210Experimental3 dose levels are designed in this study.3 to 6 patients (traditional "3+3" design) will be enrolled in each dose cohort. INCSHR01210 injection at each dose level is administered every 2 weeks (q2w, except in the first cycle).
Receives: Biological: INCSHR01210 injection

What is being measured

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

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Recommended phase II doses (RP2D) is 200 mg, and the only dose interval to be tested will be once every 4 weeks (Q4W).

    Measured: 15 months

Secondary outcomes (10)

  1. Pharmacokinetics (PK) profile of INCSHR01210 (Tmax)

    Measured: Day 1 of cycle 1

  2. Maximum tolerated dose (MTD) of INCSHR01210

    Measured: 6 months

  3. Incidence of anti-INCSHR01210 antibody in serum

    Measured: 15 months

  4. PD-1 receptor occupancy

    Measured: 15 months

  5. Duration of response

    Measured: 15 months

  6. Objective response rate

    Measured: 15 months

  7. Time to progression

    Measured: 15 months

  8. Pharmacokinetics (PK) profile of INCSHR01210 (Cmax)

    Measured: Day 1 of cycle 1

  9. Pharmacokinetics (PK) profile of INCSHR01210 (AUC0-28day)

    Measured: Day 28 of cycle 1

  10. Pharmacokinetics (PK) profile of INCSHR01210 (accumulation ratio R)

    Measured: Day 28 of each cycle

Timeline

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

  1. First posted9 Jul 2015 (estimated)
  2. Study start1 Sep 2015
  3. Primary completion1 Mar 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
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02492789
Sponsor's protocol ID
INCSHR1210-101
Status last verified
Sep 2019
First submitted
26 Jun 2015
Last updated
30 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Lickliter JD, Gan HK, Voskoboynik M, Arulananda S, Gao B, Nagrial A, Grimison P, Harrison M, Zou J, Zhang L, Luo S, Lahn M, Kallender H, Mannucci A, Somma C, Woods K, Behren A, Fernandez-Penas P, Millward M, Meniawy T. A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia. Drug Des Devel Ther. 2020 Mar 18;14:1177-1189. doi: 10.2147/DDDT.S243787. eCollection 2020.

    PubMed 32256049

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCSHR01210 injection in people with Solid Tumors and Hematologic Malignancy, run by Atridia Pty Ltd. at 5 sites 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 17 inclusion and 12 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 15 months). 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 NCT02492789, which also lists 1 linked publication.

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 30 Sep 2019.

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