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Advanced Solid TumorPhase 1NCT04357756

A Study to Assess YH001 in Combination With Toripalimab Injection in Subjects With Advanced Solid Tumors

A Phase 1 study testing YH001 and Toripalimab in people with Advanced Solid Tumor, run by Eucure (Beijing) Biopharma Co., Ltd at 3 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, dose-escalation study of YH001 administered intravenously (IV) in combination with Toripalimab. The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of YH001 when administered in combination with Toripalimab to subjects… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
YH001 and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
3 sitesAustralia
Study dates
21 Apr 2020to 19 Oct 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged ≥ 18 years
  • Have advanced histologically or cytologically confirmed solid tumor
  • Have progressed on after treatment with standard therapies or intolerant of standard care
  • At least 1 unidimensional measurable target lesion per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
  • Have life expectancy of at least 12 weeks based on investigator's judgement

Who cannot join

  • Treated with any investigational drug within 4 weeks prior to the fist dose of study drug
  • Received any anticancer therapy less than 28 days prior to the first administration of study drug or within 5 half-lives of the therapy agent, whichever is shorter. Prior palliative radiotherapy to bone metastases ≤ 2 weeks prior to the first dose of YH001 is acceptable
  • Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded
  • Subjects with prior PD-1/L1 treatment intolerate to PD-1/L1 therapy should be excluded
  • Subjects with a history of ≥ Grade 3 immune-related adverse events (AEs) resulted from previous immunotherapy or an AE of any grade that resulted in discontinuation of prior immunotherapy
  • Subjects with a history of ≥ Grade 2 pneumonitis resulted from previous immunotherapy or with a SpO2 by pulse oximetry < 92% at the screening
Show all 11Show fewer
  • Subjects requiring systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 21 days before the planned first dose of study drug or has need to be treated while on trial. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Ophthalmologic, nasal and intra-articular injections of steroids are allowed
  • Subjects with concomitant active autoimmune disease, history of autoimmune disease requiring systemic treatment, or history of autoimmune disease within the two years prior to study entry. Exceptions are subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus or hypothyroidism which can be managed by replacement therapy
  • Primary central nervous system (CNS) malignancies or symptomatic CNS metastases. But subjects with asymptomatic CNS metastases might be eligible if they have no clinical evidence of progression since completion of CNS-directed therapy, minimum 4 weeks between completion of radiotherapy and the first dose of YH001 and are currently not receiving corticosteroids
  • QTc > 450 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome
  • Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ Grade 1 per CTCAE v5.0, except alopecia, < Grade 2 sensory neuropathy

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • Blacktown Hospital, Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, 2148

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • St George Private Hospital

    Kogarah, New South Wales, 2217

Other trials in Australia

About this study

Official title: A First-in-human (FIH), Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of YH001 in Combination With Toripalimab Injection in Subjects With Advanced Solid Tumors

This is an open-label, dose-escalation study of YH001 administered intravenously (IV) in combination with Toripalimab. The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of YH001 when administered in combination with Toripalimab to subjects with advanced solid tumors.

Read the detailed description

This trial will have a run-in phase to explore the safety and tolerability of YH001 as a single agent for 21 days as DLT observation period then followed by a combination phase to further explore the safety and tolerability of YH001 combined with Toripalimab (anti-PD-1 antibody) for each dose level during dose escalation.

The dose escalation will follow the traditional "3 + 3" dose escalation scheme. These subjects will be treated with YH001 and Toripalimab. YH001 will be administered intravenously every three weeks (Q3W) for 15 weeks (5 cycles) at doses of Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G. Toripalimab will be administered by IV (Q3W) by the fixed dose of 240 mg from the 2nd cycle to 5th cycle. A single subject will be enrolled at Dose A as starting dose of YH001, and subsequent cohort will be expanded to include 3-6 subjects.

Being tested
YH001, Toripalimab
Keywords
dose escalation, safety, tolerability, advanced solid tumors, pharmacokinetics

What participants receive

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

  • YH001Drug

    YH001 will be administered intravenously every three weeks (Q3W) for 15 weeks (5 cycles) at doses of Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G.

  • ToripalimabDrug

    Toripalimab will be administered by intravenously (Q3W) by the fixed dose of 240 mg from the 2nd cycle to 5th cycle.

Study groups in NCT04357756
Study groupRoleWhat they receive
YH001 combined with ToripalimabExperimentalAll the patients will receive YH001 intravenously as single agent for 21 days followed by combination phase.
Receives: Drug: YH001; Drug: Toripalimab

What is being measured

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

  1. Number of participants with adverse events and serious adverse events

    The safety profile of YH001 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: From screening up to 1 year

  2. Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycle

    Measured: During Cycle 1 (each cycle is 21 days)

  3. Dose-limiting toxicities (DLT)

    DLT is defined as a toxicity (adverse event at least possibly related to YH001) occurring during the DLT observation period (the initial 21 days) both in run-in phase of YH001 as single agent and in combination phase of YH001 in combination with Toripalimab

    Measured: During Cycle 1 (each cycle is 21 days)

Secondary outcomes (18)

  1. Area under the serum concentration versus time curve within one dosing interval (AUCtau)

    To determine the PK profile of YH001 alone and in combination with Toripalimab

    Measured: Up to 1 year

  2. Steady state AUC

    To determine the PK profile of YH001 alone and in combination with Toripalimab

    Measured: Up to 1 year

  3. Maximum serum concentration (Cmax)

    To determine the PK profile of YH001 alone and in combination with Toripalimab

    Measured: Up to 1 year

  4. Trough concentration before the next dose is administered (Ctrough)

    To determine the PK profile of YH001 alone and in combination with Toripalimab

    Measured: Up to 1 year

  5. Time to reach maximum serum concentration (Tmax)

    To determine the PK profile of YH001 alone and in combination with Toripalimab

    Measured: Up to 1 year

  6. Clearance (CL)

    To determine the PK profile of YH001 alone and in combination with Toripalimab

    Measured: Up to 1 year

  7. Volume of distribution (Vd)

    To determine the PK profile of YH001 alone and in combination with Toripalimab

    Measured: Up to 1 year

  8. Terminal half-life (T1/2)

    To determine the PK profile of YH001 alone and in combination with Toripalimab

    Measured: Up to 1 year

  9. Dose proportionality

    To determine the PK profile of YH001 alone and in combination with Toripalimab

    Measured: Up to 1 year

  10. Incidence of anti-drug antibodies (ADAs)

    To assess the immunogenicity of YH001 in combination with Toripalimab

    Measured: Up to 1 year

  11. Incidence of neutralizing antibodies (NAbs)

    To assess the immunogenicity of YH001 in combination with Toripalimab

    Measured: Up to 1 year

  12. Objective response rate (ORR)

    To assess the preliminary antitumor activity of YH001 in combination with Toripalimab

    Measured: Up to 1 year

  13. Duration of response (DOR)

    To assess the preliminary antitumor activity of YH001 in combination with Toripalimab

    Measured: Up to 1 year

  14. Time to response (TTR)

    To assess the preliminary antitumor activity of YH001 in combination with Toripalimab

    Measured: Up to 1 year

  15. Progression free survival (PFS)

    To assess the preliminary antitumor activity of YH001 in combination with Toripalimab

    Measured: Up to 1 year

  16. Overall survival (OS)

    To assess the preliminary antitumor activity of YH001 in combination with Toripalimab

    Measured: Up to 1 year

  17. Disease control rate (DCR)

    To assess the preliminary antitumor activity of YH001 in combination with Toripalimab

    Measured: Up to 1 year

  18. Duration of disease control (DDC)

    To assess the preliminary antitumor activity of YH001 in combination with Toripalimab

    Measured: Up to 1 year

Timeline

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

  1. First posted22 Apr 2020
  2. Study start21 Apr 2020
  3. Primary completion19 Oct 2022
  4. Study completion19 Oct 2022

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04357756
Sponsor's protocol ID
YH001002
Status last verified
Sep 2023
First submitted
17 Apr 2020
Last updated
13 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YH001 and Toripalimab in people with Advanced Solid Tumor, run by Eucure (Beijing) Biopharma Co., Ltd at 3 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 6 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 and serious adverse events (time frame: From screening up to 1 year). The study lists 3 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 NCT04357756.

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 13 Sep 2023.

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