AzTrials
AzTrials

Advanced Solid MalignanciesPhase 1NCT04353102

A Study to Evaluate the Safety, Tolerability and How YH002 Enters, Moves Through and Exits the Body in Subjects With Advanced Solid Malignancies

A Phase 1 study testing YH002 in people with Advanced Solid Malignancies, 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
Search all trials

Trial summary

This is an open-label, dose-escalation study of the study drug YH002. The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of YH002 in patients with advanced solid Malignancies Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Malignancies
What is being tested?
YH002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesAustralia
Study dates
22 Apr 2020to 24 Nov 2021
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
  • Confirmed as histologically or cytologically, locally advanced or metastatic non-resectable solid tumors, must have received and progressed on, or been ineligible for, or intolerant of available standard therapies known to confer clinical benefit or for whom no standard therapy exits
  • Subjects enrolled in Dose D, Dose E, Dose F, Dose G, and Dose H cohorts must have at least one measurable lesion per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 and life expectancy no less than 3 months
  • Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy, lymphopenia, and endocrinopathies controlled with hormone replacement therapy

Who cannot join

  • Symptomatic central nervous system (CNS) metastases. Subjects with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS- directed therapy, and do not require corticosteroids or anticonvulsants are eligible for study entry
  • Received anticancer therapy or radiation therapy within 5 half-lives or 4 weeks prior to study entry, whichever is shorter
  • Received palliative radiotherapy to a single area of metastasis within 2 weeks prior to study entry
  • Received agonist antibodies to TNFR such as anti-CD137, OX40, CD27 and CD357 antibodies prior to the study entry
  • Allergy or sensitivity to YH002, or known allergies to antibodies produced from Chinese hamster ovary cells which assessed to increase the potential for an adverse hypersensitivity to YH002 by Investigator
  • History of a Grade 3-4 allergic reaction to treatment with another monoclonal antibody
Show all 11Show fewer
  • Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy. Hypothyroidism, Type 1 DM, and dermatologic irAEs (except previous Steven Johnson Syndrome, toxic epidermal necrolysis, or other severe forms of dermatitis). Type 1 DM should be controlled with reduction of toxicity to Grade 1 or less
  • Concomitant active autoimmune disease or history of autoimmune disease requiring systemic treatment or history of autoimmune disease within 2 years prior to study entry (except vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus or hypothyroidism which can be managed by replacement therapy)
  • Received steroids or other immunosuppressive systemic therapy within 4 weeks prior to the first dose of the study drug, or has need to be treated during the study (except using on low systemic absorption location prevent or treat non- autoimmune condition)
  • Active hepatitis B or C. Hepatitis B carriers without active disease or cured Hepatitis C may be enrolled
  • Severe cardiovascular disease within 6 months of study entry

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • St George Private Hospital

    Kogarah, New South Wales, 2217

  • Macquarie University

    Macquarie, New South Wales, 2162

Other trials in Australia

About this study

Official title: A First-in-Human (FIH), Multicenter, Open-Label, Phase 1 Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of YH002 in Subjects With Advanced Solid Malignancies

This is an open-label, dose-escalation study of the study drug YH002. The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of YH002 in patients with advanced solid Malignancies

Read the detailed description

This is a single arm clinical trial in subjects with advanced solid tumor receiving multiple doses of YH002 intravenously (IV). YH002 will be administered (IV) in 6-48 patients with advanced solid tumors. An accelerated titration method followed by a traditional 3+3 dose escalation algorithm will be utilized to determine MTD/MAD. Patients will be dosed at Dose A, Dose B, Dose C, Dose D, Dose E, Dose F, Dose G, and Dose H every 3 weeks (Q3W).

Being tested
YH002
Keywords
dose escalation, safety, tolerability, advanced solid malignancie, pharmacokinetics

What participants receive

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

  • YH002Drug

    YH002 will be administered intravenously every three weeks (Q3W) for up to 2 years at doses of Dose A, Dose B, Dose C, Dose D, Dose E, Dose F, Dose G, and Dose H.

Study groups in NCT04353102
Study groupRoleWhat they receive
YH002ExperimentalAll subject will receive YH002 intravenously as single agent every three weeks (Q3W) for up to 2 years, until intolerable toxicity, confirmed disease progression, withdrawal of consent, or Investigator decision, whichever comes first. Subjects who remain on treatment in the absence of disease progression for more than 2 years may continue to receive study drug through a single patient IND.
Receives: Drug: YH002

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 YH002 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 2 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: Cycle 1 of each cohort. Duration of one cycle is 3 weeks

  3. Dose-limiting toxicities (DLT)

    DLT is defined as a toxicity (adverse event at least possibly related to YH002) occurring during the DLT observation period (the initial 21 days)

    Measured: Cycle 1 of each cohort. Duration of one cycle is 3 weeks

Secondary outcomes (17)

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

    To determine the pharmacokinetics (PK) profile of YH002

    Measured: Up to 2 years

  2. Volume of distribution (Vd)

    To determine the pharmacokinetics (PK) profile of YH002

    Measured: Up to 2 years

  3. Volume of distribution at steady state (Vss)

    To determine the pharmacokinetics (PK) profile of YH002

    Measured: Up to 2 years

  4. Maximum serum concentration (Cmax)

    To determine the PK profile of YH002 as single agent

    Measured: Up to 2 years

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

    To determine the PK profile of YH002

    Measured: Up to 2 years

  6. Time to reach maximum serum concentration (Tmax)

    To determine the PK profile of YH002

    Measured: Up to 2 years

  7. Clearance (CL)

    To determine the PK profile of YH002

    Measured: Up to 2 years

  8. Terminal half-life (T1/2)

    To determine the PK profile of YH002

    Measured: Up to 2 years

  9. Dose proportionality

    To determine the PK profile of YH002

    Measured: Up to 2 years

  10. Incidence of anti-drug antibodies (ADAs)

    To assess the immunogenicity of YH002

    Measured: Up to 2 years

  11. Incidence of neutralizing antibodies (NAbs)

    To assess the immunogenicity of YH002

    Measured: Up to 2 years

  12. Objective response rate (ORR)

    To assess the preliminary antitumor activity of YH002

    Measured: Up to 2 years

  13. Duration of response (DOR)

    To assess the preliminary antitumor activity of YH002

    Measured: Up to 2 years

  14. Progression free survival (PFS)

    To assess the preliminary antitumor activity of YH002

    Measured: Up to 2 years

  15. Time to response (TTR)

    To assess the preliminary antitumor activity of YH002

    Measured: Up to 2 years

  16. Disease control rate (DCR)

    To assess the preliminary antitumor activity of YH002

    Measured: Up to 2 years

  17. Duration of disease control (DOC)

    To assess the preliminary antitumor activity of YH002

    Measured: Up to 2 years

Timeline

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

  1. First posted20 Apr 2020
  2. Study start22 Apr 2020
  3. Primary completion14 Sep 2021
  4. Study completion24 Nov 2021

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353102
Sponsor's protocol ID
YH002002
Status last verified
Jul 2022
First submitted
17 Apr 2020
Last updated
22 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YH002 in people with Advanced Solid Malignancies, 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 5 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 22 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 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 2 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 NCT04353102.

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 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in