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CancerPhase 1NCT03131765

Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid Tumors

A Phase 1 study testing YS-0N-001 in people with Cancer, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 1 site in Singapore.

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

Phase 1 study evaluating the safety and tolerability of YS-ON-001 in patients with advanced solid tumors who have limited available treatment options, and exploratory evaluation of the pharmacological effect and efficacy of YS-ON-001. The study will be conducted in two parts: dose escalation and cohort expansion Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Cancer
What is being tested?
YS-0N-001
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSingapore
Study dates
20 Apr 2017to 16 Dec 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 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Life expectancy ≥ 3 months
  • Patient with histologically or cytologically proven advanced (unresectable) or metastatic solid tumor who have failed standard therapies or are intolerant to standard therapies.Part 1: Any advanced or metastatic solid tumor patient Part 2: Selected tumor types including cytological or histologically diagnosed breast cancer and liver cancer
  • Patients with adequate bone marrow function, with absolute neutrophil count (ANC) >1,500/mm3, platelet count >100,000/mm3, and hemoglobin > 10 g/mm3
  • Patients with adequate kidney function, with serum creatinine ≤1.5 X upper limit of normal (ULN)
  • Patients with adequate liver function, with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN, total bilirubin ≤1.5x ULN ; For patients with liver metastasis, AST, ALT ≤5x ULN, Total bilirubin ≤1.5x ULN
  • Patients with adequate coagulation function, with activated partial thromboplastin time (aPTT) ≤1.5x ULN
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  • Female patients, if of childbearing potential, must have a negative serum pregnancy test within 72 hours prior to the date of the first dose of study medication.
  • Female patients of childbearing potential and male patients must agree to use adequate methods of contraception with their partner starting with the screening visit up to 4 weeks after the last dose of study therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Who cannot join

  • Known uncontrolled seizures, central nervous system disorders, or loss of cognitive ability due to mental illness
  • Pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
  • Patient is currently receiving or has received systemic corticosteroids within 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. The following use of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops or local injections (e.g., intra-articular).
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
  • Known serious, uncontrolled medical conditions that in the opinion of the investigator, will render it unsafe for the patient to receive the study therapy
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
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  • Patient has not recovered (i.e., to ≤ Grade 1 or to baseline) from radiation- and chemotherapy-induced adverse events (AEs) or administration of colony-stimulating factors (including granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF) or recombinant erythropoietin) within 3 weeks prior to the first dose of study drug.
  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational drug within 4 weeks prior to the first dose of study drug.
  • Received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days, or less than 5 times the half-life of the most recent therapy prior to study Day 1, whichever is shorter. Note: palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment will be allowed.
  • Patient has not recovered adequately (≤ Grade 1) from AEs and/or complications from any major surgery prior to starting therapy. Patient has received a vaccine within 7 days of planned start of study therapy.
  • Known hypersensitivity to YS-ON-001 components or excipients
  • Known unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction that occurred within a year, severe arrhythmia that required drug treatment, liver disease, kidney disease and metabolic diseases)
  • Known history of splenectomy
  • Known history of chronic alcohol or drug abuse within 6 months
  • PI assessment of subject's lack of willingness to participate and comply with all requirements of the protocol
  • Any other finding which, in the opinion of the PI would significantly increase the risk of having an adverse outcome from participating in this protocol.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National University Cancer Institute Singapore

    Singapore

Other trials in Singapore

About this study

Official title: Phase 1, Open Label, Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid Tumors

Phase 1 study evaluating the safety and tolerability of YS-ON-001 in patients with advanced solid tumors who have limited available treatment options, and exploratory evaluation of the pharmacological effect and efficacy of YS-ON-001. The study will be conducted in two parts: dose escalation and cohort expansion

Read the detailed description

This is an open-label, Phase 1 study of YS-ON-001 vaccine administered intramuscularly (IM) as a single agent to patients with advanced solid tumors. Patients are eligible if they are refractory, resistant or intolerant to prior therapies.The study will assess YS-ON-001 administered as a single agent, three times per week for 21-days with 1 week wash out period (28 days as 1 cycle) for 12 cycles in a continuous regimen. A dose escalation design will be applied in cohorts of 3-6 patients in Part I of the study.

The starting dose will be 2ml (3 times/ week). Once the recommended phase II dose (RP2D) is established, the cohort will be expanded with at least 10 additional patients to further characterize the safety and tolerability at RP2D with specific tumour types, Breast cancer and Liver Cancer

Treatment with YS-ON-001 may be continued for up to 12 cycles or until disease progression or if patient is withdrawn or unacceptable toxicity occurs. Patients who complete 12 cycles of treatment will be considered to have completed the trial. Patients who continue to benefit from treatment after 12 cycles may have the option to continue treatment upon agreement between the investigator and sponsor, and pending study drug availability.

Conditions
Cancer
Being tested
YS-0N-001
Medical subject headings
Neoplasms

What participants receive

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

  • YS-0N-001Biological

    Also called Polyinosinic-polycytidylic acid/inactivated rabies virus

    Cancer vaccine

Study groups in NCT03131765
Study groupRoleWhat they receive
YS-ON-001ExperimentalPhase 1- Dose escalation based on YS-ON-001 safety and tolerability obtained from three subjects enrolled in a cohort (first cycle of treatment), enrollment at the next dose level or additional subjects into the ongoing cohort will occur. Phase 1b- recommended dose determined in Phase 1. Enrollment of two expansion cohorts will be restricted to the tumour types, breast cancer and liver cancer
Receives: Biological: YS-0N-001

What is being measured

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

  1. Safety of YS-ON-001 by monitoring any adverse events (AE) and serious adverse events (SAE)

    To assess the safety of YS-ON-001 in patients with advanced (metastatic and/or unresectable) solid tumors based on the identification of any adverse events through study completion

    Measured: through study completion, an average of 1 year

  2. Tolerability of YS-ON-001 by recording AE /SAE, clinically significant changes in lab parameters and performance status (ECOG)

    To assess the tolerability of YS-ON-001 in patients with advanced (metastatic and/or unresectable) solid tumors for recommended phase II dose (RP2D)

    Measured: 6 months

  3. Dose-limiting toxicities (DLT)

    Number of Participants with a Dose Limiting Toxicity (DLT)

    Measured: For 4 weeks for DLTs

Secondary outcomes (2)

  1. Antitumor Activity of YS-ON-001 by imaging measurement and assessing using RECIST Version 1.1

    Assessment of antitumor activity of YS-ON-001 in advanced solid tumors based on the change of response rate on RECIST v1.1 at 2 months, 4 months., 6months, 9 months and 1 year

    Measured: At 2 months, 4 months., 6months, 9 months and 1 year

  2. Immunogenicity of YS-ON-001 evaluated by measuring serum titre level antibody against YS-ON-001

    To observe immune response in patients administered with YS-ON-001

    Measured: At 3 months, 6 months, 9 months and 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 posted27 Apr 2017
  2. Study start20 Apr 2017
  3. Primary completion15 Dec 2019
  4. Study completion16 Dec 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
Model description
YS-ON-001 is a single agent used for this study
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03131765
Sponsor's protocol ID
YS-RVON-001
Status last verified
Dec 2023
First submitted
7 Mar 2017
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YS-0N-001 in people with Cancer, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 1 site in Singapore.

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 9 inclusion and 16 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 5 Dec 2023. 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 Singapore. 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?

Safety of YS-ON-001 by monitoring any adverse events (AE) and serious adverse events (SAE) (time frame: through study completion, an average of 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 NCT03131765.

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 5 Dec 2023.

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