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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05031494
Registration number
NCT05031494
Ethics application status
Date submitted
26/08/2021
Date registered
2/09/2021
Date last updated
13/09/2023
Titles & IDs
Public title
A Study to Assess YH003 in Combination With Toripalimab(Anti-PD-1 mAb) Injection in Patients With Cancers
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Scientific title
A Multi-center, Open-label Phase II Study to Evaluate the Safety and Efficacy of YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Patients With Unresectable/Metastatic Melanoma and Pancreatic Ductal Adenocarcinoma (PDAC)
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Secondary ID [1]
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YH003004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Pancreatic Ductal Adenocarcinoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - YH003
Treatment: Drugs - Toripalimab
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine
Experimental: YH003 with Toripalimab in subjects with unresectable /metastatic melanoma - YH003 in combination with Toripalimab in subjects with unresectable /metastatic melanoma after having failed PD-1/L1 +/- CTLA-4 treatment;
Experimental: YH003 with Toripalimab in subjects with PDAC - YH003 in combination with Toripalimab in subjects with unresectable/ metastatic pancreatic ductal adenocarcinoma (PDAC) as 2nd line treatment;
Experimental: YH003 with Toripalimab plus standard chemotherapy - YH003 in combination with Toripalimab plus standard chemotherapy (Nab-paclitaxel + Gemcitabine) in subjects with unresectable/metastatic PDAC as 1st line treatment;
Treatment: Drugs: YH003
YH003 will be dosed at RP2D every 3 weeks. The first infusion of YH003 should be administered over 60 minutes.
Treatment: Drugs: Toripalimab
Toripalimab will be administered at a dose of 240 mg every 3 weeks.
Treatment: Drugs: Nab-paclitaxel
Nab-paclitaxel will be administered each 21-day cycle.
Treatment: Drugs: Gemcitabine
Gemcitabine will be administrated each 21-day cycle.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Confirmed Objective Response Rate (ORR)
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Assessment method [1]
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Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Timepoint [1]
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up to 1 year after the last dosing
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Secondary outcome [1]
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Adverse events (AE)
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Assessment method [1]
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The safety profile of YH003 in combination with Toripalimab will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
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Timepoint [1]
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up to 1 year after the last dosing
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Secondary outcome [2]
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Duration of response (DOR)
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Assessment method [2]
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To assess the antitumor activity of YH003 in combination with Toripalimab
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Timepoint [2]
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up to 1 year after the last dosing
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Secondary outcome [3]
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Time to response (TTR)
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Assessment method [3]
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To assess the antitumor activity of YH003 in combination with Toripalimab
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Timepoint [3]
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up to 1 year after the last dosing
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Secondary outcome [4]
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Progression free survival (PFS)
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Assessment method [4]
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To assess the antitumor activity of YH003 in combination with Toripalimab
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Timepoint [4]
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up to 1 year after the last dosing
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Secondary outcome [5]
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Disease control rate (DCR)
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Assessment method [5]
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To assess the antitumor activity of YH003 in combination with Toripalimab
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Timepoint [5]
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up to 1 year after the last dosing
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Secondary outcome [6]
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Duration of disease control (DDC)
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Assessment method [6]
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To assess the antitumor activity of YH003 in combination with Toripalimab
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Timepoint [6]
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up to 1 year after the last dosing
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Secondary outcome [7]
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Overall survival (OS)
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Assessment method [7]
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To assess the antitumor activity of YH003 in combination with Toripalimab
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Timepoint [7]
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up to 1 year after the last dosing
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Secondary outcome [8]
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Incidence of neutralizing antibodies (NAbs)
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Assessment method [8]
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To assess the immunogenicity of YH003 in combination with Toripalimab
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Timepoint [8]
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up to 1 year after the last dosing
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Eligibility
Key inclusion criteria
- To be eligible for study entry patients must satisfy all of the following criteria:
- 1. Subjects must have the ability to understand and willingness to sign a written
informed consent document.
- 2. Histologically or cytologically confirmed unresectable or metastatic melanoma and
pancreatic ductal adenocarcinoma
- Cohort 2A: had confirmed progressive disease during treatment with an anti-PD-1/PD-L1
with or without CTLA-4 therapy.
- Cohort 2B: had confirmed progressive disease during treatment with first line standard
of care chemotherapy per local guideline.
- Cohort 2C: must not have received any prior systematic treatment, including
chemotherapy, biological therapy, or targeted therapy for unresectable locally
advanced/ metastatic pancreatic duct adenocarcinoma.
- 3. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1.
- 4. Subjects must be age between 18 years.
- 5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 or 1.
- 6. Life expectancy =3 months.
- 7. Subjects must have adequate organ function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects who meet any of the following criteria cannot be enrolled:
- 1. Cohort 2A: History of life-threatening toxicity or treatment discontinuation due to
related to prior anti-PD-1/PD-L1 with or without CTLA-4 treatment for subjects with
unresectable/ metastatic melanoma
- 2.Subjects have another active invasive malignancy within 5 years, with the following
exceptions and notes:
- 3. Previous exposure to TNFR such as anti-CD137, OX40, CD27 and CD357 antibodies.
- 4. Subjects must not have received any anticancer therapy or another investigational
agent within the shorter of 4 weeks or 5 half-lives before the first dose of the study
treatment.
- 5. Subjects with a history of = Grade 3 immune-related adverse events resulted from
previous immunotherapy or treatment discontinuation due to previous immunotherapy. .
- 6. History of clinically significant sensitivity or allergy to monoclonal antibodies
and their excipients or known allergies to antibodies produced from Chinese hamster
ovary cells, which in the opinion of the Investigator suggests an increased potential
for an adverse hypersensitivity to YH003 or Toripalimab. (For cohort 2C: history of
severe hypersensitivity reaction to Nap-paclitaxel and/or gemcitabine).
- 7. Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
- 8. History of (non-infectious) pneumonitis that required corticosteroids or current
pneumonitis, or history of interstitial lung disease.
- 9. Active, hemodynamically significant pulmonary embolism within 12 weeks prior to the
first dose of study drug.
- 10. Subjects must not have a known or suspected history of an autoimmune disorder
- 11. Clinically uncontrolled intercurrent illness,
- 12. Severe cardiovascular disease including symptomatic congestive heart failure (New
York Heart Association class III or IV), unstable angina, uncontrolled hypertension,
cardiac arrhythmia, a history of myocardial infarction within 6 months or a history of
arterial thromboembolic event and pulmonary embolism within 3 months of the first dose
of investigational agent.
- 13. QTc > 480 ms (Fridericia equation) at baseline; no concomitant medications that
would prolong the QT interval; no family history of long QT syndrome.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2024
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Actual
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Sample size
Target
129
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Epworth Medical Centre - Richmond
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Recruitment postcode(s) [1]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eucure (Beijing) Biopharma Co., Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A phase II, multi-center, open-label study to evaluate the safety and efficacy of YH003 in
combination with Toripalimab (anti-PD-1 mAb) in patients with unresectable/metastatic
melanoma and pancreatic ductal adenocarcinoma (PDAC)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05031494
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05031494
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