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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
Secondary ID [1] 0 0
YH003004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Pancreatic Ductal Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Objective Response Rate (ORR)
Timepoint [1] 0 0
up to 1 year after the last dosing
Secondary outcome [1] 0 0
Adverse events (AE)
Timepoint [1] 0 0
up to 1 year after the last dosing
Secondary outcome [2] 0 0
Duration of response (DOR)
Timepoint [2] 0 0
up to 1 year after the last dosing
Secondary outcome [3] 0 0
Time to response (TTR)
Timepoint [3] 0 0
up to 1 year after the last dosing
Secondary outcome [4] 0 0
Progression free survival (PFS)
Timepoint [4] 0 0
up to 1 year after the last dosing
Secondary outcome [5] 0 0
Disease control rate (DCR)
Timepoint [5] 0 0
up to 1 year after the last dosing
Secondary outcome [6] 0 0
Duration of disease control (DDC)
Timepoint [6] 0 0
up to 1 year after the last dosing
Secondary outcome [7] 0 0
Overall survival (OS)
Timepoint [7] 0 0
up to 1 year after the last dosing
Secondary outcome [8] 0 0
Incidence of neutralizing antibodies (NAbs)
Timepoint [8] 0 0
up to 1 year after the last dosing

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2024
Actual
Sample size
Target
129
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth Medical Centre - Richmond
Recruitment postcode(s) [1] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eucure (Beijing) Biopharma Co., Ltd
Address
Country

Ethics approval
Ethics application status

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)
Trial website
https://clinicaltrials.gov/study/NCT05031494
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05031494