We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    YH003004
Previous Study | Return to List | Next Study

A Study to Assess YH003 in Combination With Toripalimab(Anti-PD-1 mAb) Injection in Patients With Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05031494
Recruitment Status : Active, not recruiting
First Posted : September 2, 2021
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Eucure (Beijing) Biopharma Co., Ltd

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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)

Condition or disease Intervention/treatment Phase
Melanoma Pancreatic Ductal Adenocarcinoma Drug: YH003 Drug: Toripalimab Drug: Nab-paclitaxel Drug: Gemcitabine Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : December 8, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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;
 Drug: YH003
YH003 will be dosed at RP2D every 3 weeks. The first infusion of YH003 should be administered over 60 minutes.

Drug: Toripalimab
Toripalimab will be administered at a dose of 240 mg every 3 weeks.
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;
 Drug: YH003
YH003 will be dosed at RP2D every 3 weeks. The first infusion of YH003 should be administered over 60 minutes.

Drug: Toripalimab
Toripalimab will be administered at a dose of 240 mg every 3 weeks.
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;
 Drug: YH003
YH003 will be dosed at RP2D every 3 weeks. The first infusion of YH003 should be administered over 60 minutes.

Drug: Toripalimab
Toripalimab will be administered at a dose of 240 mg every 3 weeks.

Drug: Nab-paclitaxel
Nab-paclitaxel will be administered each 21-day cycle.

Drug: Gemcitabine
Gemcitabine will be administrated each 21-day cycle.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Confirmed Objective Response Rate (ORR) [ Time Frame: up to 1 year after the last dosing ]
    Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1


Secondary Outcome Measures :
  1. Adverse events (AE) [ Time Frame: up to 1 year after the last dosing ]
    The safety profile of YH003 in combination with Toripalimab will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

  2. Duration of response (DOR) [ Time Frame: up to 1 year after the last dosing ]
    To assess the antitumor activity of YH003 in combination with Toripalimab

  3. Time to response (TTR) [ Time Frame: up to 1 year after the last dosing ]
    To assess the antitumor activity of YH003 in combination with Toripalimab

  4. Progression free survival (PFS) [ Time Frame: up to 1 year after the last dosing ]
    To assess the antitumor activity of YH003 in combination with Toripalimab

  5. Disease control rate (DCR) [ Time Frame: up to 1 year after the last dosing ]
    To assess the antitumor activity of YH003 in combination with Toripalimab

  6. Duration of disease control (DDC) [ Time Frame: up to 1 year after the last dosing ]
    To assess the antitumor activity of YH003 in combination with Toripalimab

  7. Overall survival (OS) [ Time Frame: up to 1 year after the last dosing ]
    To assess the antitumor activity of YH003 in combination with Toripalimab

  8. Incidence of neutralizing antibodies (NAbs) [ Time Frame: up to 1 year after the last dosing ]
    To assess the immunogenicity of YH003 in combination with Toripalimab


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05031494


Locations
Layout table for location information
United States, New York
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Australia, Victoria
Epworth Medical Centre
Richmond, Victoria, Australia, 3121
Sponsors and Collaborators
Eucure (Beijing) Biopharma Co., Ltd
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Eucure (Beijing) Biopharma Co., Ltd
ClinicalTrials.gov Identifier: NCT05031494    
Other Study ID Numbers: YH003004
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Adenocarcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Carcinoma
Neoplasms, Glandular and Epithelial
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs