AzTrials
AzTrials

MelanomaPhase 2NCT05031494

A Study to Assess YH003 in Combination with Toripalimab(anti-PD-1 MAb) Injection in Patients with Cancers

A Phase 2 study testing YH003, Toripalimab and Nab-paclitaxel in people with Melanoma and Pancreatic Ductal Adenocarcinoma, run by Eucure (Beijing) Biopharma Co., Ltd at 2 sites in 2 countries.

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

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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Pancreatic Ductal Adenocarcinoma
What is being tested?
YH003, Toripalimab and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesin 2 countries
Study dates
8 Dec 2021to 16 Aug 2023
Phase
Phase 2
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

  • 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.
Show all 11Show fewer
  • 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

Who cannot join

  • 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. .
Show all 14Show fewer
  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Ichan School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

Australia1 site

  • Epworth Medical Centre

    Richmond, Victoria, 3121

Other trials in Australia

About this study

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)

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)

Medical subject headings
Melanoma

What participants receive

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

  • YH003Drug

    YH003 will be dosed at RP2D every 3 weeks. The first infusion of YH003 should be administered over 60 minutes.

  • ToripalimabDrug

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

  • Nab-paclitaxelDrug

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

  • GemcitabineDrug

    Gemcitabine will be administrated each 21-day cycle.

Study groups in NCT05031494
Study groupRoleWhat they receive
YH003 with Toripalimab in subjects with unresectable /metastatic melanomaExperimentalYH003 in combination with Toripalimab in subjects with unresectable /metastatic melanoma after having failed PD-1/L1 +/- CTLA-4 treatment;
Receives: Drug: YH003; Drug: Toripalimab
YH003 with Toripalimab in subjects with PDACExperimentalYH003 in combination with Toripalimab in subjects with unresectable/ metastatic pancreatic ductal adenocarcinoma (PDAC) as 2nd line treatment;
Receives: Drug: YH003; Drug: Toripalimab
YH003 with Toripalimab plus standard chemotherapyExperimentalYH003 in combination with Toripalimab plus standard chemotherapy (Nab-paclitaxel + Gemcitabine) in subjects with unresectable/metastatic PDAC as 1st line treatment;
Receives: Drug: YH003; Drug: Toripalimab; Drug: Nab-paclitaxel; Drug: Gemcitabine

What is being measured

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

  1. Confirmed Objective Response Rate (ORR)

    Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: up to 1 year after the last dosing

Secondary outcomes (8)

  1. Adverse events (AE)

    The safety profile of YH003 in combination with Toripalimab will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

    Measured: up to 1 year after the last dosing

  2. Duration of response (DOR)

    To assess the antitumor activity of YH003 in combination with Toripalimab

    Measured: up to 1 year after the last dosing

  3. Time to response (TTR)

    To assess the antitumor activity of YH003 in combination with Toripalimab

    Measured: up to 1 year after the last dosing

  4. Progression free survival (PFS)

    To assess the antitumor activity of YH003 in combination with Toripalimab

    Measured: up to 1 year after the last dosing

  5. Disease control rate (DCR)

    To assess the antitumor activity of YH003 in combination with Toripalimab

    Measured: up to 1 year after the last dosing

  6. Duration of disease control (DDC)

    To assess the antitumor activity of YH003 in combination with Toripalimab

    Measured: up to 1 year after the last dosing

  7. Overall survival (OS)

    To assess the antitumor activity of YH003 in combination with Toripalimab

    Measured: up to 1 year after the last dosing

  8. Incidence of neutralizing antibodies (NAbs)

    To assess the immunogenicity of YH003 in combination with Toripalimab

    Measured: up to 1 year after the last dosing

Timeline

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

  1. First posted2 Sep 2021
  2. Study start8 Dec 2021
  3. Primary completion16 Aug 2023
  4. Study completion16 Aug 2023

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05031494
Sponsor's protocol ID
YH003004
Status last verified
Jan 2025
First submitted
26 Aug 2021
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YH003, Toripalimab and Nab-paclitaxel in people with Melanoma and Pancreatic Ductal Adenocarcinoma, run by Eucure (Beijing) Biopharma Co., Ltd at 2 sites in 2 countries.

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 11 inclusion and 14 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 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Confirmed Objective Response Rate (ORR) (time frame: up to 1 year after the last dosing). 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 NCT05031494.

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 6 Jan 2025.

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