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YH003 + Toripalimab for Melanoma

Phase 2

Waitlist Available

Research Sponsored by Eucure (Beijing) Biopharma Co., Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year after the last dosing

Awards & highlights

Study Summary

This trialstudies a drug combo to help treat melanoma & pancreatic cancer that cannot be surgically removed.

Who is the study for?

This trial is for adults with unresectable or metastatic melanoma and pancreatic cancer who understand the study and consent to participate. They must have measurable disease, be aged 18+, have a good performance status (ECOG 0-1), a life expectancy of at least 3 months, and proper organ function.Check my eligibility

What is being tested?

The study tests YH003 in combination with Toripalimab against cancers like melanoma and pancreatic cancer. It's an open-label phase II trial, meaning both researchers and participants know what treatment is being given.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions due to anti-PD-1 therapy, infusion-related responses, allergic reactions to monoclonal antibodies or their components, as well as typical chemotherapy-associated risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after the last dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year after the last dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after the last dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Confirmed Objective Response Rate (ORR)

Secondary outcome measures

Adverse events (AE)

Disease control rate (DCR)

Duration of disease control (DDC)

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: YH003 with Toripalimab plus standard chemotherapyExperimental Treatment4 Interventions

YH003 in combination with Toripalimab plus standard chemotherapy (Nab-paclitaxel + Gemcitabine) in subjects with unresectable/metastatic PDAC as 1st line treatment;

Group II: YH003 with Toripalimab in subjects with unresectable /metastatic melanomaExperimental Treatment2 Interventions

YH003 in combination with Toripalimab in subjects with unresectable /metastatic melanoma after having failed PD-1/L1 +/- CTLA-4 treatment;

Group III: YH003 with Toripalimab in subjects with PDACExperimental Treatment2 Interventions

YH003 in combination with Toripalimab in subjects with unresectable/ metastatic pancreatic ductal adenocarcinoma (PDAC) as 2nd line treatment;

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

YH003

2021

Completed Phase 2

~40

Toripalimab

2017

Completed Phase 2

~680

Nab-paclitaxel

2014

Completed Phase 3

~2030

Gemcitabine

2017

Completed Phase 3

~2070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eucure (Beijing) Biopharma Co., LtdLead Sponsor

11 Previous Clinical Trials

274 Total Patients Enrolled

1 Trials studying Melanoma

43 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of YH003 and Toripalimab in conjunction with traditional chemotherapy been accepted by the FDA?

"The safety of YH003 in combination with Toripalimab and standard chemotherapy has been judged to be a 2 on the Power team's scale, as it is currently undergoing Phase 2 trials which have established some efficacy but no guarantees."

Answered by AI

What therapeutic purpose does the combination of YH003 and Toripalimab alongside traditional chemotherapy usually serve?

"YH003 combined with Toripalimab and standard chemotherapy is commonly used to treat cancer metastasis. It has also been employed in certain cases of advanced non-small cell lung cancer, bladder cancer, and urinary tract infections."

Answered by AI

Has the combination of YH003 and Toripalimab with standard chemotherapy been tested in other research studies?

"Currently, 1225 studies are in progress that investigate the efficacy of YH003 with Toripalimab plus standard chemotherapy. Of these trials, 333 have progressed to Phase 3. While most locations conducting research on this treatment reside in Shanghai, there are over 60000 sites worldwide where experimentation is underway."

Answered by AI

What is the present sample size for this clinical research?

"No longer recruiting, this experiment began on December 8th 2021 and was last modified a year later. For those in search of other trials, there are currently 1550 melanoma studies with open recruitment periods and 1225 for YH003with Toripalimab plus standard chemotherapy still looking for participants."

Answered by AI

Is this investigation currently enrolling participants?

"This study is currently not recruiting, as the trial was first posted on December 8th 2021 and last updated on December 9th 2022. However, for individuals looking to participate in medical trials related to melanoma, there are 1,550 active studies available; likewise 1225 clinical tests involving Toripalimab plus standard chemotherapy can be found actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study to Assess YH003 in Combination With Toripalimab(Anti-PD-1 mAb) Injection in Patients With Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05031494.