Advanced Solid TumorsPhase 1/2NCT04481009
A Study to Evaluate YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Subjects With Advanced Solid Tumors
A Phase 1/2 study testing YH003, Toripalimab and Nab-paclitaxel in people with Advanced Solid Tumors, run by Eucure (Beijing) Biopharma Co., Ltd at 1 site in Australia.
Trial summary
This is a phase I/II, multi-center, open-label study of YH003 in combination with Toripalimab (anti-PD-1 mAb). The study is comprised of a dose escalation part (Part I) exploring escalating doses of YH003 in combination with fixed dose toripalimab in subjects with advanced solid tumors (Part I), followed by an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- 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
- 26 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Aug 2020to 26 May 2022
- Phase
- Phase 1/2
- 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
- Subjects must have the ability to understand and willingness to sign a written informed consent document.
- Part I dose escalation:
- Have histologically advanced or cytologically confirmed solid tumor. Have progressed on after treatment with at least one standard therapy or intolerant of the standard therapy.
- Part II dose expansion:
- Cohort 2A: Histologically or cytologically confirmed unresectable or metastatic melanoma that had confirmed progressive disease during treatment with an anti-PD-1/PD-L1 therapy with or without additional CTLA-4 therapy. Subjects with BRAF activating mutation could have also received a BRAF inhibitor and/or MEK inhibitor regimen prior to anti-PD-1/PD-L1 therapy.
- Cohort 2B, 2C: Subject has histologically or cytologically documented diagnosis of pancreatic ductal adenocarcinoma with unresectable locally advanced/metastatic disease Cohort 2B: had confirmed progressive disease during treatment with first line standard of care of chemotherapy per local standard.
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- Cohort 2C: treatment-naïve for unresectable locally advanced/metastatic disease.
- Subject must have measurable disease by RECIST 1.1. At least 1 unidimensional measurable target lesion per RECIST v1.1 for study Part II expansion cohorts.
- Subjects must be age 18 years or older.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy ≥3 months.
- Subjects must have adequate organ function.
- Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test.
Who cannot join
- Part II Cohort 2A: History of life-threatening toxicity or treatment discontinuation due to related to prior anti-PD-1/PD-L1 and with or without CTLA-4 combination treatment for subjects with unresectable/metastatic melanoma.
- Subjects must not have another active invasive malignancy.
- Previous exposure to TNFR such as anti-CD137, OX40, CD27 and CD357 antibodies.
- 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.
- Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy.
- 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. Also history of severe hypersensitivity reaction to Nap-paclitaxel and/or gemcitabine.
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- Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
- History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease.
- Subjects must not have a known or suspected history of an autoimmune disorder, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
- Clinically uncontrolled intercurrent illness, including an ongoing or active infection, active coagulopathy, uncontrolled diabetes, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.
- 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.
- QTc > 450 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome.
- Subjects must not have active infection of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Subjects must not have a history of primary immunodeficiency.
- Subjects from endemic area will be specifically screened for tuberculosis. Subjects with active tuberculosis are excluded.
- Subjects must not receive concurrent or prior use of an immunosuppressive agent within 4 weeks of the first dose of YH003.
- Major surgery within 4 weeks prior to study entry and Minor surgery within 2 weeks prior to the first dose of YH003.
- Subjects must not have received a live attenuated vaccine within 28 days before the first dose of YH003, and subjects, if enrolled, should not receive live vaccines during the study or for 180 days after the last dose of YH003.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-Label, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Subjects With Advanced Solid Tumors
This is a phase I/II, multi-center, open-label study of YH003 in combination with Toripalimab (anti-PD-1 mAb). The study is comprised of a dose escalation part (Part I) exploring escalating doses of YH003 in combination with fixed dose toripalimab in subjects with advanced solid tumors (Part I), followed by an expansion part (Part II) with three expansion cohorts.
Read the detailed description
The study is comprised of a dose escalation part (Part I) exploring escalating doses of YH003 in combination with fixed dose toripalimab in subjects with advanced solid tumors (Part I), followed by an expansion part (Part II) with three expansion cohorts.
During Part I, dose escalation part of the study, a traditional 3+3 dose algorithm will be utilized to identify MTD(maximum tolerated dose) and/or RP2D (recommended phase 2 dose).
This dose escalation part will consist two phases, the run-in phase to explore safety and tolerability of YH003 as single agent and the combination phase to explore safety and tolerability of escalating doses of YH003 in combination with fixed dose Toripalimab.
The Phase II expansion part of this clinical trial will include three parallel cohorts(cohort 2A, 2B and 2C) of 20 subjects each treated with a dose around the RP2D of YH003 in combination with Toripalimab to assess the antitumor activity and safety/tolerability. One expansion cohort (2A) is YH003 and toripalimab in subjects with unresectable/metastatic melanoma, the other two expansion cohorts (2B and 2C) are YH003 and toripalimab with or without nab-paclitaxel + gemcitabine in unresectable/ metastatic pancreatic ductal adenocarcinoma.
Subjects will be monitored for safety, tolerability and efficacy throughout the study.
- Conditions
- Advanced Solid Tumors
- Being tested
- YH003, Toripalimab, Nab-paclitaxel, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH003Drug
YH003 will be administered intravenously over 60 minutes every 21-day cycle.
ToripalimabDrug
Toripalimab with fixed dose of 240 mg administered intravenously followed by YH003 administered intravenously every 21-day cycle.
Nab-paclitaxelDrug
Nab-paclitaxel will be administered each 21-day cycle.
GemcitabineDrug
Gemcitabine will be administrated each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| YH003 with Toripalimab after PD-1/L1 +/- CTLA-4 treatment | Experimental | YH003 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 PDAC | Experimental | YH003 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 chemotherapy | Experimental | YH003 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.
Overall safety and tolerability profile of YH003 in combination with Toripalimab.
The safety profile of YH003 in combination with Toripalimab will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
Measured: From screening up to 1 year
Maximum tolerated dose (MTD) and Recommended phase 2 dose (RP2D)
The MTD and RP2D will be determined based on the data of safety and tolerability
Measured: Cycle 1 of each cohort. Duration of one cycle is 3 weeks
Secondary outcomes (18)
Area under the serum concentration versus time curve (AUC)
To determine the PK profile of YH003 alone and in combination with Toripalimab
Measured: Up to 1 year
Maximum serum concentration (Cmax)
To determine the PK profile of YH003 alone and in combination with Toripalimab
Measured: Up to 1 year
Trough concentration before the next dose is administered (Ctrough)
To determine the PK profile of YH003 alone and in combination with Toripalimab
Measured: Up to 1 year
Time to reach maximum serum concentration (Tmax)
To determine the PK profile of YH003 alone and in combination with Toripalimab
Measured: Up to 1 year
Clearance (CL)
To determine the PK profile of YH003 alone and in combination with Toripalimab
Measured: Up to 1 year
Volume of distribution (Vd)
To determine the PK profile of YH003 alone and in combination with Toripalimab
Measured: Up to 1 year
Volume of distribution at steady state (Vss)
To determine the PK profile of YH003 alone and in combination with Toripalimab
Measured: Up to 1 year
Terminal half-life (T1/2)
To determine the PK profile of YH003 alone and in combination with Toripalimab
Measured: Up to 1 year
Dose proportionality
To determine the PK profile of YH003 alone and in combination with Toripalimab
Measured: Up to 1 year
Incidence of anti-drug antibodies (ADAs)
To assess the immunogenicity of YH003 in combination with Toripalimab
Measured: Up to 1 year
Incidence of neutralizing antibodies (NAbs)
To assess the immunogenicity of YH003 in combination with Toripalimab
Measured: Up to 1 year
Objective response rate (ORR)
To assess the preliminary antitumor activity of YH003 in combination with Toripalimab
Measured: Up to 1 year
Duration of response (DOR)
To assess the preliminary antitumor activity of YH003 in combination with Toripalimab
Measured: Up to 1 year
Time to response (TTR)
To assess the preliminary antitumor activity of YH003 in combination with Toripalimab
Measured: Up to 1 year
Progression free survival (PFS)
To assess the preliminary antitumor activity of YH003 in combination with Toripalimab
Measured: Up to 1 year
Overall survival (OS)
To assess the preliminary antitumor activity of YH003 in combination with Toripalimab
Measured: Up to 1 year
Disease control rate (DCR)
To assess the preliminary antitumor activity of YH003 in combination with Toripalimab
Measured: Up to 1 year
Duration of disease control (DDC)
To assess the preliminary antitumor activity of YH003 in combination with Toripalimab
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start4 Aug 2020
- Primary completion16 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eucure (Beijing) Biopharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481009
- Sponsor's protocol ID
- YH003002
- Status last verified
- Oct 2022
- First submitted
- 17 Jul 2020
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04481009
- Acronym / sponsor ID
- YH003002
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Eucure (Beijing) Biopharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I/II, multi-center, open-label study of YH003 in combination with Toripalimab (anti-PD-1 mAb). The study is comprised of a dose escalation part (Part I) exploring escalating doses of YH003 in combination with fixed dose toripalimab in subjects with advanced solid tumors (Part I), followed by an expansion part (Part II) with three expansion cohorts.
Detailed description
The study is comprised of a dose escalation part (Part I) exploring escalating doses of YH003 in combination with fixed dose toripalimab in subjects with advanced solid tumors (Part I), followed by an expansion part (Part II) with three expansion cohorts.
During Part I, dose escalation part of the study, a traditional 3+3 dose algorithm will be utilized to identify MTD(maximum tolerated dose) and/or RP2D (recommended phase 2 dose).
This dose escalation part will consist two phases, the run-in phase to explore safety and tolerability of YH003 as single agent and the combination phase to explore safety and tolerability of escalating doses of YH003 in combination with fixed dose Toripalimab.
The Phase II expansion part of this clinical trial will include three parallel cohorts(cohort 2A, 2B and 2C) of 20 subjects each treated with a dose around the RP2D of YH003 in combination with Toripalimab to assess the antitumor activity and safety/tolerability. One expansion cohort (2A) is YH003 and toripalimab in subjects with unresectable/metastatic melanoma, the other two expansion cohorts (2B and 2C) are YH003 and toripalimab with or without nab-paclitaxel + gemcitabine in unresectable/ metastatic pancreatic ductal adenocarcinoma.
Subjects will be monitored for safety, tolerability and efficacy throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YH003 with Toripalimab after PD-1/L1 +/- CTLA-4 treatment | Experimental | Drug: YH003, Drug: ToripalimabYH003 in combination with Toripalimab in subjects with unresectable /metastatic melanoma after having failed PD-1/L1 +/- CTLA-4 treatment. |
| YH003 with Toripalimab in subjects with PDAC | Experimental | Drug: YH003, Drug: ToripalimabYH003 in combination with Toripalimab in subjects with unresectable/ metastatic pancreatic ductal adenocarcinoma (PDAC) as 2nd line treatment. |
| YH003 with Toripalimab plus standard chemotherapy | Experimental | Drug: YH003, Drug: Toripalimab, Drug: Nab-paclitaxel, Drug: GemcitabineYH003 in combination with Toripalimab plus standard chemotherapy (Nab-paclitaxel + Gemcitabine) in subjects with unresectable/metastatic PDAC as 1st line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must have the ability to understand and willingness to sign a written informed consent document.
- Part I dose escalation:
- Have histologically advanced or cytologically confirmed solid tumor. Have progressed on after treatment with at least one standard therapy or intolerant of the standard therapy.
- Cohort 2A: Histologically or cytologically confirmed unresectable or metastatic melanoma that had confirmed progressive disease during treatment with an anti-PD-1/PD-L1 therapy with or without additional CTLA-4 therapy. Subjects with BRAF activating mutation could have also received a BRAF inhibitor and/or MEK inhibitor regimen prior to anti-PD-1/PD-L1 therapy.
- Cohort 2B, 2C: Subject has histologically or cytologically documented diagnosis of pancreatic ductal adenocarcinoma with unresectable locally advanced/metastatic disease Cohort 2B: had confirmed progressive disease during treatment with first line standard of care of chemotherapy per local standard.
Key exclusion criteria (18 listed)
- Part II Cohort 2A: History of life-threatening toxicity or treatment discontinuation due to related to prior anti-PD-1/PD-L1 and with or without CTLA-4 combination treatment for subjects with unresectable/metastatic melanoma.
- Subjects must not have another active invasive malignancy.
- Previous exposure to TNFR such as anti-CD137, OX40, CD27 and CD357 antibodies.
- 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.
- Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YH003YH003 will be administered intravenously over 60 minutes every 21-day cycle. | Drug | YH003 with Toripalimab after PD-1/L1 +/- CTLA-4 treatment, YH003 with Toripalimab in subjects with PDAC, YH003 with Toripalimab plus standard chemotherapy |
| ToripalimabToripalimab with fixed dose of 240 mg administered intravenously followed by YH003 administered intravenously every 21-day cycle. | Drug | YH003 with Toripalimab after PD-1/L1 +/- CTLA-4 treatment, YH003 with Toripalimab in subjects with PDAC, YH003 with Toripalimab plus standard chemotherapy |
| Nab-paclitaxelNab-paclitaxel will be administered each 21-day cycle. | Drug | YH003 with Toripalimab plus standard chemotherapy |
| GemcitabineGemcitabine will be administrated each 21-day cycle. | Drug | YH003 with Toripalimab plus standard chemotherapy |
Primary outcome
Overall safety and tolerability profile of YH003 in combination with Toripalimab.
Time frame: From screening up to 1 year
The safety profile of YH003 in combination with Toripalimab will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
Maximum tolerated dose (MTD) and Recommended phase 2 dose (RP2D)
Time frame: Cycle 1 of each cohort. Duration of one cycle is 3 weeks
The MTD and RP2D will be determined based on the data of safety and tolerability
18 secondary outcomes
Area under the serum concentration versus time curve (AUC)
Time frame: Up to 1 year
Maximum serum concentration (Cmax)
Time frame: Up to 1 year
Trough concentration before the next dose is administered (Ctrough)
Time frame: Up to 1 year
Time to reach maximum serum concentration (Tmax)
Time frame: Up to 1 year
Clearance (CL)
Time frame: Up to 1 year
Volume of distribution (Vd)
Time frame: Up to 1 year
Volume of distribution at steady state (Vss)
Time frame: Up to 1 year
Terminal half-life (T1/2)
Time frame: Up to 1 year
Dose proportionality
Time frame: Up to 1 year
Incidence of anti-drug antibodies (ADAs)
Time frame: Up to 1 year
Incidence of neutralizing antibodies (NAbs)
Time frame: Up to 1 year
Objective response rate (ORR)
Time frame: Up to 1 year
Duration of response (DOR)
Time frame: Up to 1 year
Time to response (TTR)
Time frame: Up to 1 year
Progression free survival (PFS)
Time frame: Up to 1 year
Overall survival (OS)
Time frame: Up to 1 year
Disease control rate (DCR)
Time frame: Up to 1 year
Duration of disease control (DDC)
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YH003, Toripalimab and Nab-paclitaxel in people with Advanced Solid Tumors, run by Eucure (Beijing) Biopharma Co., Ltd at 1 site in Australia.
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 12 inclusion and 18 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Overall safety and tolerability profile of YH003 in combination with Toripalimab. (time frame: From screening up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2022.