Advanced Solid TumorsPhase 1/2NCT06026501
A Phase Ib/II Clinical Trial of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor
A Phase 1/2 study testing PE0116,PE0105 in people with Advanced Solid Tumors, run by Shanghai YingLi Pharmaceutical Co. Ltd..
Trial summary
This study is a one-arm, open, multicenter phase 1b/2 clinical trial of PE0116combined with PE0105 in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.PE0105 is administered… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- PE0116,PE0105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2023to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who voluntarily sign the informed consent form, understand the study and are willing to follow and able to complete all study procedures,
- Male or female, 75 ≥ age ≥ 18 years,
- Patients enrolled in Phase Ib are those with histopathologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent solid tumors (ovarian cancer, cervical cancer, renal cancer, head and neck cancer, etc.) who have failed to respond to or are intolerant to standard treatment regimens or have no standard effective treatment regimen, and at least one evaluable lesion meeting the definition of RECISTv1.1,
- Patients enrolled in Phase II must have at least 1 measurable lesion consistent with the definition of RECISTv1.1 and need to meet one of the following tumor types: a).histologically and/or cytologically confirmed diagnosis of advanced renal cancer, head and neck cancer, or cervical cancer who have failed at least 1 line of prior therapy with PD-1 and anti-PD-1/PD-L1 antibodies alone or in combination with chemotherapy; failure of anti-PD-1/PD-L1 antibodies is defined as disease progression after achieving complete response (CR) or partial response (PR) with anti-PD-1/PD-L1 antibodies alone or in combination with chemotherapy, or disease progression after ≥ 6 months of stable disease (SD); b). histologically and/or cytologically confirmed diagnosis of ovarian cancer who have received 1 line of prior therapy consisting of at least 1 platinum agent and imaging evidence of disease progression within 6 months of the last dose of platinum-based chemotherapy,
- Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
- Patients who have a life expectancy of at least 3 months,
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- Patients who are ≥ 4 weeks after receiving anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, endocrine therapy and immunotherapy before the first dose of study drug,
- Patients need to have appropriate organ and hematopoietic function, laboratory tests，
- Male and female patients of childbearing potential should agree to use effective contraception from the signing of the informed consent form until 3 months after the last dose.
Who cannot join
- Patients with clinically symptomatic central nervous system metastases and/or carcinomatous meningitis,
- Patients who have previously failed to recover from adverse reactions to CTCAE V5.0 grade ≤ 1,
- Uncontrolled stable systemic disease with treatment，
- Any active autoimmune disease or documented autoimmune disease, or systemic syndrome previously requiring systemic steroids or immunosuppressive drugs，
- Patients who require systemic corticosteroids (at doses equivalent to > 10 mg prednisone/day) or other immunosuppressive drugs within 14 days before enrollment or during the study，
- History of infection with human immunodeficiency virus, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation, or stem cell transplantation，
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- Patients who have pulmonary tuberculosis and are in active phase at screening，
- Patients with active chronic hepatitis B or active hepatitis C，
- Patients who have received anti-4-1BB target drugs，
- Known subjects who have previously treated with macromolecular protein agents/monoclonal antibodies, or known to have a serious allergic reaction to any component of the test drug (CTCAE V5.0 grade greater than 3)，
- Patient plan to have major surgery during this study including a 28-day screening period，
- Severe infection within 4 weeks before the first dose,Or patients with active infection requiring intravenous antibiotics within the first 2 weeks,
- Patient participated in other clinical trials of drugs within 4 weeks before enrollment and have been enrolled in drug therapy, or did not reach 4 weeks after the end of treatment (EOT),
- Patient had a history of alcoholism, drug abuse or drug abuse within the past 1 year,
- Patien had ≥ grade 3 irAEs or ≥ grade 2 immune-related myocarditis in previous immunotherapy,
- Patient had a history of other primary malignancies ,
- Patient had a history of moderate or severe dyspnea at rest due to advanced malignancies or their complications or severe primary lung disease, or currently required continuous oxygen therapy, or currently had interstitial lung disease (ILD) or pneumonia,
- Patient received live attenuated vaccines within 4 weeks before the first dose or planned to receive during the study,
- Patient had a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, and poor compliance,
- Patient was pregnant or lactating women; Eligible patients of childbearing potential (men and women) did not agree to use a reliable method of contraception during the trial and for at least 3 months after the last dose, and female patients of childbearing age had a positive blood or urine pregnancy test within 7 days before enrollment,
- Patients who were considered by the investigator to be unsuitable for participation in the trial for other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib/II Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor
This study is a one-arm, open, multicenter phase 1b/2 clinical trial of PE0116combined with PE0105 in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.PE0105 is administered as a fixed-dose intravenous injection(3mg/kg Q3w）.
Read the detailed description
Phase Ib
This is a dose escalation,3+3 design study, to evaluate the safety and tolerability, and to determine the RP2D of PE0116 injection in patients with advanced solid tumors. One cycle is 21 days.
Phase II
This is an expansion phase in patients with advanced solid tumors such as ovarian cancer, cervical cancer, renal cancer, head and neck cancer to further evaluate the safety, tolerability and preliminary anti-tumor activity of PE0116 injection at the RP2D combined with PE0105 injection every three weeks.
- Conditions
- Advanced Solid Tumors
- Being tested
- PE0116,PE0105
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PE0116,PE0105Drug
Also called PE0116 injection，PE0105 injection
- PE0116: 4-1BB Agonist Antibody Drug
- PE0105: PD-1 Monoclonal Antibody Drug
| Study group | Role | What they receive |
|---|---|---|
| PE0116+PE0105 | Experimental | PE0116 injection will be given 1mg/kg or 2mg/kg every three weeks and PE0105 injection will be given 3mg/kg every threee weeks until there appears evidence of progressive disease, intolerable toxicity, or the patient discontinues from the study treatment for other reasons. Receives: Drug: PE0116,PE0105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicities evaluated by NCI-CTCAE v5.0
Incidence of dose limited toxicities and associated dose of PE0105 and PE0116
Measured: From time of first dose to 21 days after the first dose.
Adverse events evaluated by NCI CTCAE v5.0
Incidence of adverse events and associated dose of PE0105 and PE0116
Measured: From time of first dose to 90 days after the last dose.
Recommended Phase 2 Dose
Recommended dose for phase II clinical trial is explored through dose escalation in phase Ib clinical trial.
Measured: From time of first dose of the first patient to the last dose of the last patient in phase 1b..
Objective response rate
The proportion of subjects who have a Complete Response or Partial Response
Measured: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Secondary outcomes (2)
Disease control rate
The proportion of subjects who have a Complete Response or Partial Response
Measured: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Plasma concentration of PE0116 and PE0105
This composite endpoint will measure the plasma concentration of PE0116 and PE0105.
Measured: From one hour before the first dose to 90 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start31 Aug 2023 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai HyaMab Biotech Co.,Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026501
- Sponsor's protocol ID
- YL-0116-002
- Status last verified
- Sep 2023
- First submitted
- 15 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT06026501
- Acronym / sponsor ID
- YL-0116-002
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai HyaMab Biotech Co.,Ltd.
- Study start
- 31 Aug 2023 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Sep 2023 (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 study is a one-arm, open, multicenter phase 1b/2 clinical trial of PE0116combined with PE0105 in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.PE0105 is administered as a fixed-dose intravenous injection(3mg/kg Q3w）.
Detailed description
Phase Ib
This is a dose escalation,3+3 design study, to evaluate the safety and tolerability, and to determine the RP2D of PE0116 injection in patients with advanced solid tumors. One cycle is 21 days.
Phase II
This is an expansion phase in patients with advanced solid tumors such as ovarian cancer, cervical cancer, renal cancer, head and neck cancer to further evaluate the safety, tolerability and preliminary anti-tumor activity of PE0116 injection at the RP2D combined with PE0105 injection every three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PE0116+PE0105 | Experimental | Drug: PE0116,PE0105PE0116 injection will be given 1mg/kg or 2mg/kg every three weeks and PE0105 injection will be given 3mg/kg every threee weeks until there appears evidence of progressive disease, intolerable toxicity, or the patient discontinues from the study treatment for other reasons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who voluntarily sign the informed consent form, understand the study and are willing to follow and able to complete all study procedures,
- Male or female, 75 ≥ age ≥ 18 years,
- Patients enrolled in Phase Ib are those with histopathologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent solid tumors (ovarian cancer, cervical cancer, renal cancer, head and neck cancer, etc.) who have failed to respond to or are intolerant to standard treatment regimens or have no standard effective treatment regimen, and at least one evaluable lesion meeting the definition of RECISTv1.1,
- Patients enrolled in Phase II must have at least 1 measurable lesion consistent with the definition of RECISTv1.1 and need to meet one of the following tumor types: a).histologically and/or cytologically confirmed diagnosis of advanced renal cancer, head and neck cancer, or cervical cancer who have failed at least 1 line of prior therapy with PD-1 and anti-PD-1/PD-L1 antibodies alone or in combination with chemotherapy; failure of anti-PD-1/PD-L1 antibodies is defined as disease progression after achieving complete response (CR) or partial response (PR) with anti-PD-1/PD-L1 antibodies alone or in combination with chemotherapy, or disease progression after ≥ 6 months of stable disease (SD); b). histologically and/or cytologically confirmed diagnosis of ovarian cancer who have received 1 line of prior therapy consisting of at least 1 platinum agent and imaging evidence of disease progression within 6 months of the last dose of platinum-based chemotherapy,
- Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
Key exclusion criteria (21 listed)
- Patients with clinically symptomatic central nervous system metastases and/or carcinomatous meningitis,
- Patients who have previously failed to recover from adverse reactions to CTCAE V5.0 grade ≤ 1,
- Uncontrolled stable systemic disease with treatment，
- Any active autoimmune disease or documented autoimmune disease, or systemic syndrome previously requiring systemic steroids or immunosuppressive drugs，
- Patients who require systemic corticosteroids (at doses equivalent to > 10 mg prednisone/day) or other immunosuppressive drugs within 14 days before enrollment or during the study，
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 |
|---|---|---|
| PE0116,PE0105Also: PE0116 injection，PE0105 injection1. PE0116: 4-1BB Agonist Antibody Drug 2. PE0105: PD-1 Monoclonal Antibody Drug | Drug | PE0116+PE0105 |
Primary outcome
Dose limited toxicities evaluated by NCI-CTCAE v5.0
Time frame: From time of first dose to 21 days after the first dose.
Incidence of dose limited toxicities and associated dose of PE0105 and PE0116
Adverse events evaluated by NCI CTCAE v5.0
Time frame: From time of first dose to 90 days after the last dose.
Incidence of adverse events and associated dose of PE0105 and PE0116
Recommended Phase 2 Dose
Time frame: From time of first dose of the first patient to the last dose of the last patient in phase 1b..
Recommended dose for phase II clinical trial is explored through dose escalation in phase Ib clinical trial.
Objective response rate
Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
The proportion of subjects who have a Complete Response or Partial Response
2 secondary outcomes
Disease control rate
Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Plasma concentration of PE0116 and PE0105
Time frame: From one hour before the first dose to 90 days after the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Active, not recruitingPhase 2
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PE0116,PE0105 in people with Advanced Solid Tumors, run by Shanghai YingLi Pharmaceutical Co. Ltd..
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 9 inclusion and 21 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: opening soon, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanying Bao, PhD (86 21-51370693, hybao@yl-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicities evaluated by NCI-CTCAE v5.0 (time frame: From time of first dose to 21 days after the first dose.). The study lists 4 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 7 Sep 2023.