Locally Advanced/Metastatic Solid TumorsPhase 1NCT05800249
PE0116 Injection in Treatment of Patients With Advanced Solid Tumours
A Phase 1 study testing PE0116 in people with Locally Advanced/Metastatic Solid Tumors, run by Shanghai HyaMab Biotech Co.,Ltd. at 1 site in China.
Trial summary
This is a Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 Injection in Treatment of Patients with Advanced Solid Tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced/Metastatic Solid Tumors
- What is being tested?
- PE0116
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2021to 16 Jun 2023
- Phase
- Phase 1
- 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
- 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, age ≥ 18 years;
- Patients who have histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent solid tumors that are refractory to or intolerable with standard treatment, or for which no standard effective treatment is available;
- 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;
- Patients who have at least one evaluable lesion in Phase Ia study, and have measurable lesions in Phase Ib (according to RECIST v1.1). Tumor lesions in the area of prior radiotherapy (or other local therapy) with unequivocal progression after radiotherapy as confirmed by imaging can be considered as measurable lesions;
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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, with the following exceptions: a)≥ 6 weeks after receiving nitrosourea or mitomycin C before the first dose of study drug; b)≥ 2 weeks or 5 half-life periods (whichever is longer) of oral fluorouracils and small molecule targeted agents before the first dose of study drug; c)≥ 2 weeks after receiving traditional Chinese medicine with anti-tumor indications before the first dose of study drug；
- Patients who have suitable organ and hematopoietic function without severe heart, lung, liver, renal dysfunction and immunodeficiency according to the following laboratory tests: a)Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; b)Absolute white blood cell count (WBC) ≥ 3.0 × 109/L; c)Platelets ≥ 75 x 109/L; d)Hemoglobin ≥ 90 g/L; e)Serum creatinine ≤ 1.5 times the upper limit of normal (ULN); f)AST and ALT ≤ 2.5 × ULN, or ≤ 5 × ULN for patients with liver cancer or metastases to liver; g) Serum total bilirubin (TBIL) ≤ 1.5 × ULN; h)International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APPT) ≤ 1.5 × ULN (except for patients receiving anticoagulant therapy); i)Myocardial enzyme CK and CKMB test values are within the normal range, or mildly abnormal but judged by the investigator to be suitable for enrollment; j)Thyroid function (FT3, FT4, and TSH) test values are within the normal range, or mildly abnormal but judged by the investigator to be suitable for enrollment.
- Male subjects and female subjects 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
- Subjects who have central nervous system metastasis with clinical symptoms (e.g., brain edema, hormone intervention required, or progression of brain metastasis) and/or carcinomatous meningitis. However, subjects who have received prior treatment for brain or meningeal metastases can be included if they have remained stable clinically for at least 2 months and systemic hormone therapy (prednisone at a dose of > 10 mg/day or other hormone at an equivalent dose) has been discontinued for more than 4 weeks;
- Subjects who fail to recover from adverse reactions of prior therapies to ≤ CTCAE V5.0 Grade 1. (Patients with residual alopecia, chromatosis and peripheral neurotoxicity that has recovered to ≤ CTCAE Grade 2, and with long-term toxicity caused by radiotherapy that cannot recover as judged by the investigator may be included);
- Subjects with systemic diseases that have not been stably controlled after treatment, such as history of severe cardiovascular and cerebrovascular diseases, diabetes mellitus, hypertension, etc.;
- Subjects who have any active auto-immune disease or evidence of auto-immune disease, or systemic syndrome previously requiring treatment with systemic steroids or immunosuppressive drugs. (Patients with inactive vitiligo, psoriasis and post-treatment childhood asthma/atopy within 2 years, or thyroid disease that has been controlled with alternative therapy/non-immunosuppression may be included);
- For subjects requiring systemic treatment with corticosteroids (at doses equivalent to > 10 mg prednisone/day) or other immunosuppressive agents within 14 days prior to enrollment or during the study period, enrollment is allowed under the following situations: a)Subjects are allowed to use topical or inhaled glucocorticoids; b)Short-term (≤ 7 days) use of glucocorticoids for the prophylaxis or treatment of non-autoimmune allergic diseases is permitted;
- Subjects who have a history of infection with human immunodeficiency virus, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation, or a history of stem cell transplantation;
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- Patients with tuberculosis that is active at screening;
- Patients with active chronic hepatitis B or active hepatitis C. Patients as hepatitis B virus carriers, and with stable hepatitis B after drug treatment (DNA titers should not be higher than 500 copies/mL), and cured hepatitis C (HCV RNA test results are required to be below the lower limit of the testing site) can be enrolled;
- Patients who have received treatment with anti-4-1BB targeting drugs;
- Patients with a known history of severe allergic reactions (CTCAE v5.0 ≥ Grade 3) to macromolecular protein preparations/monoclonal antibodies, or to any component of the study drug;
- Patients who are expected to have major surgery during the study, including the 28-day screening period;
- Patients with serious infection within 4 weeks prior to the first dose, or with active infection requiring oral or intravenous antibiotics within the first 2 weeks;
- Patients who have participated in clinical trial of another drug within 4 weeks prior to enrollment and enrolled for drug treatment, or are less than 4 weeks after end of treatment (EOT);
- Patients who have a history of alcohol abuse, drug addiction or drug abuse in the past 1 year;
- Patients who used live attenuated vaccine within 4 weeks prior to the first dose or plan to use such vaccine during the course of the study;
- Patients with a previous history of definite neurological or mental disorders, including epilepsy, dementia and poor compliance;
- Pregnant or breastfeeding women; eligible patients (males and females) of childbearing potential who do not agree to use a reliable method of contraception (hormonal or barrier method, or abstinence) during the trial and for at least 3 months after the last dose; and female patients of childbearing potential who have a positive blood or urine pregnancy test within 7 days prior to enrollment.
- Subjects who, in the opinion of the investigator, are not suitable for the study for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 Injection in Treatment of Patients With Advanced Solid Tumor
This is a Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 Injection in Treatment of Patients with Advanced Solid Tumor.
- Conditions
- Locally Advanced/Metastatic Solid Tumors
- Being tested
- PE0116
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PE0116Drug
Also called Recombinant Anti-4-1BB Human Monoclonal Antibody Injection
This is a Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 Injection in Treatment of Patients with Advanced Solid Tumor
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | A total of 9 dose groups are expected to be evaluated in Phase Ia: 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 2 mg/kg, 3 mg/kg, 5 mg/kg, 6 mg/kg, and 10 mg/kg. One subject will be enrolled in the starting dose group of 0.03 mg/kg (if any ≥ Grade 2 dose-related adverse event is observed in this group during the DLT observation period, the group will be changed to the "3 + 3" method), and 3 or 6 subjects will be enrolled in each of other dose groups. The first 2 subjects in the same dose group shall receive the first dose at an interval of at least 48 hours to avoid acute hypersensitivity reactions, and the specific interval shall be determined by the investigator based on the safety assessment of subjects in the previous dose group. Ultimately, the sponsor and the investigator will determine whether an increase in dose group or in a specific fixed dose is required according to the actual situation of the trial. Receives: Drug: PE0116 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Drug Limited Toxicities (DLTs)
To assess by the occurrence of Drug Limited Toxicities (DLTs)
Measured: From Time of First dose through DLT observation period, 28 days
Incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs).
To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)
Measured: From the start of treatment until up to 90 days after the last dose of study drug
Number of patients with changes in laboratory parameters from baseline
To assess safety of PE0116
Measured: From the start of treatment until up to 30(±7) days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start8 Mar 2021
- Primary completion2 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced/Metastatic 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai HyaMab Biotech Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800249
- Sponsor's protocol ID
- PE0116-I
- Status last verified
- Dec 2023
- First submitted
- 22 Mar 2023
- Last updated
- 12 Dec 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 Injection in Treatment of Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05800249
- Acronym / sponsor ID
- PE0116-I
- Conditions
- Locally Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Shanghai HyaMab Biotech Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 5 Apr 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 is a Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 Injection in Treatment of Patients with Advanced Solid Tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: PE0116A total of 9 dose groups are expected to be evaluated in Phase Ia: 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 2 mg/kg, 3 mg/kg, 5 mg/kg, 6 mg/kg, and 10 mg/kg. One subject will be enrolled in the starting dose group of 0.03 mg/kg (if any ≥ Grade 2 dose-related adverse event is observed in this group during the DLT observation period, the group will be changed to the "3 + 3" method), and 3 or 6 subjects will be enrolled in each of other dose groups. The first 2 subjects in the same dose group shall receive the first dose at an interval of at least 48 hours to avoid acute hypersensitivity reactions, and the specific interval shall be determined by the investigator based on the safety assessment of subjects in the previous dose group. Ultimately, the sponsor and the investigator will determine whether an increase in dose group or in a specific fixed dose is required according to the actual situation of the trial. |
Who may qualify
- Ages
- 18 years and older
- 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, age ≥ 18 years;
- Patients who have histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent solid tumors that are refractory to or intolerable with standard treatment, or for which no standard effective treatment is available;
- 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;
Key exclusion criteria (18 listed)
- Subjects who have central nervous system metastasis with clinical symptoms (e.g., brain edema, hormone intervention required, or progression of brain metastasis) and/or carcinomatous meningitis. However, subjects who have received prior treatment for brain or meningeal metastases can be included if they have remained stable clinically for at least 2 months and systemic hormone therapy (prednisone at a dose of > 10 mg/day or other hormone at an equivalent dose) has been discontinued for more than 4 weeks;
- Subjects who fail to recover from adverse reactions of prior therapies to ≤ CTCAE V5.0 Grade 1. (Patients with residual alopecia, chromatosis and peripheral neurotoxicity that has recovered to ≤ CTCAE Grade 2, and with long-term toxicity caused by radiotherapy that cannot recover as judged by the investigator may be included);
- Subjects with systemic diseases that have not been stably controlled after treatment, such as history of severe cardiovascular and cerebrovascular diseases, diabetes mellitus, hypertension, etc.;
- Subjects who have any active auto-immune disease or evidence of auto-immune disease, or systemic syndrome previously requiring treatment with systemic steroids or immunosuppressive drugs. (Patients with inactive vitiligo, psoriasis and post-treatment childhood asthma/atopy within 2 years, or thyroid disease that has been controlled with alternative therapy/non-immunosuppression may be included);
- For subjects requiring systemic treatment with corticosteroids (at doses equivalent to > 10 mg prednisone/day) or other immunosuppressive agents within 14 days prior to enrollment or during the study period, enrollment is allowed under the following situations: a)Subjects are allowed to use topical or inhaled glucocorticoids; b)Short-term (≤ 7 days) use of glucocorticoids for the prophylaxis or treatment of non-autoimmune allergic diseases is permitted;
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 |
|---|---|---|
| PE0116Also: Recombinant Anti-4-1BB Human Monoclonal Antibody InjectionThis is a Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 Injection in Treatment of Patients with Advanced Solid Tumor | Drug | Dose Escalation |
Primary outcome
Occurrence of Drug Limited Toxicities (DLTs)
Time frame: From Time of First dose through DLT observation period, 28 days
To assess by the occurrence of Drug Limited Toxicities (DLTs)
Incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs).
Time frame: From the start of treatment until up to 90 days after the last dose of study drug
To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)
Number of patients with changes in laboratory parameters from baseline
Time frame: From the start of treatment until up to 30(±7) days after the last dose of study drug
To assess safety of PE0116
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 2023.
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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 study testing PE0116 in people with Locally Advanced/Metastatic Solid Tumors, run by Shanghai HyaMab Biotech Co.,Ltd. at 1 site in China.
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 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 2023. 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 China. 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 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.
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?
Occurrence of Drug Limited Toxicities (DLTs) (time frame: From Time of First dose through DLT observation period, 28 days). The study lists 3 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 2023.