Advanced Solid TumorPhase 1NCT05780307
IMM2520, a PD-L1 and CD47 Bispecific Antibody in Patients With Advanced Solid Tumors
A Phase 1 study testing IMM2520 in people with Advanced Solid Tumor and Non-small Cell Lung Cancer, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in China.
Trial summary
This is a multi-center, open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM2520 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Non-small Cell Lung Cancer, Small Cell Lung Cancer
- What is being tested?
- IMM2520
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2023to 26 Oct 2025
- 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
- The subjects must voluntarily sign the informed consent, and the subjects are willing and able to comply with the visits, treatment plans, laboratory assessments, and other requirements of the study.
- Age ≥18 years old.
- Patients who were diagnosed as advanced or metastatic solid tumors histologically or cytologically have failed previous standard treatments. Patient requires the treatment in the opinion of the investigator.
- There is at least one measurable tumor lesion (refer to RECIST 1.1), defined as the longest measurable diameter of non-lymph node lesions by imaging (CT/MRI) ≥10 mm or the short diameter of a single pathological lymph node lesion ≥15 mm; at least one evaluable tumor lesion is needed in the dose-escalation phase.
- With an expected survival of ≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (ECOG score of 0-2 is allowed for cohort-expansion phase).
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- The organ or bone marrow function must meet the following laboratory criteria:
- Hematology: Absolute neutrophil count ≥ 1.5 × 109/L; hemoglobin ≥ 90 g/L; platelet count ≥ 75 × 109/L (without supportive treatment using granulocyte colony stimulating factor within 7 days before starting study treatment).
- Total serum bilirubin ≤ 1.5× upper limit of normal (ULN) (unless Gilbert syndrome is confirmed); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ALT and AST ≤ 5.0×ULN in case of liver metastasis.
- Prothrombin time (PT) ≤ 1.2 × ULN, activated partial thromboplastin time (APTT) ≤ 1.2 × ULN; international normalized ratio (INR) ≤ 1.2 (unless the subject is receiving warfarin therapy). If the subject is taking oral anticoagulant therapy, the dose should be stable for 2 weeks; if the subject is taking oral warfarin, the subject's INR must be ≤ 2.5 without hemorrhage.
- Creatinine clearance (Cr) > 30 mL/min (Cockcroft and Gault Equation).
- Left ventricular ejection fraction (LVEF) ≥ 40%;
- Previously treated toxicities have recovered to Grade 1 [as per NCI CTCAE 5.0 grading criteria] (except toxicities which have no safety risk at the discretion of the investigator, such as alopecia, neurotoxicity ≤ Grade 2 caused by chemotherapeutic drugs, etc.).
- Females with childbearing potentials must be tested negative for serum pregnancy test during the screening period before receiving the first administration of IMM2520; any female patient with childbearing potential must agree to take effective contraceptive measures during the entire study and within 3 months after study completion. A patient is considered to have childbearing potential if he/she is biologically capable of having children and has a heterosexual sex life.
Who cannot join
- A subject meeting any of the following criteria must be excluded from the study.
- Subjects are enrolled into another clinical study continuously, unless it is an observational, non-interfering clinical study or in the follow-up period of an interfering study.
- Treatment with the last systemic chemotherapy within 3 weeks; treatment with hormone therapy and small-molecule target therapy within 2 weeks; palliative radiation treatment for non-target lesions within 2 weeks; treatment with non-specific immunomodulatory therapy within 2 weeks prior to the first administration.
- Subjects with active central nervous system (CNS) metastases (Subjects with stable treated central nervous system [CNS] lesions who are off corticosteroid therapy for at least 2 weeks are not considered active).
- Subjects who have received previous treatment with > 1 PD-1 or PD-L1 inhibitors, such as pembrolizumab, nivolumab, atezolizumab or durvalumab.
- Subjects who have received previous treatment with anti-CD47 monoclonal antibody fusion protein.
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- Subjects diagnosed with other malignancies within 2 years before the first dose with exceptions: a. cervical carcinoma in situ or basal or squamous cell carcinoma of the skin underwent radical resection; b. second primary carcinoma underwent radical resection and without recurrence within 5 years; c. double primary cancers that can benefit from this study in the opinion of the investigator.
- Subjects who received prior allogeneic hematopoietic stem cell transplant or other organ transplants with acute or chromic GVHD（graft versus host disease） requiring the long-term immunosuppressive therapy before 6 months of treatment.
- Subjects with active autoimmune diseases requiring systemic treatment (with glucocorticoids or immunosuppressive drugs) in the past 2 years with exceptions of hormone replacement therapy for thyroid disease, adrenal or pituitary insufficiency disease.
- Concurrent medical condition requiring systemic corticosteroids (prednisone daily dose > 20 mg or equivalent dose) within14 days prior to first dose of the investigational product.
- Subjects who underwent a major surgery within 4 weeks prior to the first dose or planned to undergo a major surgery in 3 months after receiving the investigational drug (excluding catheterization, peripherally inserted central catheter, etc.).
- Hypertension , pulmonary hypertension or unstable angina, which cannot be controlled by medication; treatment with myocardial infarction, bypass or stent surgery within 6 months prior to administration; a history of chronic heart failure rated by the New York Heart Association (NYHA) as grade 3-4; severe arrhythmia requiring treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia that, according to the judgment of the investigators, do not affect the study); QTcF > 470 msec; history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to enrollment;
- A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to the first administration.
- Subjects with diseases that may cause gastrointestinal bleeding or perforation;
- Concurrent interstitial lung disease (ILD) (except for radiation therapy-induced loco regional interstitial pneumonia), severe chronic obstructive pulmonary disease, severe pulmonary insufficiency.
- Subjects with thoracoabdominal or pericardial effusions that cannot be controlled by puncture and drainage and require repeated drainage or with significant symptoms.
- Subjects with uncontrollable serious active infection (such as sepsis, bacteremia, and viremia) within 4 weeks before the first administration, or subjects with any signs or symptoms of active infection within 2 weeks, or subjects requiring antibiotic treatment within 2 weeks (except for the preventive application of antibiotics); fever of unknown cause > 38.5℃ before the first dose (subjects with fever due to tumor can be included in the opinion of the subjects); active tuberculosis infection;
- A known history of serious allergy to PD-1/PD-L antibodies.
- Patients who received live attenuated vaccine within 4 weeks prior to the first dose of the investigational product, or plan to receive attenuated vaccine during the study.
- Patients with human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg) positive at screening, and HBV-DNA above the lower limit of measurement; HCV antibody positive at screening and HCV-RNA above the lower limit of measurement.
- Subjects with immune-related toxicity that leads to permanent drug discontinuation due to previous anti-tumor immunotherapy.
- History of psychiatric illness or substance abuse is likely to interfere with the ability to comply with protocol requirements or giving informed consent.
- Other situations where investigators believe they are inappropriate for participation in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affilated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Yuping Sun, PI, +86-0531-67627156, 13370582181@163.com
About this study
Official title: A Phase 1 Clinical Study to Evaluate IMM2520 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Advanced Solid Tumors
This is a multi-center, open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM2520 in subjects with advanced solid tumors.
Read the detailed description
IMM2520 is administered via intravenous infusion once week of cycle 1- 12 (4 weeks per cycle).
The accelerated titration method and the traditional "3+3" method will be adopted to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) in dose-escalation phase.
Once the RP2D is determined, Simon's two-stage design will be used to explore for each specific tumor cohort.adenocarcinoma/esophageal cancer, urothelial cancer, and/or others.
- Conditions
- Advanced Solid Tumor, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Breast Cancer, Squamous Cell Cancer of Head and Neck, Colorectal Cancer
- Being tested
- IMM2520
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM2520Drug
Also called IMM2520 is a recombinant bispecific monoclonal antibody with high affinity to the dual targets, PD-L1 and CD47
IMM2520 will be administered once a week intravenously at Day 1, Day8, Day 15 and Day 22 each cycle for up to 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IMM2520 in subjects with advanced solid tumors | Experimental | Dose-escalation phase: the dosing schedule of IMM2520 is 0.1 mg/kg, 0.4 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg and 6.0 mg/kg sequentially. Receives: Drug: IMM2520 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs, SAEs and DLT
Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs)
Measured: From 1st dose of IMM2520 through 30 days after last dose
MTD and RP2D
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of IMM2520 in subjects with advanced solid tumors.
Measured: From start of treatment to treatment termination visit, up to 48weeks
Overall Rate Response (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
Measured: When the last subject enrolled completes approximately 48 weeks of treatment
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who have a critical response (CR), partial response (PR) or disease stable (SD)
Measured: From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment
Duration of Response (DOR)
DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD).
Measured: From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment
Progression-free survival (PFS)
Defined as the duration from the start of treatment until tumor progression or death of any cause
Measured: From start of treatment to treatment termination visit, up to 48 weeks
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration observed in patients with IMM2520 dosed
Measured: 48 weeks of treatment cycles
time to maximum concentration (Tmax)
time to maximum concentration observed in patients with IMM2520 dosed
Measured: 48 weeks of treatment cycles
Anti-drug antibody (ADA)
To evaluate the immunogenicity of IMM2520 in patients with malignancies
Measured: 48 weeks of treatment cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start23 Mar 2023
- Primary completion10 Mar 2024 (estimated)
- Study completion26 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Model description
- This study is to observe the dose-limiting toxicity (DLT) of the patients and to determine the maximal tolerance dose(MTD) and recommended dose for expansion (RDE)
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Cancer Hospital and Institute
- Responsible party
- Sponsor
- Investigators
- YIXUAN YANG, MD, Study director, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780307
- Sponsor's protocol ID
- IMM2520-001
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate IMM2520 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05780307
- Acronym / sponsor ID
- IMM2520-001
- Conditions
- Advanced Solid Tumor, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Breast Cancer, Squamous Cell Cancer of Head and Neck, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Collaborators
- Shandong Cancer Hospital and Institute
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 26 Oct 2025 (estimated)
- First posted
- 22 Mar 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 multi-center, open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM2520 in subjects with advanced solid tumors.
Detailed description
IMM2520 is administered via intravenous infusion once week of cycle 1- 12 (4 weeks per cycle).
The accelerated titration method and the traditional "3+3" method will be adopted to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) in dose-escalation phase.
Once the RP2D is determined, Simon's two-stage design will be used to explore for each specific tumor cohort.adenocarcinoma/esophageal cancer, urothelial cancer, and/or others.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is to observe the dose-limiting toxicity (DLT) of the patients and to determine the maximal tolerance dose(MTD) and recommended dose for expansion (RDE)
| Arm | Type | Receives |
|---|---|---|
| IMM2520 in subjects with advanced solid tumors | Experimental | Drug: IMM2520Dose-escalation phase: the dosing schedule of IMM2520 is 0.1 mg/kg, 0.4 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg and 6.0 mg/kg sequentially. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The subjects must voluntarily sign the informed consent, and the subjects are willing and able to comply with the visits, treatment plans, laboratory assessments, and other requirements of the study.
- Age ≥18 years old.
- Patients who were diagnosed as advanced or metastatic solid tumors histologically or cytologically have failed previous standard treatments. Patient requires the treatment in the opinion of the investigator.
- There is at least one measurable tumor lesion (refer to RECIST 1.1), defined as the longest measurable diameter of non-lymph node lesions by imaging (CT/MRI) ≥10 mm or the short diameter of a single pathological lymph node lesion ≥15 mm; at least one evaluable tumor lesion is needed in the dose-escalation phase.
- With an expected survival of ≥ 12 weeks.
Key exclusion criteria (23 listed)
- A subject meeting any of the following criteria must be excluded from the study.
- Subjects are enrolled into another clinical study continuously, unless it is an observational, non-interfering clinical study or in the follow-up period of an interfering study.
- Treatment with the last systemic chemotherapy within 3 weeks; treatment with hormone therapy and small-molecule target therapy within 2 weeks; palliative radiation treatment for non-target lesions within 2 weeks; treatment with non-specific immunomodulatory therapy within 2 weeks prior to the first administration.
- Subjects with active central nervous system (CNS) metastases (Subjects with stable treated central nervous system [CNS] lesions who are off corticosteroid therapy for at least 2 weeks are not considered active).
- Subjects who have received previous treatment with > 1 PD-1 or PD-L1 inhibitors, such as pembrolizumab, nivolumab, atezolizumab or durvalumab.
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 |
|---|---|---|
| IMM2520Also: IMM2520 is a recombinant bispecific monoclonal antibody with high affinity to the dual targets, PD-L1 and CD47IMM2520 will be administered once a week intravenously at Day 1, Day8, Day 15 and Day 22 each cycle for up to 48 weeks. | Drug | IMM2520 in subjects with advanced solid tumors |
Primary outcome
AEs, SAEs and DLT
Time frame: From 1st dose of IMM2520 through 30 days after last dose
Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs)
MTD and RP2D
Time frame: From start of treatment to treatment termination visit, up to 48weeks
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of IMM2520 in subjects with advanced solid tumors.
Overall Rate Response (ORR)
Time frame: When the last subject enrolled completes approximately 48 weeks of treatment
ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
Disease Control Rate (DCR)
Time frame: From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment
DCR is defined as the proportion of participants who have a critical response (CR), partial response (PR) or disease stable (SD)
Duration of Response (DOR)
Time frame: From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment
DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD).
Progression-free survival (PFS)
Time frame: From start of treatment to treatment termination visit, up to 48 weeks
Defined as the duration from the start of treatment until tumor progression or death of any cause
3 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: 48 weeks of treatment cycles
time to maximum concentration (Tmax)
Time frame: 48 weeks of treatment cycles
Anti-drug antibody (ADA)
Time frame: 48 weeks of treatment cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 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.
YIXUAN YANG, MD study director
Clinical Development
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 IMM2520 in people with Advanced Solid Tumor and Non-small Cell Lung Cancer, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 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 14 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 7 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Zhou, MM (13621857739, ping.zhou@immuneonco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs, SAEs and DLT (time frame: From 1st dose of IMM2520 through 30 days after last dose). The study lists 6 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 Jun 2023.