Pheochromocytoma/ParagangliomaPhase 2NCT06683846
Ivonescimab in the Treatment of Multiple Advanced Tumors
A Phase 2 study testing Ivocizumab in people with Pheochromocytoma/Paraganglioma and Rhabdomyosarcoma, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Ivonescimab works to treat advanced rare tumors including cohort 1: PAGET's disease of scrotum with infiltrating sweat gland carcinoma. cohort 2: Metastatic paraganglioma and pheochromocytoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytoma/Paraganglioma, Rhabdomyosarcoma, Paget Disease, Extramammary
- What is being tested?
- Ivocizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 30 Nov 2027
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals able to understand and give written informed consent.
- Histologically or cytologically confirmed cancer of one of the following types:
- PAGET's disease of scrotum with infiltrating sweat gland carcinoma Paraganglioma Pheochromocytom, Renal angiomyolipoma Malignant perivascular epithelioid cell tumor, Rhabdomyosarcom Other sarcoma rather than rhabdomyosarcom
- Stage IV disease
- Adequate performance status (ECOG 0-2)
- Expected survival ≥ 3 months.
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- Measurable disease by CT or MRI, Or lesions with skin infiltration.
- Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
- Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
- Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN.
- Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.
- Ability to comply with research visit schedules and other protocol requirements.
Who cannot join
- With any severe and/or uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); (2) poor control of diabetes (fasting blood sugar [FBG] >10mmol/L);
- ≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification); (3)active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment (≥CTCAE 2-level infection), including tuberculosis infection; A history of active tuberculosis; (4)Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage;
- With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU/ml or ≥10^4 copies/ml; HCV reference: HCV RNA≥2000 IU/ml or ≥10^4 copies/ml; after nucleoside analog antiviral therapy below the above standard, can be included; chronic hepatitis B virus carrier, HBV DNA<10^4 IU/ml, must be treated with antiviral drugs during the trial period to be eligible for enrollment);
- History of immunodeficiency, including HIV positive or subjects with other acquired or congenital immunodeficiency diseases;
- Active autoimmune disease requiring systemic treatment within the past two years, or subjects with an autoimmune disease that the investigator judges may recur or is planned for treatment; except: non-systemic treatment of skin diseases (e.g. vitiligo, alopecia, psoriasis or eczema); autoimmune thyroiditis-induced hypothyroidism requiring stable dose replacement therapy with hormones; 13. Subjects who have experienced severe hypersensitivity reactions after using monoclonal antibodies; individuals who are known to be allergic to the active ingredients or excipients of the study drug;
- Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry;
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- Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study;
- History of severe allergies;
- At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy;
- History of substance abuse with an inability to abstain or a history of mental illness;
- Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study, or who, in the opinion of the investigator, have other reasons not to be enrolled; Subjects who have a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of seizure susceptibility;
- Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study (such as severe diabetes, thyroid disorders, and mental illness), or who have a serious and/or unstable medical, psychological, or other condition (including laboratory abnormalities) that would affect the subject's safety or the subject's ability to provide informed consent, or who have any condition that would affect the study protocol and follow-up plan, including psychological, familial, social, or geographic factors;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Hongxia Wang, Doctor, 021-64175590, whx365@126.com
About this study
Official title: Ivonescimab (PD-1/VEGF Bispecpecial Antibody) in the Treatment of Multiple Advanced Tumors: a Multi-cohort, Multi-center, Single-arm Phase II Study
The goal of this clinical trial is to learn if Ivonescimab works to treat advanced rare tumors including cohort 1: PAGET's disease of scrotum with infiltrating sweat gland carcinoma. cohort 2: Metastatic paraganglioma and pheochromocytoma. cohort 3: Metastatic renal angiomyolipoma and malignant perivascular epithelioid cell tumor.
cohort 4: Rhabdomyosarcoma and Ewing's sarcoma cohort 5: Collecting duct carcinoma cohort 6: Urachal carcinoma. cohort 7: Neuroendocrine cancer. cohort 8: Basal cell carcinoma and sarcomatoid carcinoma. cohort 9: Penile cancer. cohort 10: Adrenal cortical cancer. cohort 11: Metastatic germ cell tumors, failure of standard cisplatin based therapy (mostly testicular cancer).
Read more
cohort 12: Non-clear cell renal carcinoma (including renal papillary renal carcinoma); Renal cancer cannot be classified).
cohort 13: Non-clear cell renal carcinoma (including chromophobe renal carcinoma) cohort 14: Other rare tumors that cannot be classified (such as testicular reticulum adenocarcinoma, etc.).
cohort 15: Prostate cancer. cohort 16: Clear cell renal carcinoma. (16.1: received PD-1; 16.2: no PD-1 received) cohort 17: Urothelial carcinoma. cohort 18: Kidney cancer with brain metastases. cohort 19: Brain metastases of urothelial carcinoma. cohort 20: Rare tumors with brain metastases.
It will also learn about the safety of Ivonescimab. The main questions it aims to answer are:
Does Ivonescimab improve the objective response rate and prolong the survival of participants? What medical problems do participants have when taking Ivonescimab?
Participants will:
Receive Ivonescimab 20mg/kg intravenously every 21 days until disease progression, intolerable toxicity, or full 2 years of treatment, whichever occurs first.
Be performed imaging evaluation according to RECIST 1.1 every 9 weeks for 1 year of treatment and every 12 weeks after 1 year Be recorded any adverse events in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria
Read the detailed description
This is a prospective, multi-cohort phase II study. Primary objectives is to evaluate the objective response rate (ORR) of Ivonescimab in the treatment of multiple rare advanced tumors. Secondary objectives is to evaluate the imaging progression-free survival (PFS), overall survival (OS), quality of life (QoL), and safety in the treatment of multiple rare advanced tumors with Ivonescimab.
A total of 20 cohorts were included:
cohort 1: PAGET's disease of scrotum with infiltrating sweat gland carcinoma. cohort 2: Metastatic paraganglioma and pheochromocytoma. cohort 3: Metastatic renal angiomyolipoma and malignant perivascular epithelioid cell tumor.
cohort 4: Rhabdomyosarcoma and Ewing's sarcoma cohort 5: Collecting duct carcinoma cohort 6: Urachal carcinoma. cohort 7: Neuroendocrine cancer. cohort 8: Basal cell carcinoma and sarcomatoid carcinoma. cohort 9: Penile cancer. cohort 10: Adrenal cortical cancer. cohort 11: Metastatic germ cell tumors, failure of standard cisplatin based therapy (mostly testicular cancer).
cohort 12: Non-clear cell renal carcinoma (including renal papillary renal carcinoma); Renal cancer cannot be classified).
cohort 13: Non-clear cell renal carcinoma (including chromophobe renal carcinoma) cohort 14: Other rare tumors that cannot be classified (such as testicular reticulum adenocarcinoma, etc.).
cohort 15: Prostate cancer. cohort 16: Clear cell renal carcinoma. (16.1: received PD-1; 16.2: no PD-1 received) cohort 17: Urothelial carcinoma. cohort 18: Kidney cancer with brain metastases. cohort 19: Brain metastases of urothelial carcinoma. cohort 20: Rare tumors with brain metastases. Sample size: using one stage binomial design with power 80% and unilateral alpha value 0.1, it is expected that less than 5% will be ineffective, while 20% will be effective. Considering 10% loss of follow-up, 19 cases will be required. Calculate 20 people per cohort. A total of 400 patients were enrolled.
The study included a screening period (participants signed informed consent no more than 28 days before the first treatment in the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging confirmation of disease progression, failure to tolerate adverse effects after dose adjustment, or early withdrawal for any reason), and a follow-up period (including end-of-treatment visits, safety visits, and survival follow-up).
Screening period: Participants are required to undergo a screening period within 28 days prior to the study's first treatment to determine eligibility.
Duration of treatment: Patients were treated with ebraxizumab (20mg/kg Q3W every 3 weeks) until disease progression or intolerability of toxicity, or ebraxizumab for 2 years. Reviews were performed every 9 weeks for 1 year of treatment and every 12 weeks after 1 year.
Follow-up period: The safety follow-up period began after the last study treatment, and was followed up once on the 30th day (±7 days). Subjects should go to the research center for the examination of vital signs, physical examination, laboratory examination and other protocol requirements, and evaluate AE, concomitant medication and concomitant treatment.
After the end of the safety follow-up period, the subjects entered the 1-year survival follow-up period, which was conducted every 3 months. They could be visited by telephone follow-up and other effective ways to collect survival information and follow-up treatment information. Survival follow-up lasted until death, loss of follow-up, withdrawal of informed consent, or investigator termination of the study.
Administration regimen: Ivonescimab (AK112), 20mg/kg, 21 days in a cycle, with not less than 90 minutes (±10 minutes) of intravenous infusion, the infusion time can be extended to a maximum of 240 minutes, continuous administration until disease progression, intolerable toxicity, or 2 years of treatment.
Dose adjustment of AK112 is not permitted during treatment, but delayed dosing is permitted for up to 12 weeks (since the last dosing time) if AK112 is discontinued for more than 12 weeks due to glucocorticoid administration for irAE, or if there is an AE that may be unrelated or unrelated to AK112 due to treatment. In both cases that led to the suspension of AK112 for more than 12 weeks, the investigators determined that the patient would benefit from continued treatment and could be allowed to delay treatment for more than 12 weeks.
- Conditions
- Pheochromocytoma/Paraganglioma, Rhabdomyosarcoma, Paget Disease, Extramammary, Renal Angiomyolipoma, Perivascular Epithelioid Cell Tumor, Malignant, Sarcoma
- Being tested
- Ivocizumab
- Keywords
- rare tumor, Ivocizumab, immunotherapy
- Medical subject headings
- Pheochromocytoma, Paraganglioma, Rhabdomyosarcoma, Paget Disease, Extramammary, Angiomyolipoma, Perivascular Epithelioid Cell Neoplasms, Sarcoma, Urachal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvocizumabDrug
Administered via intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab (20mg/kg）in rare tumors | Experimental | Participants will receive Ivonescimab 20mg/kg of body weight via intravenous (IV) infusion on Days 1 of a 21-day treatment cycle until disease progression or unacceptable toxicity, or full 2 years of treatment, whichever occurs first. Receives: Drug: Ivocizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR was defined as the proportion of patients who achieved either a complete response (CR) or a partial response (PR) based on the investigator's assessment (RECIST v1.1) that was confirmed by a subsequent scan ≥4 weeks after initial CR/PR.
Measured: 12 weeks
Secondary outcomes (3)
Progression-free survival(PFS)
PFS was defined as the time between the enrollment and either RECIST1.1-defined progressive disease or death due to any cause, whichever occurred first.
Measured: 1 year
Overall survival (OS)
OS was defined as the time between the enrollment and death due to any cause.
Measured: 2 years
Patient-Reported Quality-of-Life(QoL)
Patient-Reported QoL was evaluated according to the European Organization for Research and Treatment of Cancer QOL Core Questionnaire 30 (EORTC QLQ-30) questionaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start20 Nov 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pheochromocytoma/ParagangliomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm, multi-cohort
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
- Investigators
- Hongxia Wang, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683846
- Sponsor's protocol ID
- AK112-US-01
- Status last verified
- Aug 2025
- First submitted
- 8 Nov 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivonescimab (PD-1/VEGF Bispecpecial Antibody) in the Treatment of Multiple Advanced Tumors: a Multi-cohort, Multi-center, Single-arm Phase II Study
- ClinicalTrials.gov ID
- NCT06683846
- Acronym / sponsor ID
- AK112-US-01
- Conditions
- Pheochromocytoma/Paraganglioma, Rhabdomyosarcoma, Paget Disease, Extramammary, Renal Angiomyolipoma, Perivascular Epithelioid Cell Tumor, Malignant, Sarcoma
- Keywords
- rare tumor, Ivocizumab, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 12 Nov 2024 (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.
The goal of this clinical trial is to learn if Ivonescimab works to treat advanced rare tumors including cohort 1: PAGET's disease of scrotum with infiltrating sweat gland carcinoma. cohort 2: Metastatic paraganglioma and pheochromocytoma. cohort 3: Metastatic renal angiomyolipoma and malignant perivascular epithelioid cell tumor.
cohort 4: Rhabdomyosarcoma and Ewing's sarcoma cohort 5: Collecting duct carcinoma cohort 6: Urachal carcinoma. cohort 7: Neuroendocrine cancer. cohort 8: Basal cell carcinoma and sarcomatoid carcinoma. cohort 9: Penile cancer. cohort 10: Adrenal cortical cancer. cohort 11: Metastatic germ cell tumors, failure of standard cisplatin based therapy (mostly testicular cancer).
cohort 12: Non-clear cell renal carcinoma (including renal papillary renal carcinoma); Renal cancer cannot be classified).
cohort 13: Non-clear cell renal carcinoma (including chromophobe renal carcinoma) cohort 14: Other rare tumors that cannot be classified (such as testicular reticulum adenocarcinoma, etc.).
cohort 15: Prostate cancer. cohort 16: Clear cell renal carcinoma. (16.1: received PD-1; 16.2: no PD-1 received) cohort 17: Urothelial carcinoma. cohort 18: Kidney cancer with brain metastases. cohort 19: Brain metastases of urothelial carcinoma. cohort 20: Rare tumors with brain metastases.
It will also learn about the safety of Ivonescimab. The main questions it aims to answer are:
Does Ivonescimab improve the objective response rate and prolong the survival of participants? What medical problems do participants have when taking Ivonescimab?
Participants will:
Receive Ivonescimab 20mg/kg intravenously every 21 days until disease progression, intolerable toxicity, or full 2 years of treatment, whichever occurs first.
Be performed imaging evaluation according to RECIST 1.1 every 9 weeks for 1 year of treatment and every 12 weeks after 1 year Be recorded any adverse events in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria
Detailed description
This is a prospective, multi-cohort phase II study. Primary objectives is to evaluate the objective response rate (ORR) of Ivonescimab in the treatment of multiple rare advanced tumors. Secondary objectives is to evaluate the imaging progression-free survival (PFS), overall survival (OS), quality of life (QoL), and safety in the treatment of multiple rare advanced tumors with Ivonescimab.
A total of 20 cohorts were included:
cohort 1: PAGET's disease of scrotum with infiltrating sweat gland carcinoma. cohort 2: Metastatic paraganglioma and pheochromocytoma. cohort 3: Metastatic renal angiomyolipoma and malignant perivascular epithelioid cell tumor.
cohort 4: Rhabdomyosarcoma and Ewing's sarcoma cohort 5: Collecting duct carcinoma cohort 6: Urachal carcinoma. cohort 7: Neuroendocrine cancer. cohort 8: Basal cell carcinoma and sarcomatoid carcinoma. cohort 9: Penile cancer. cohort 10: Adrenal cortical cancer. cohort 11: Metastatic germ cell tumors, failure of standard cisplatin based therapy (mostly testicular cancer).
cohort 12: Non-clear cell renal carcinoma (including renal papillary renal carcinoma); Renal cancer cannot be classified).
cohort 13: Non-clear cell renal carcinoma (including chromophobe renal carcinoma) cohort 14: Other rare tumors that cannot be classified (such as testicular reticulum adenocarcinoma, etc.).
cohort 15: Prostate cancer. cohort 16: Clear cell renal carcinoma. (16.1: received PD-1; 16.2: no PD-1 received) cohort 17: Urothelial carcinoma. cohort 18: Kidney cancer with brain metastases. cohort 19: Brain metastases of urothelial carcinoma. cohort 20: Rare tumors with brain metastases. Sample size: using one stage binomial design with power 80% and unilateral alpha value 0.1, it is expected that less than 5% will be ineffective, while 20% will be effective. Considering 10% loss of follow-up, 19 cases will be required. Calculate 20 people per cohort. A total of 400 patients were enrolled.
The study included a screening period (participants signed informed consent no more than 28 days before the first treatment in the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging confirmation of disease progression, failure to tolerate adverse effects after dose adjustment, or early withdrawal for any reason), and a follow-up period (including end-of-treatment visits, safety visits, and survival follow-up).
Screening period: Participants are required to undergo a screening period within 28 days prior to the study's first treatment to determine eligibility.
Duration of treatment: Patients were treated with ebraxizumab (20mg/kg Q3W every 3 weeks) until disease progression or intolerability of toxicity, or ebraxizumab for 2 years. Reviews were performed every 9 weeks for 1 year of treatment and every 12 weeks after 1 year.
Follow-up period: The safety follow-up period began after the last study treatment, and was followed up once on the 30th day (±7 days). Subjects should go to the research center for the examination of vital signs, physical examination, laboratory examination and other protocol requirements, and evaluate AE, concomitant medication and concomitant treatment.
After the end of the safety follow-up period, the subjects entered the 1-year survival follow-up period, which was conducted every 3 months. They could be visited by telephone follow-up and other effective ways to collect survival information and follow-up treatment information. Survival follow-up lasted until death, loss of follow-up, withdrawal of informed consent, or investigator termination of the study.
Administration regimen: Ivonescimab (AK112), 20mg/kg, 21 days in a cycle, with not less than 90 minutes (±10 minutes) of intravenous infusion, the infusion time can be extended to a maximum of 240 minutes, continuous administration until disease progression, intolerable toxicity, or 2 years of treatment.
Dose adjustment of AK112 is not permitted during treatment, but delayed dosing is permitted for up to 12 weeks (since the last dosing time) if AK112 is discontinued for more than 12 weeks due to glucocorticoid administration for irAE, or if there is an AE that may be unrelated or unrelated to AK112 due to treatment. In both cases that led to the suspension of AK112 for more than 12 weeks, the investigators determined that the patient would benefit from continued treatment and could be allowed to delay treatment for more than 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm, multi-cohort
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab (20mg/kg）in rare tumors | Experimental | Drug: IvocizumabParticipants will receive Ivonescimab 20mg/kg of body weight via intravenous (IV) infusion on Days 1 of a 21-day treatment cycle until disease progression or unacceptable toxicity, or full 2 years of treatment, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Individuals able to understand and give written informed consent.
- Histologically or cytologically confirmed cancer of one of the following types:
- PAGET's disease of scrotum with infiltrating sweat gland carcinoma Paraganglioma Pheochromocytom, Renal angiomyolipoma Malignant perivascular epithelioid cell tumor, Rhabdomyosarcom Other sarcoma rather than rhabdomyosarcom
- Stage IV disease
- Adequate performance status (ECOG 0-2)
Key exclusion criteria (12 listed)
- With any severe and/or uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); (2) poor control of diabetes (fasting blood sugar [FBG] >10mmol/L);
- ≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification); (3)active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment (≥CTCAE 2-level infection), including tuberculosis infection; A history of active tuberculosis; (4)Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage;
- With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU/ml or ≥10^4 copies/ml; HCV reference: HCV RNA≥2000 IU/ml or ≥10^4 copies/ml; after nucleoside analog antiviral therapy below the above standard, can be included; chronic hepatitis B virus carrier, HBV DNA<10^4 IU/ml, must be treated with antiviral drugs during the trial period to be eligible for enrollment);
- History of immunodeficiency, including HIV positive or subjects with other acquired or congenital immunodeficiency diseases;
- Active autoimmune disease requiring systemic treatment within the past two years, or subjects with an autoimmune disease that the investigator judges may recur or is planned for treatment; except: non-systemic treatment of skin diseases (e.g. vitiligo, alopecia, psoriasis or eczema); autoimmune thyroiditis-induced hypothyroidism requiring stable dose replacement therapy with hormones; 13. Subjects who have experienced severe hypersensitivity reactions after using monoclonal antibodies; individuals who are known to be allergic to the active ingredients or excipients of the study drug;
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 |
|---|---|---|
| IvocizumabAdministered via intravenous (IV) infusion | Drug | Ivonescimab (20mg/kg）in rare tumors |
Primary outcome
Objective response rate (ORR)
Time frame: 12 weeks
ORR was defined as the proportion of patients who achieved either a complete response (CR) or a partial response (PR) based on the investigator's assessment (RECIST v1.1) that was confirmed by a subsequent scan ≥4 weeks after initial CR/PR.
3 secondary outcomes
Progression-free survival(PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 years
Patient-Reported Quality-of-Life(QoL)
Time frame: 1 year
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 24 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Hongxia Wang, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivocizumab in people with Pheochromocytoma/Paraganglioma and Rhabdomyosarcoma, run by Fudan University 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 12 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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 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 Sheng Zhang, Doctor (021-64175590, wozhangsheng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 12 weeks). 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 24 Aug 2025.