Solid Tumor CancerPhase 1NCT07584954
Phase I, Open-labeled, Dose-escalation, Dose-expansion Study Evaluating the Safety, Tolerance, Pharmacokinetics, and Activity of IUAb190708 in Patients With Advanced or Recurrent Solid Tumors
A Phase 1 study testing IUAb190708, a cytotoxic antibody in people with Solid Tumor Cancer and Solid Tumor Cancer Treatment With Immunotherapy, run by Jun Zhou at 6 sites in China.
Trial summary
This study is to evaluate a novel cytotoxic anti-PD-L1, IUAb190708, for the treatment of tumor Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor Cancer, Solid Tumor Cancer Treatment With Immunotherapy
- What is being tested?
- IUAb190708, a cytotoxic antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesChina
- Study dates
- 18 Jun 2024to 30 Jun 2028
- Phase
- Phase 1
- 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
- Male or female adult, age 18 - 75, understanding and voluntarily signing an informed consent form
- A histologically confirmed diagnosis of Metastatic or locally advanced solid tumors, ineffective management of therapeutic regimen or currently no approved treatment available for the tumor, or unsuitable or refusing to receive standard treatment
- In Phase Ia, for tumors with approved indications of anti PD-1/PD-L1 treatment, unrestricted to PD-L1 expression; for tumors that have not yet been approved for indications, positive expression of PD-L1 required. In Phase Ib, positive expression of PD-L1 is required
- Subjects should provide fresh or archived tissue samples
- Subjects must have at least one measurable lesion per iRECIST
- Life expectancy ≥ 3 months
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- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Adequate organ function, and no blood transfusion, erythropoietin (EPO), and granulocyte colony-stimulating factor at least 14 days before the study drug administration
- All the female of child-bearing age must have a negative pregnancy test (unine or serum) during screening period and agree to use effective medical contraception from written informed consent to at least 6 months after the last administration of the study drug. Male partners also must agree to use effective medical contraception from written informed consent to at least 6 months after the last administration of the study drug.
Who cannot join
- Serious/active infection or infection requiring intravenous antibiotic treatment within 4 weeks prior to the first dose of the study drug
- Receiving nitrosourea and mitomycin C within 6 weeks prior to the first dose of the study drug; receiving oral fluorouracil derivatives or small molecule targeted drugs within 2 weeks prior to the first dose or 5 half-lives of the drug (whichever is longer); receiving endocrine therapy, Immunotherapy, or Traditional Chinese Medicine for anti-tumor indications within 2 weeks prior to the first dose of the study drug; receiving other anti-tumor therapies, such as chemotherapy, radiation, biotherapy, besides as described above treatments, within 4 weeks prior to the first dose of the study drug
- Having other primary active malignant tumors within 5 years prior to the first dose of the study drug
- Having clinically significant cardiovascular diseases,
- Primary tumors of central nervous system or CNS metastatic tumors that have failed local treatment. For asymptomatic or clinically stable symptoms without the need for steroid hormones and other treatments for CNS metastasis lasting ≥ 28 days, CNS tumors under stable condition, including new CNS metastasis without any syndrome, confirmed by imaging during screening period can be enrolled.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
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- History of allogeneic organ transplant.
- Known history of infection with Human Immunodeficiency Virus (HIV) or other acquired or congenital immunodeficiency.
- Patients with serious psychiatric or medical condition that could interfere with medication adherence.
- Receiving systemic corticosteroid therapy (prednisone >10 mg/day or Bioequivalent dose of hydrocortisone) within 2 week prior to the first dose of trial treatment or receiving any other form of systemic immunosuppressive medication, except the condition as described below: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, or short-term (≤7 days) use of glucocorticoids for prophylactic treatment.
- Active or history of autoimmune disease that requires systemic treatment within 2 years prior to enrollment (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). But the subjects with the following diseases are allowed to be enrolled: Type I diabetes with stable condition after using fixed dose insulin; Autoimmune hypothyroidism that only requires hormone replacement therapy.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, interstitial pneumonia or evidence of active pneumonia detected during chest CT scan screening.
- Having experienced immune related adverse events of ≥ 3 grade during receiving any immunotherapy medication in the past.
- Adverse reactions from previous anti-tumor treatments have not yet recovered to ≤1 grade per CTCAE 5.0 (except alopecia and other adverse reactions that the investigator determines that there is no safety risk)
- Underwent major surgery within 4 weeks prior to the first dose of the study drug, or not fully recovered after surgery, or planned surgery within the expected participation time of the subject in the study or within 4 weeks after the last dose of the study drug.
- Treponema pallidum antibody positive; active hepatitis B (HBsAg positive with HBV-DNA>500IU/mL); active hepatitis C (except subjects with HCV antibody positive and HCV-RNA <lower limit of clinical research organization).
- Subjects with history or current evidence of any clinical condition or laboratory abnormality or other reasons are not suitable to participate in this clinical study by the investigator.
- Female who are pregnant or breastfeeding
- Subjects with history of other serious systemic diseases are not suitable to participate in this clinical study by the investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Anyang tumor hospital
Anyang, Henan
Zhenzhen Fu, (+86)0372-2233010, ayhmghw@163.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Min Zhou, (+86)13599436404, fjszlyyjgb@163.com
- Recruiting
Cancer hospital of Shandong First Medical University
Jinan, Shandong
Yue Dong, (+86)0531-67626929, sdtumor_ethics@163.com
- Recruiting
Fudan University Shanghai cancer center
Shanghai
Enying Cao, (+86)15902114065, enyingcao@yeah.net
- Recruiting
Shanghai Pulmonary hospital
Shanghai
Yan Tao, (+86)021-65115006 ext. 1053, shfkgcp@163.com
- Recruiting
Shanghai Xinhua hospital
Shanghai
Wei Shen, （+86）13301788863, Joanshenwei@126.com
About this study
This study is to evaluate a novel cytotoxic anti-PD-L1, IUAb190708, for the treatment of tumor
Read the detailed description
PD-L1 is universally expressed in various types of tumors and an important immune down-regulation factor in tumor microenvironment. Application of PD-L1 to cancer therapy is based on the inhibitory mechanism of the PD-L1/PD-1 pathway on T cell function, and as a result, PD-L1 blocking antibodies are developed, IUAb190708 is a humanized monoclonal immunoglobulin G1 κ subclass (IgG1) antibody that specifically recognizes PD-L1 (also known as CD274). Different from known PD-L1 blocking antibodies, i.e., they block the interaction of PD-L1 with PD-1 that recovers T cell function leading to indirect killing of tumor. Whereas IUAb190708 is to induce antibody dependent cell-mediated cytotoxicity (ADCC), i.e., it activates NK cells leading to direct killing of tumor.
IUAB190708 can be used as a monotherapy or in combination with other immunotherapies, chemotherapy, and radiation to improve the efficacy of tumor treatment.
In the open-label Phase I study, safety, tolerance, pharmacokinetics and activity of IUAb190708 in subjects with advanced or recurrent solid tumors will be evaluated, and MTD, DLT, and RP2D of IUAb190708 will be determined, and eligible subjects will be administered with IUAb190708 at different doses via intravenous infusion.
- Being tested
- IUAb190708, a cytotoxic antibody
- Keywords
- cytotoxic antibody, PD-L1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUAb190708, a cytotoxic antibodyDrug
a novel cytotoxic anti-PD-L1 antibody
| Study group | Role | What they receive |
|---|---|---|
| IUAb190708 treatment | Experimental | After a screening phase of 28 days, eligible subjects will be enrolled into IUAb190708 group.
* Dose escalation: 0.2, 1, 3, 10, 15 mg/kg
* Dose expansion: 10 mg/kg or 15 mg/kg
* IUAb190708 is administered intravenously, q2w Receives: Drug: IUAb190708, a cytotoxic antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (ORR), defined as the number of subjects with complete response (CR) or partial response (PR) divided by the number of subjects in the population of interest.
Measured: 2 years
Secondary outcomes (4)
DOR
Duration of Objective Response (DOR), defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first.
Measured: 2 years
PFS
Progressive free survival (PFS), defined as the time between date of first dose of study therapy and date of progression or death, whichever occurs first.
Measured: 2 years
OS
Overall survival (OS), defined as the time between the date of first dose of study therapy and the date of death.
Measured: 2 years
Incidence and severity of adverse events (AEs)
Severity is determined based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE Version 5.0)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start18 Jun 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Zhou
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University, Hunan Cancer Hospital, Fujian Cancer Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shandong Cancer Hospital and Institute, Anyang Tumor Hospital
- Responsible party
- Sponsor-investigator, Jun Zhou, ImmunoUrchin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584954
- Sponsor's protocol ID
- IUAb220910-01
- Other IDs
- CTR20241263
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-labeled, Dose-escalation, Dose-expansion Study Evaluating the Safety, Tolerance, Pharmacokinetics, and Activity of IUAb190708 in Patients With Advanced or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT07584954
- Acronym / sponsor ID
- IUAb220910-01
- Keywords
- cytotoxic antibody, PD-L1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jun ZhouIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University, Hunan Cancer Hospital, Fujian Cancer Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shandong Cancer Hospital and Institute, Anyang Tumor Hospital
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 May 2026 (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 to evaluate a novel cytotoxic anti-PD-L1, IUAb190708, for the treatment of tumor
Detailed description
PD-L1 is universally expressed in various types of tumors and an important immune down-regulation factor in tumor microenvironment. Application of PD-L1 to cancer therapy is based on the inhibitory mechanism of the PD-L1/PD-1 pathway on T cell function, and as a result, PD-L1 blocking antibodies are developed, IUAb190708 is a humanized monoclonal immunoglobulin G1 κ subclass (IgG1) antibody that specifically recognizes PD-L1 (also known as CD274). Different from known PD-L1 blocking antibodies, i.e., they block the interaction of PD-L1 with PD-1 that recovers T cell function leading to indirect killing of tumor. Whereas IUAb190708 is to induce antibody dependent cell-mediated cytotoxicity (ADCC), i.e., it activates NK cells leading to direct killing of tumor.
IUAB190708 can be used as a monotherapy or in combination with other immunotherapies, chemotherapy, and radiation to improve the efficacy of tumor treatment.
In the open-label Phase I study, safety, tolerance, pharmacokinetics and activity of IUAb190708 in subjects with advanced or recurrent solid tumors will be evaluated, and MTD, DLT, and RP2D of IUAb190708 will be determined, and eligible subjects will be administered with IUAb190708 at different doses via intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IUAb190708 treatment | Experimental | Drug: IUAb190708, a cytotoxic antibodyAfter a screening phase of 28 days, eligible subjects will be enrolled into IUAb190708 group. * Dose escalation: 0.2, 1, 3, 10, 15 mg/kg * Dose expansion: 10 mg/kg or 15 mg/kg * IUAb190708 is administered intravenously, q2w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female adult, age 18 - 75, understanding and voluntarily signing an informed consent form
- A histologically confirmed diagnosis of Metastatic or locally advanced solid tumors, ineffective management of therapeutic regimen or currently no approved treatment available for the tumor, or unsuitable or refusing to receive standard treatment
- In Phase Ia, for tumors with approved indications of anti PD-1/PD-L1 treatment, unrestricted to PD-L1 expression; for tumors that have not yet been approved for indications, positive expression of PD-L1 required. In Phase Ib, positive expression of PD-L1 is required
- Subjects should provide fresh or archived tissue samples
- Subjects must have at least one measurable lesion per iRECIST
Key exclusion criteria (19 listed)
- Serious/active infection or infection requiring intravenous antibiotic treatment within 4 weeks prior to the first dose of the study drug
- Receiving nitrosourea and mitomycin C within 6 weeks prior to the first dose of the study drug; receiving oral fluorouracil derivatives or small molecule targeted drugs within 2 weeks prior to the first dose or 5 half-lives of the drug (whichever is longer); receiving endocrine therapy, Immunotherapy, or Traditional Chinese Medicine for anti-tumor indications within 2 weeks prior to the first dose of the study drug; receiving other anti-tumor therapies, such as chemotherapy, radiation, biotherapy, besides as described above treatments, within 4 weeks prior to the first dose of the study drug
- Having other primary active malignant tumors within 5 years prior to the first dose of the study drug
- Having clinically significant cardiovascular diseases,
- Primary tumors of central nervous system or CNS metastatic tumors that have failed local treatment. For asymptomatic or clinically stable symptoms without the need for steroid hormones and other treatments for CNS metastasis lasting ≥ 28 days, CNS tumors under stable condition, including new CNS metastasis without any syndrome, confirmed by imaging during screening period can be enrolled.
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 |
|---|---|---|
| IUAb190708, a cytotoxic antibodya novel cytotoxic anti-PD-L1 antibody | Drug | IUAb190708 treatment |
Primary outcome
ORR
Time frame: 2 years
Objective response rate (ORR), defined as the number of subjects with complete response (CR) or partial response (PR) divided by the number of subjects in the population of interest.
4 secondary outcomes
DOR
Time frame: 2 years
PFS
Time frame: 2 years
OS
Time frame: 2 years
Incidence and severity of adverse events (AEs)
Time frame: 2 years
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 13 May 2026.
- Individual participant dataSharing planned: Yes
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IUAb190708, a cytotoxic antibody in people with Solid Tumor Cancer and Solid Tumor Cancer Treatment With Immunotherapy, run by Jun Zhou at 6 sites 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 19 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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 Jun Zhou, Ph.D ((+86)18018182095, jun_zhou@immunourchin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 2 years). 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 13 May 2026.