MTDPhase 1/2NCT06292208
A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors
A Phase 1/2 study testing IBD0333 in people with MTD, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 1 site in China.
Trial summary
Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- MTD
- What is being tested?
- IBD0333
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2024to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible for participation in this trial, the patient must:
- Male or female, 18 to 80 years old.
- Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumor or non-Hodgkin lymphoma who have failed or have no standard therapy, or for whom the standard therapy is intolerant.
- There is at least one assessable tumor lesion in the dose escalation phase and at least one measurable lesion in the dose expansion phase according to RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas) (tumor lesions located in areas of prior radiotherapy or other localized regional treatment areas are generally not considered as measurable lesions unless the lesion shows definite progression or persists after 3 months of radiotherapy).
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Have a life expectancy of at least 3 months.
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- Have adequate organ function as indicated by the following laboratory values.
- Hematological (no transfusion or hematopoietic stimulating factor therapy within 14 days): absolute neutrophil count (ANC)≥1.5×109/L, platelet count (PLT)≥ 90 ×109/L, hemoglobin (HGB)≥90 g/L;
- Hepatic: total bilirubin (TBIL)≤1.5×upper limit of normal (ULN), except for Gilbert syndrome; alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤3.0×ULN, or ALT and AST ≤ 5.0×ULN in patients with liver metastases or liver cancer;
- Renal: creatinine clearance (Ccr)≥50mL/min (calculated according to the Cockcroft-Gault Method:);
- Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Eligible patients (male and female) of childbearing potential must agree to use a reliable contraception measure (hormonal or barrier contraception or abstinence) with their partner for the duration of the trial and for at least 120 days after the discontinuation of investigational product. Female patients of childbearing potential must have a negative serum pregnancy test at within 7 days of first dose of investigational product.
- According to the investigator's assessment, the patient could benefit from IBD0333.
- Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.
Who cannot join
- Known hypersensitivity reaction (NCI-CTCAE 5.0 ≥ grade 3) recombinant proteins or any excipient contained in the drug or vehicle formulation for IBD0333.
- History of 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune costimulatory molecule agonist.
- History of anti-cancer therapies prior to the initiation of investigational product (chemotherapy within 3 weeks; radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy within 4 weeks) and the following are except:
- Nitrosourea or mitomycin C within 6 weeks prior to the initiation of investigational product;
- Oral fluorouracil and small molecule-targeted drugs within 2 weeks prior to the initiation of investigational product;
- Chinese patent drugs within 2 weeks prior to the initiation of investigational product.
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- History of investigational anti-cancer drug within 4 weeks prior to the initiation of investigational product.
- History of major surgery (except for puncture biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product, or require the selective surgery during the trial.
- History of systemic corticosteroids (prednisone >10 mg/day or equivalent) or immunosuppressive medication <14 days prior to the initiation of investigational product. Steroids for topical, ocular, intra-articular, intranasal and inhaled and short-term prophylactic treatment (e.g., to prevent contrast allergy) were allowed.
- Treatment with immunomodulatory agents within 14 days prior to the initiation of investigational product, including but not limited to thymidine, interleukin-2, interferon, etc.
- Vaccination with live attenuated vaccine within 4 weeks prior to the initiation of investigational product.
- History of allogeneic hematopoietic stem cell or organ transplantation.
- The adverse effects related to prior anticancer treatment (except alopecia, peripheral neurotoxicity with grade 2, and stable hypothyroidism after hormone replacement therapy or the other toxicities judged by the investigator without safety risk) that have not resolved to ≤ Grade 1 according to common terminology criteria for adverse events (NCI-CTCAE 5.0) or relevant provisions of the inclusion criteria prior to initiation of investigational product.
- Parenchymal brain metastases or meningeal metastases unless previously received therapies and have no evidence of progression on magnetic resonance imaging (MRI) or computed tomography (CT) for at least 8 weeks after the treatment and for 4 weeks prior to the initiation of investigational product.
- Evidence of active infection requiring intravenous systemic therapy.
- History of immunodeficiency, including the positive for human immunodeficiency virus (HIV) antibodies.
- Active hepatitis B infection (HBsAg positive and HBV-DNA > 500 IU/mL or lower limit of detection [only if lower limit is above 500 IU/mL]). Active hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
- Has interstitial lung disease (except for the radiographic pulmonary fibrosis without hormone therapy).
- History of serious cardiovascular disease, including but not limited to:
- Have severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III-degree atrioventricular block, etc.;
- The mean QT interval corrected for heart rate by Fridericia's formula (QTcF) >470msec.
- History of acute coronary syndromes, congestive heart failure, aortic dissection, stroke or other cardiovascular or cerebrovascular ≥ grade 3 within the 6 months prior to initiation of investigational product.
- Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system or left ventricular ejection fraction (LVEF) < 50%, or structural heart disease with high risk judged by investigators;
- Uncontrollable hypertension.
- Previous or current autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for the stable autoimmune thyroid disease, type I diabetes, vitiligo, cured atopic dermatitis in children, and psoriasis (within the past 2 years and without systemic therapy).
- History of ≥Grade 3 Immune-Related Adverse Events (irAE) or ≥Grade 2 immune-associated myocarditis (experienced immune-associated thyroid toxicity ≥grade 3 could be enrolled).
- History of malignancy or current other malignant tumors (other than in non-melanoma skin cancer, localized prostate cancer, carcinoma in situ [situ cervical cancer] treated with curative intent and without evidence of disease for 2 years or longer).
- Has uncontrollable third interstitial fluid that are unsuitable for enrollment (judged by the investigator).
- Has alcohol or drug dependence.
- Has a psychiatric disorder or poor compliance.
- Pregnant or breastfeeding. Have serious systemic disease or are unsuitable for participation in the study.
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
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Jinming Yu, M.D., 13806406293, sdyujinming@126.com
About this study
Official title: Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) and Preliminary Efficacy of IBD0333 in Patients With Locally Advanced/Metastatic Solid Tumor or Non-Hodgkin Lymphoma
Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT).
Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D).
Read more
Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor.
Secondary objectives Dose escalation phase \& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma.
Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333.
- Conditions
- MTD
- Being tested
- IBD0333
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBD0333Biological
This is a phase I/II, open, non-randomized, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma in dose-escalation, dose-expansion, and clinical exploration phases.
| Study group | Role | What they receive |
|---|---|---|
| IBD0333 | Experimental | Not described Receives: Biological: IBD0333 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Maximum tolerated dose
Measured: through study completion, an average of 1 year
DRDE
Extended recommended dose
Measured: through study completion, an average of 1 year
Dose limiting toxicity (DLT)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Measured: 28 days after first dose(dose-escalation phase)
RP2D
Recommended Phase 2 dose
Measured: through study completion, an average of 1 year
ORR
Objective response rate
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
pharmacokinetic parameters
AUC0-t
Measured: through study completion, an average of 1 year
pharmacokinetic parameters
Cmax
Measured: through study completion, an average of 1 year
pharmacokinetic parameters
Tmax
Measured: through study completion, an average of 1 year
pharmacokinetic parameters
t1/2
Measured: through study completion, an average of 1 year
ADA
Anti-drug antibody
Measured: through study completion, an average of 1 year
ORR
Objective response rate
Measured: through study completion, an average of 1 year
DCR
Disease control rate
Measured: through study completion, an average of 1 year
DoR
Duration of relief
Measured: through study completion, an average of 1 year
PFS
Progression-free survival
Measured: through study completion, an average of 1 year
Frequency of adverse events (AEs) and SAEs
To investigate the safety characteristics.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start9 Mar 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MTDStudies of the same condition, open and under way.
- More trials run by SUNHO（China）BioPharmaceutical CO., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292208
- Sponsor's protocol ID
- IBD0333-101
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) and Preliminary Efficacy of IBD0333 in Patients With Locally Advanced/Metastatic Solid Tumor or Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06292208
- Acronym / sponsor ID
- IBD0333-101
- Conditions
- MTD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Mar 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.
Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT).
Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D).
Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor.
Secondary objectives Dose escalation phase \& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma.
Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD0333 | Experimental | Biological: IBD0333 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, 18 to 80 years old.
- Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumor or non-Hodgkin lymphoma who have failed or have no standard therapy, or for whom the standard therapy is intolerant.
- There is at least one assessable tumor lesion in the dose escalation phase and at least one measurable lesion in the dose expansion phase according to RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas) (tumor lesions located in areas of prior radiotherapy or other localized regional treatment areas are generally not considered as measurable lesions unless the lesion shows definite progression or persists after 3 months of radiotherapy).
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Have a life expectancy of at least 3 months.
Key exclusion criteria (31 listed)
- Known hypersensitivity reaction (NCI-CTCAE 5.0 ≥ grade 3) recombinant proteins or any excipient contained in the drug or vehicle formulation for IBD0333.
- History of 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune costimulatory molecule agonist.
- History of anti-cancer therapies prior to the initiation of investigational product (chemotherapy within 3 weeks; radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy within 4 weeks) and the following are except:
- History of investigational anti-cancer drug within 4 weeks prior to the initiation of investigational product.
- History of major surgery (except for puncture biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product, or require the selective surgery during the trial.
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 |
|---|---|---|
| IBD0333This is a phase I/II, open, non-randomized, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma in dose-escalation, dose-expansion, and clinical exploration phases. | Biological | IBD0333 |
Primary outcome
MTD
Time frame: through study completion, an average of 1 year
Maximum tolerated dose
DRDE
Time frame: through study completion, an average of 1 year
Extended recommended dose
Dose limiting toxicity (DLT)
Time frame: 28 days after first dose(dose-escalation phase)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
RP2D
Time frame: through study completion, an average of 1 year
Recommended Phase 2 dose
ORR
Time frame: through study completion, an average of 1 year
Objective response rate
10 secondary outcomes
pharmacokinetic parameters
Time frame: through study completion, an average of 1 year
pharmacokinetic parameters
Time frame: through study completion, an average of 1 year
pharmacokinetic parameters
Time frame: through study completion, an average of 1 year
pharmacokinetic parameters
Time frame: through study completion, an average of 1 year
ADA
Time frame: through study completion, an average of 1 year
ORR
Time frame: through study completion, an average of 1 year
DCR
Time frame: through study completion, an average of 1 year
DoR
Time frame: through study completion, an average of 1 year
PFS
Time frame: through study completion, an average of 1 year
Frequency of adverse events (AEs) and SAEs
Time frame: through study completion, an average of 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 17 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IBD0333 in people with MTD, run by SUNHO（China）BioPharmaceutical 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 14 inclusion and 31 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 17 Jan 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Na Li (18229969355, lina@sunho-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: through study completion, an average of 1 year). The study lists 5 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 17 Jan 2025.