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Trial Title:
A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors
NCT ID:
NCT06292208
Condition:
MTD
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
IBD0333
Description:
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.
Arm group label:
IBD0333
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).
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria
In order to be eligible for participation in this trial, the patient must:
1. Male or female, 18 to 80 years old.
2. 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.
3. 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).
4. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Status.
5. Have a life expectancy of at least 3 months.
6. Have adequate organ function as indicated by the following laboratory values.
1. 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;
2. 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;
3. Renal: creatinine clearance (Ccr)≥50mL/min (calculated according to the
Cockcroft-Gault Method:);
4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, activated partial
thromboplastin time (APTT) ≤1.5×ULN.
7. 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.
8. According to the investigator's assessment, the patient could benefit from IBD0333.
9. Patients must have signed an informed consent document stating that they understand
the investigational nature of the proposed treatment.
Exclusion Criteria
1. Known hypersensitivity reaction (NCI-CTCAE 5.0 ≥ grade 3) recombinant proteins or
any excipient contained in the drug or vehicle formulation for IBD0333.
2. History of 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune
costimulatory molecule agonist.
3. 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:
1. Nitrosourea or mitomycin C within 6 weeks prior to the initiation of
investigational product;
2. Oral fluorouracil and small molecule-targeted drugs within 2 weeks prior to the
initiation of investigational product;
3. Chinese patent drugs within 2 weeks prior to the initiation of investigational
product.
4. History of investigational anti-cancer drug within 4 weeks prior to the initiation
of investigational product.
5. 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.
6. 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.
7. Treatment with immunomodulatory agents within 14 days prior to the initiation of
investigational product, including but not limited to thymidine, interleukin-2,
interferon, etc.
8. Vaccination with live attenuated vaccine within 4 weeks prior to the initiation of
investigational product.
9. History of allogeneic hematopoietic stem cell or organ transplantation.
10. 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.
11. 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.
12. Evidence of active infection requiring intravenous systemic therapy.
13. History of immunodeficiency, including the positive for human immunodeficiency virus
(HIV) antibodies.
14. 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.
15. Has interstitial lung disease (except for the radiographic pulmonary fibrosis
without hormone therapy).
16. History of serious cardiovascular disease, including but not limited to:
1. Have severe cardiac rhythm or conduction abnormalities, such as ventricular
arrhythmias requiring clinical intervention, II-III-degree atrioventricular
block, etc.;
2. The mean QT interval corrected for heart rate by Fridericia's formula (QTcF)
>470msec.
3. 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.
4. 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;
5. Uncontrollable hypertension.
17. 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).
18. 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).
19. 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).
20. Has uncontrollable third interstitial fluid that are unsuitable for enrollment
(judged by the investigator).
21. Has alcohol or drug dependence.
22. Has a psychiatric disorder or poor compliance.
23. Pregnant or breastfeeding. Have serious systemic disease or are unsuitable for
participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
March 2, 2024
Completion date:
December 31, 2030
Lead sponsor:
Agency:
SUNHO(China)BioPharmaceutical CO., Ltd.
Agency class:
Industry
Source:
SUNHO(China)BioPharmaceutical CO., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06292208