Clinical Trials List
Protocol NumberOBI-3424-001
NCT Number(ClinicalTrials.gov Identfier)NCT03592264
Completed
2023-03-01 - 2024-03-29
Phase I/II
Not yet recruiting1
Recruiting3
A Phase I/II Study of OBI-3424 in Subjects With Advanced Solid Tumors
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Trial Applicant
OBI PHARMA, INC.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Che-Hung Lin Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
- 王秀慈 Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 曾振輝 Division of General Surgery
- 黃文冠 Division of General Surgery
- Jen-Shi Chen Division of General Surgery
- 黃培青 Division of General Surgery
- 吳教恩 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Ping Hung Division of Hematology & Oncology
- Ta-Chung Chao Division of Hematology & Oncology
- Chun-Yu Liu Division of Hematology & Oncology
- Mu-Hsin Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 顏志傑 Division of Hematology & Oncology
- Chien-Jui Huang Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Solid Tumor
Objectives
main target:
Extension period:
‧ To assess the safety and tolerability of OBI-3424 when administered as a single agent by intravenous injection (IV).
‧ The activity of OBI-3424 was initially evaluated based on its objective response rate (ORR) in patients whose tumors had moderate to high-grade AKR1C3 expression. The trial included patients with pancreatic cancer (cohort A) and a basket cohort of solid tumors with other histological subtypes (cohort B).
Secondary goals:
‧ Confirm duration of response (DOR) and progression-free survival (PFS).
‧ Explore the association between tumor AKR1C3 expression confirmed by immunohistochemistry (IHC) and clinical activity.
‧ Confirm the effect of OBI3424 on immune cell populations related to tumor immune response through lymphocyte immunophenotyping (only during dose escalation).
‧ Investigate the pharmacokinetics of OBI3424 and OBI-2660 in the target population through population analysis, including the impact of covariates, and also provide post-hoc estimates of exposure.
Exploratory goals:
Determine possible baseline covariates associated with predictive biomarkers of AKR1C3 expression or OBI-3424 activity.
Test Drug
OBI-3424
Active Ingredient
OBI-3424
Dosage Form
IV infusion
Dosage
10 mg/mL
Endpoints
Zhǔyào liáoxiào zhǐbiāo: Ānquán xìng: Bùliáng shìjiàn (AE), bāohán yánzhòng chéngdù hé xiāngguān xìng xīndiàntú (ECG), shíyàn shì cānshù, shēngmìng zhǐxiàng hé tǐzhòng jìliàng xiànzhì xìng dúxìng (DLT) OBI-3424 zài zuòwéi dānyī yàojì shí de zuìdà nài shòu jìliàng (MTD) hé dì èr qí shìyàn jiànyì jìliàng (RP2D) yàowù dònglì xué: Yàowù dònglì xué (PK) de biāozhǔn cānshù liáoxiào: Kuòzhǎn qí zhāomù shòu shì zhě de kèguān fǎnyìng lǜ (ORR)
顯示更多
164 / 5,000
Main efficacy indicators:
safety:
Adverse events (AEs), including severity and relevance
Electrocardiogram (ECG), laboratory parameters, vital signs, and weight
Dose-limiting toxicity (DLT)
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-3424 as a single agent
Pharmacokinetics:
Standard Parameters for Pharmacokinetics (PK)
Efficacy:
Objective response rate (ORR) of subjects recruited during the extension phase
顯示更多
164 / 5,000
Main efficacy indicators:
safety:
Adverse events (AEs), including severity and relevance
Electrocardiogram (ECG), laboratory parameters, vital signs, and weight
Dose-limiting toxicity (DLT)
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-3424 as a single agent
Pharmacokinetics:
Standard Parameters for Pharmacokinetics (PK)
Efficacy:
Objective response rate (ORR) of subjects recruited during the extension phase
Inclution Criteria
Inclusion Criteria (all subjects):
At least 18 years of age
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
Recovered from toxicities of prior therapy to Grade 0 or 1
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Acceptable liver function:
Bilirubin ≤1.5 × institutional ULN
AST and ALT ≤3.0 × ULN, or ≤5.0 × ULN for subjects with liver involvement
Acceptable renal function:
a. Creatinine clearance >30 mL/min according to the Cockcroft-Gault formula
Acceptable hematologic status (without hematologic support, other than red blood cell transfusion):
ANC ≥1500 cells/μL
Platelet count ≥100,000/μL
Hemoglobin ≥9.0 g/dL (prior packed red blood cell transfusion or erythropoietin support is allowed).
Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation.
Dose Escalation Phase Subjects Only (Inclusion Criteria):
Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Tumor progression after most recent therapy
Expansion Phase Subjects Only (Inclusion Criteria):
Available tumor tissue, either archival or fresh (fresh preferred).
For treatment, an AKR1C3 IHC H-score of ≥ 100 using a validated IHC assay in one of the following tumor types to be enrolled in the respective cohort:
Cohort A: Pancreatic Adenocarcinoma
Cohort B: Basket (any solid tumor type other than pancreatic adenocarcinoma)
At least 18 years of age
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
Recovered from toxicities of prior therapy to Grade 0 or 1
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Acceptable liver function:
Bilirubin ≤1.5 × institutional ULN
AST and ALT ≤3.0 × ULN, or ≤5.0 × ULN for subjects with liver involvement
Acceptable renal function:
a. Creatinine clearance >30 mL/min according to the Cockcroft-Gault formula
Acceptable hematologic status (without hematologic support, other than red blood cell transfusion):
ANC ≥1500 cells/μL
Platelet count ≥100,000/μL
Hemoglobin ≥9.0 g/dL (prior packed red blood cell transfusion or erythropoietin support is allowed).
Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation.
Dose Escalation Phase Subjects Only (Inclusion Criteria):
Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Tumor progression after most recent therapy
Expansion Phase Subjects Only (Inclusion Criteria):
Available tumor tissue, either archival or fresh (fresh preferred).
For treatment, an AKR1C3 IHC H-score of ≥ 100 using a validated IHC assay in one of the following tumor types to be enrolled in the respective cohort:
Cohort A: Pancreatic Adenocarcinoma
Cohort B: Basket (any solid tumor type other than pancreatic adenocarcinoma)
Exclusion Criteria
Exclusion Criteria:
Prior radiotherapy to more than 25% of the bone marrow
Symptomatic brain metastases, unless previously treated and well controlled for at least 4 weeks after central nervous system (CNS)-directed treatment as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the Screening Period. Patients with known leptomeningeal disease are excluded.
Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the current study
Patients with hepatocellular carcinoma (applies to Expansion Phase only)
Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 3 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C)
Concomitant use of strong CYP3A4 inhibitors/inducers
Concomitant use of naproxen within a 48-hour window before and after OBI-3424 dosing
Females who are pregnant or breast-feeding
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Unwillingness or inability to comply with the study protocol for any reason
Prior radiotherapy to more than 25% of the bone marrow
Symptomatic brain metastases, unless previously treated and well controlled for at least 4 weeks after central nervous system (CNS)-directed treatment as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the Screening Period. Patients with known leptomeningeal disease are excluded.
Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the current study
Patients with hepatocellular carcinoma (applies to Expansion Phase only)
Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 3 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C)
Concomitant use of strong CYP3A4 inhibitors/inducers
Concomitant use of naproxen within a 48-hour window before and after OBI-3424 dosing
Females who are pregnant or breast-feeding
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Unwillingness or inability to comply with the study protocol for any reason
The Estimated Number of Participants
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Taiwan
32 participants
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Global
101 participants
