Clinical Trials List
Protocol NumberOBI-902-001
Active
2025-08-01 - 2029-02-08
Phase I
Recruiting3
A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-902 in Participants with Advanced Solid Tumors
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Trial Applicant
OBI PHARMA, INC.
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Sponsor
OBI Pharma, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 王秀慈 Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蕭炳坤 Division of General Surgery
- Tzeon-jye Chiou Division of Hematology & Oncology
- Chia-Lun Chang Division of Hematology & Oncology
- Wei-Wen Chang Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wei-Hong Cheng
Co-Principal Investigator
- Yao-Yu Hsieh
- 莊博雅
- TSU-YI CHAO
- 蔡承志 Division of Hematology & Oncology
- HUI-WEN LIU
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
To determine the safety and tolerability of OBI-902 when administered IV to participants with advanced solid tumors
•
To determine the MTD and optimal RP2D of OBI-902 using randomized assignment to 2 dose level cohorts and assessment of activity, safety, and tolerability for each cohort
•
To evaluate the preliminary clinical activity profile of OBI-902 (ORR, CBR, and DCR)
Test Drug
injective
Active Ingredient
OBI-902 (a humanized TROP2 monoclonal antibody conjugate)
Dosage Form
270
Dosage
50mg/5ml
Endpoints
Part A – Phase 1 Dose Escalation:
•
AEs and SAEs and laboratory abnormalities as graded by the NCI CTCAE version 5.0
•
DLTs
•
MTD
Part B – Phase 2 Cohort Expansion:
•
Percentage of participants with ORR, CBR, and DCR according to RECIST version 1.1 for each cohort
•
AEs/SAEs and laboratory abnormalities as graded by NCI CTCAE version 5.0
•
AEs and SAEs and laboratory abnormalities as graded by the NCI CTCAE version 5.0
•
DLTs
•
MTD
Part B – Phase 2 Cohort Expansion:
•
Percentage of participants with ORR, CBR, and DCR according to RECIST version 1.1 for each cohort
•
AEs/SAEs and laboratory abnormalities as graded by NCI CTCAE version 5.0
Inclution Criteria
Participants must meet all the following criteria to be included in the study (for both Parts A and B unless specified otherwise):
1.
Male or female participants, 18 years of age or older at the time of consent
2.
Provide written informed consent prior to performing any study-related procedure
3.
Histologically or cytologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies
4.
Participants must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or participants have declined to receive standard-of-care therapy. In the latter case, the source documentation must state the effective therapies the participant is declining.
5.
Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
6.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7.
Adequate organ function defined as:
a.
Hepatic:
i.
Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
ii.
Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
iii.
Serum bilirubin 1.5 × ULN (unless due to Gilbert’s syndrome (typically elevated total bilirubin of 1–5 mg/dL with a normal direct bilirubin) or hemolysis)
b.
Creatinine clearance >60 mL/minute using Modification of Diet in Renal Disease equation (Beumer et al., 2015)
c.
Hematologic:
i.
ANC ≥1,500/μL (>1,200/μL in Duffy antigen-null participants)
ii.
Platelets ≥100,000/μL
iii.
Hemoglobin ≥8 g/dL
8.
Participants must be willing and able to comply with all protocol-required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline. Each biopsy slide shall include ≥ 100 tumor cells.
9.
Females of childbearing potential must have negative serum pregnancy test prior to starting study therapy and agree to use a reliable form of contraceptive during the study treatment period and for at least 7 months following the last dose of study drug.
1.
Male or female participants, 18 years of age or older at the time of consent
2.
Provide written informed consent prior to performing any study-related procedure
3.
Histologically or cytologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies
4.
Participants must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or participants have declined to receive standard-of-care therapy. In the latter case, the source documentation must state the effective therapies the participant is declining.
5.
Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
6.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7.
Adequate organ function defined as:
a.
Hepatic:
i.
Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
ii.
Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
iii.
Serum bilirubin 1.5 × ULN (unless due to Gilbert’s syndrome (typically elevated total bilirubin of 1–5 mg/dL with a normal direct bilirubin) or hemolysis)
b.
Creatinine clearance >60 mL/minute using Modification of Diet in Renal Disease equation (Beumer et al., 2015)
c.
Hematologic:
i.
ANC ≥1,500/μL (>1,200/μL in Duffy antigen-null participants)
ii.
Platelets ≥100,000/μL
iii.
Hemoglobin ≥8 g/dL
8.
Participants must be willing and able to comply with all protocol-required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline. Each biopsy slide shall include ≥ 100 tumor cells.
9.
Females of childbearing potential must have negative serum pregnancy test prior to starting study therapy and agree to use a reliable form of contraceptive during the study treatment period and for at least 7 months following the last dose of study drug.
Exclusion Criteria
1.
Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of OBI-902.
2.
Participants that have undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-902.
3.
Sensory or motor neuropathy of Grade 2 or greater.
4.
Participants with a history of solid organ transplant. Corneal transplant without immunosuppressive therapy is allowed.
5.
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using NCI CTCAE version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
6.
Receipt of any prior therapy targeting TROP2. (Phase 2 only)
7.
Corrected QT interval (QTcF) prolongation to >470 msec based on the average of the screening 12-lead ECGs
8.
Known hypersensitivity to OBI-902 or its excipients.
9.
Participants with known untreated central nervous system (CNS) metastases. Participants with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period.
10.
Participants with significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina).
11.
Any medical comorbidity that is life-threatening or, in the opinion of the Investigator, renders the participant unsuitable for participation in a clinical trial due to possible noncompliance, would place the participant at an unacceptable risk (e.g. ILD) and/or potential to affect interpretation of results of the study.
12.
Is receiving any concurrent prohibited medications as listed in Section 6.8.1 and Section 16.
Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of OBI-902.
2.
Participants that have undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-902.
3.
Sensory or motor neuropathy of Grade 2 or greater.
4.
Participants with a history of solid organ transplant. Corneal transplant without immunosuppressive therapy is allowed.
5.
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using NCI CTCAE version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
6.
Receipt of any prior therapy targeting TROP2. (Phase 2 only)
7.
Corrected QT interval (QTcF) prolongation to >470 msec based on the average of the screening 12-lead ECGs
8.
Known hypersensitivity to OBI-902 or its excipients.
9.
Participants with known untreated central nervous system (CNS) metastases. Participants with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period.
10.
Participants with significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina).
11.
Any medical comorbidity that is life-threatening or, in the opinion of the Investigator, renders the participant unsuitable for participation in a clinical trial due to possible noncompliance, would place the participant at an unacceptable risk (e.g. ILD) and/or potential to affect interpretation of results of the study.
12.
Is receiving any concurrent prohibited medications as listed in Section 6.8.1 and Section 16.
The Estimated Number of Participants
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Taiwan
35 participants
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Global
111 participants
