Advanced Solid TumorPhase 1/2NCT07124117
A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors
A Phase 1/2 study testing OBI-902 in people with Advanced Solid Tumor, run by OBI Pharma, Inc at 6 sites in 2 countries.
Trial summary
This is a 3-part study. Phase 1a (dose escalation) is designed to assess the safety and tolerability and to determine the maximum tolerated dose (MTD) and putative recommended phase 2 dose (RP2D) of study drug as monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- OBI-902
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 4 Aug 2025to 8 Feb 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants, 18 years of age or older at the time of consent
- Provide written informed consent prior to performing any study-related procedure
- Histologically or cytologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies
- Participants must have been treated with established standard-of-care therapy, andphysicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy. In the latter case, the source documentation must state the effective therapies the participant is declining.
- Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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- Adequate organ function defined as:
- Hepatic:
- Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
- Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
- 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)
- Creatinine clearance >60 mL/minute using Modification of Diet in Renal Disease equation
- Hematologic:
- ANC ≥1,500/µL (>1,200/µL in Duffy antigen-null participants)
- Platelets ≥100,000/µL
- Hemoglobin ≥8 g/dL
- Participants must be willing and able to comply with all protocol-required assessments, visits, and procedures, including evaluable pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
- 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.
- Participants not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in the trial. Postmenopausal is defined as 12 months with no menses without an alternative medical cause. Male participants must agree to use an adequate method of contraception during the study treatment period and for at least 4 months following the last dose of study drug.
- Participants with human immunodeficiency virus (HIV) infection or with documented history of HIV infection are eligible if CD4+ T-cell counts are ≥350 cells/μL and have an HIV viral load less than 200 copies/mL prior to enrollment. Participants on ART should be on an established dose for at least 4 weeks under stable condition.
- Participants with serological evidence of chronic HBV infection or with documented history of HBV infection are eligible if they have an HBV viral load below the limit of quantification with or without concurrent viral suppressive therapy.
- Participants with a history of HCV infection can be under curative antiviral treatment and have a viral load below the limit of quantification.
- Participants in Phase 1b (Cohort Expansion) - must have one of the following tumor types to be enrolled in the respective cohort:
- Cohort 1: BTC (intra- and extrahepatic CCA, carcinoma of ampulla of Vater, and gallbladder disease)
- Cohort 2: Gastric and GEJ cancer
- Cohort 3: PROC
Who cannot join
- 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.
- 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.
- Sensory or motor neuropathy of Grade 2 or greater.
- Participants with a history of solid organ transplants. Corneal transplant without immunosuppressive therapy is allowed.
- 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.
- Receipt of any prior therapy targeting TROP2. (Phase 2 only)
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- Corrected QT interval (QTcF) prolongation to >470 msec based on the average of the screening 12-lead ECGs
- Known hypersensitivity to OBI-902 or its excipients.
- 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.
- Participants with significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina).
- 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 and/or potential to affect interpretation of results of the study.
- Participants who are pregnant or breastfeeding.
- Is receiving any concurrent prohibited medications as listed in OBI-902-001 clinical protocol.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
OBI Investigator Site
- Recruiting
Scripps Green Hospital
La Jolla, California, 92037
OBI Investigator Site
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
OBI Investigator Site
Taiwan3 sites, 2 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404327
OBI Investigator Site
- Recruiting
Wan Fan Hospital
Taipei, Wenshan, 116
OBI Investigator Site
- Active, not recruiting
Shuang Ho Hospital
Taipei, Zhonghe, 23561
About this study
Official title: 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
This is a 3-part study. Phase 1a (dose escalation) is designed to assess the safety and tolerability and to determine the maximum tolerated dose (MTD) and putative recommended phase 2 dose (RP2D) of study drug as monotherapy. Phase 1b (Cohort Expansion) is intended to further characterize the safety and preliminary antitumor activity of the putative RP2D of OBI-902 in selected tumor types. Phase 2 (Randomized Dose Optimization Cohorts) is intended to determine the optimal RP2D of OBI-902 in selected tumor types, before advancing to larger Phase 3 trials.
- Conditions
- Advanced Solid Tumor
- Being tested
- OBI-902
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBI-902Drug
OBI-902 is an antibody-drug conjugate study drug
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation: Cohort 1 | Experimental | OBI-902 at dose level 1.6 mg/kg, Q3W Receives: Drug: OBI-902 |
| Phase 1a Dose Escalation: Cohort 2 | Experimental | OBI-902 at dose level 3.0 mg/kg, Q3W Receives: Drug: OBI-902 |
| Phase 1a Dose Escalation: Cohort 3 | Experimental | OBI-902 at dose level 4.5 mg/kg, Q3W Receives: Drug: OBI-902 |
| Phase 1a Dose Escalation: Cohort 4 | Experimental | OBI-902 at dose level 6.0 mg/kg, Q3W Receives: Drug: OBI-902 |
| Phase 1a Dose Escalation: Cohort 5 | Experimental | OBI-902 at dose level 8.0 mg/kg, Q3W Receives: Drug: OBI-902 |
| Phase 1a Dose Escalation: Cohort 6 | Experimental | OBI-902 at dose level 10.0 mg/kg, Q3W Receives: Drug: OBI-902 |
| Phase 1b Cohort Expansion: Cohort 1 | Experimental | OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; biliary tract cancer cohort. Receives: Drug: OBI-902 |
| Phase 1b Cohort Expansion: Cohort 2 | Experimental | OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; gastric and gastroesophageal cancer cohort. Receives: Drug: OBI-902 |
| Phase 1b Cohort Expansion: Cohort 3 | Experimental | OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; platinum resistant ovarian cancer cohort. Receives: Drug: OBI-902 |
| Phase 2 Randomized Dose Optimization Cohort: Cohort 1 | Experimental | Randomized dose optimization cohort. Tumor type and/or population will be based on safety/tolerability, PK, and preliminary efficacy of OBI-902 from Phase 1 part of the study. Receives: Drug: OBI-902 |
| Phase 2 Randomized Dose Optimization Cohort: Cohort 2 | Experimental | Randomized dose optimization cohort. Tumor type and/or population will be based on safety/tolerability, PK, and preliminary efficacy of OBI-902 from Phase 1 part of the study. Receives: Drug: OBI-902 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of OBI-902: incidence of adverse events (AEs) and serious adverse events (SAEs), changes in selected clinical laboratory parameters, cardiac parameters, and vital signs.
To assess the safety and tolerability of OBI-902 when administered intravenously to participants with advanced solid tumors
Measured: Duration of study, up to 54 weeks
Maximum tolerated dose (MTD) of OBI-902
To determine the MTD of OBI-902 at which the pre-defined rate of dose limiting toxicities (DLTs) is not exceeded.
Measured: Duration of study, up to 54 weeks
Preliminary antitumor activity of OBI-902 in selected tumor types - Objective Response Rate (ORR)
Percentage of participants with ORR according to RECIST version 1.1 for each cohort
Measured: Duration of study, up to 54 weeks
Preliminary antitumor activity of OBI-902 in selected tumor types - Duration of Response (DoR)
Percentage of participants with DOR according to RECIST version 1.1 for each cohort
Measured: Duration of study, up to 54 weeks
Preliminary antitumor activity of OBI-902 in selected tumor types - Clinical Benefit Rate (CBR)
Percentage of participants with CBR according to RECIST version 1.1 for each cohort
Measured: Duration of study, up to 54 weeks
Preliminary antitumor activity of OBI-902 in selected tumor types - Disease Control Rate (DCR)
Percentage of participants with DCR according to RECIST version 1.1 for each cohort
Measured: Duration of study, up to 54 weeks
Safety and tolerability of OBI-902 in Phase 1b/Phase 2: incidence of AEs, SAEs, and laboratory abnormalities.
To further characterize safety and tolerability of OBI-902 as graded by NCI CTCAE version 5.0.
Measured: Duration of study, up to 54 weeks
Optimal recommended phase 2 dose (RP2D) of OBI-902
To determine the optimal RP2D of OBI-902 for larger Phase 3 trials
Measured: Duration of study, up to 54 weeks
Secondary outcomes (7)
Preliminary long-term efficacy of OBI-902 in selected tumor types
PFS as assessed by the investigator and OS.
Measured: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: Peak Plasma Concentration (Cmax)
To evaluate the serum Cmax of OBI-902 and exatecan
Measured: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: area under the concentration-time curve (AUC)
To evaluate the serum AUC of OBI-902 and exatecan
Measured: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: half-life (T1/2)
To evaluate the serum half-life of OBI-902 and exatecan
Measured: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: clearance (CL)
To evaluate the serum clearance of OBI-902 and exatecan
Measured: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: volume distribution at steady state (Vdss)
To evaluate the serum volume distribution at steady state of OBI-902 and exatecan
Measured: Duration of study, up to 54 weeks
Immunogenicity of OBI-902
To evaluate the immunogenicity of OBI-902 anti-drug antibodies (ADAs)
Measured: Duration of study, up to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start4 Aug 2025
- Primary completion8 Feb 2029 (estimated)
- Study completion8 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OBI Pharma, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124117
- Sponsor's protocol ID
- OBI-902-001
- Status last verified
- Dec 2025
- First submitted
- 4 Aug 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07124117
- Acronym / sponsor ID
- OBI-902-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- OBI Pharma, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 8 Feb 2029 (estimated)
- Study completion
- 8 Feb 2029 (estimated)
- First posted
- 15 Aug 2025 (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 is a 3-part study. Phase 1a (dose escalation) is designed to assess the safety and tolerability and to determine the maximum tolerated dose (MTD) and putative recommended phase 2 dose (RP2D) of study drug as monotherapy. Phase 1b (Cohort Expansion) is intended to further characterize the safety and preliminary antitumor activity of the putative RP2D of OBI-902 in selected tumor types. Phase 2 (Randomized Dose Optimization Cohorts) is intended to determine the optimal RP2D of OBI-902 in selected tumor types, before advancing to larger Phase 3 trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation: Cohort 1 | Experimental | Drug: OBI-902OBI-902 at dose level 1.6 mg/kg, Q3W |
| Phase 1a Dose Escalation: Cohort 2 | Experimental | Drug: OBI-902OBI-902 at dose level 3.0 mg/kg, Q3W |
| Phase 1a Dose Escalation: Cohort 3 | Experimental | Drug: OBI-902OBI-902 at dose level 4.5 mg/kg, Q3W |
| Phase 1a Dose Escalation: Cohort 4 | Experimental | Drug: OBI-902OBI-902 at dose level 6.0 mg/kg, Q3W |
| Phase 1a Dose Escalation: Cohort 5 | Experimental | Drug: OBI-902OBI-902 at dose level 8.0 mg/kg, Q3W |
| Phase 1a Dose Escalation: Cohort 6 | Experimental | Drug: OBI-902OBI-902 at dose level 10.0 mg/kg, Q3W |
| Phase 1b Cohort Expansion: Cohort 1 | Experimental | Drug: OBI-902OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; biliary tract cancer cohort. |
| Phase 1b Cohort Expansion: Cohort 2 | Experimental | Drug: OBI-902OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; gastric and gastroesophageal cancer cohort. |
| Phase 1b Cohort Expansion: Cohort 3 | Experimental | Drug: OBI-902OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; platinum resistant ovarian cancer cohort. |
| Phase 2 Randomized Dose Optimization Cohort: Cohort 1 | Experimental | Drug: OBI-902Randomized dose optimization cohort. Tumor type and/or population will be based on safety/tolerability, PK, and preliminary efficacy of OBI-902 from Phase 1 part of the study. |
| Phase 2 Randomized Dose Optimization Cohort: Cohort 2 | Experimental | Drug: OBI-902Randomized dose optimization cohort. Tumor type and/or population will be based on safety/tolerability, PK, and preliminary efficacy of OBI-902 from Phase 1 part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Male or female participants, 18 years of age or older at the time of consent
- Provide written informed consent prior to performing any study-related procedure
- Histologically or cytologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies
- Participants must have been treated with established standard-of-care therapy, andphysicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy. In the latter case, the source documentation must state the effective therapies the participant is declining.
- Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
Key exclusion criteria (13 listed)
- 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.
- 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.
- Sensory or motor neuropathy of Grade 2 or greater.
- Participants with a history of solid organ transplants. Corneal transplant without immunosuppressive therapy is allowed.
- 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.
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 |
|---|---|---|
| OBI-902OBI-902 is an antibody-drug conjugate study drug | Drug | Phase 1a Dose Escalation: Cohort 1, Phase 1a Dose Escalation: Cohort 2, Phase 1a Dose Escalation: Cohort 3, Phase 1a Dose Escalation: Cohort 4, Phase 1a Dose Escalation: Cohort 5, Phase 1a Dose Escalation: Cohort 6, Phase 1b Cohort Expansion: Cohort 1, Phase 1b Cohort Expansion: Cohort 2, Phase 1b Cohort Expansion: Cohort 3, Phase 2 Randomized Dose Optimization Cohort: Cohort 1, Phase 2 Randomized Dose Optimization Cohort: Cohort 2 |
Primary outcome
Safety and tolerability of OBI-902: incidence of adverse events (AEs) and serious adverse events (SAEs), changes in selected clinical laboratory parameters, cardiac parameters, and vital signs.
Time frame: Duration of study, up to 54 weeks
To assess the safety and tolerability of OBI-902 when administered intravenously to participants with advanced solid tumors
Maximum tolerated dose (MTD) of OBI-902
Time frame: Duration of study, up to 54 weeks
To determine the MTD of OBI-902 at which the pre-defined rate of dose limiting toxicities (DLTs) is not exceeded.
Preliminary antitumor activity of OBI-902 in selected tumor types - Objective Response Rate (ORR)
Time frame: Duration of study, up to 54 weeks
Percentage of participants with ORR according to RECIST version 1.1 for each cohort
Preliminary antitumor activity of OBI-902 in selected tumor types - Duration of Response (DoR)
Time frame: Duration of study, up to 54 weeks
Percentage of participants with DOR according to RECIST version 1.1 for each cohort
Preliminary antitumor activity of OBI-902 in selected tumor types - Clinical Benefit Rate (CBR)
Time frame: Duration of study, up to 54 weeks
Percentage of participants with CBR according to RECIST version 1.1 for each cohort
Preliminary antitumor activity of OBI-902 in selected tumor types - Disease Control Rate (DCR)
Time frame: Duration of study, up to 54 weeks
Percentage of participants with DCR according to RECIST version 1.1 for each cohort
Safety and tolerability of OBI-902 in Phase 1b/Phase 2: incidence of AEs, SAEs, and laboratory abnormalities.
Time frame: Duration of study, up to 54 weeks
To further characterize safety and tolerability of OBI-902 as graded by NCI CTCAE version 5.0.
Optimal recommended phase 2 dose (RP2D) of OBI-902
Time frame: Duration of study, up to 54 weeks
To determine the optimal RP2D of OBI-902 for larger Phase 3 trials
7 secondary outcomes
Preliminary long-term efficacy of OBI-902 in selected tumor types
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: Peak Plasma Concentration (Cmax)
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: area under the concentration-time curve (AUC)
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: half-life (T1/2)
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: clearance (CL)
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: volume distribution at steady state (Vdss)
Time frame: Duration of study, up to 54 weeks
Immunogenicity of OBI-902
Time frame: Duration of study, up to 54 weeks
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 5 Jan 2026.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OBI-902 in people with Advanced Solid Tumor, run by OBI Pharma, Inc at 6 sites in 2 countries.
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 26 inclusion and 13 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 5 Jan 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 United States, Taiwan. 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 OBI Pharma, Inc. Sponsor (1-619-537-7821, clinicaltrials.gov-queries@obipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of OBI-902: incidence of adverse events (AEs) and serious adverse events (SAEs), changes in selected clinical laboratory parameters, cardiac parameters, and vital signs. (time frame: Duration of study, up to 54 weeks). The study lists 8 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 5 Jan 2026; AzTrials last refreshed its copy on 4 Nov 2026.