NCT07124117 · OBI Pharma, Inc
A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors
What this study is about
This is a 2-part trial: Part A (gradually increasing doses) is designed to establish the maximum tolerated dose (MTD) and putative recommended phase 2 dose of OBI-902 (study drug) as treatment given alone.
View original scientific description
This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and putative recommended phase 2 dose of OBI-902 (study drug) as monotherapy. Part B (Cohort Expansion) is intended to determine the optimal RP2D and further characterize the safety and preliminary clinical activity profile of the OBI-902 RP2D in participants with advanced solid tumors.
Interventions
DRUG
OBI-902
OBI-902 is an antibody-drug conjugate study drug
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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. 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 i. Serum AST ≤3 × ULN,
Where
- La Jolla, California
- Houston, Texas
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 5, 2026 · Source of record for eligibility and locations