OBI-902 for Advanced Solid Tumors
This study is testing a drug called OBI-902 in people with advanced solid tumors that cannot be cured with standard treatments. OBI-902 is an antibody-drug conjugate, which is a type of targeted therapy. The main goals are to find out how safe OBI-902 is, what dose works best, and if it can shrink tumors. The study is currently unclear about its recruitment status and plans to enroll about 147 participants. To join, you must be at least 18 years old and have a confirmed advanced solid tumor.
- Study design
- This is a three-part study (Phase 1a, 1b, and 2) designed to find the best dose and assess the safety and anti-tumor activity of OBI-902 as a single treatment. It plans to enroll 147 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and tumor activity will be measured for the duration of the study, up to 54 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors
At a glance
Conditions
Where it's being run
6 sites across 5 statesWho to contact
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Inclusion
What this trial 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.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-902Duration 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)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)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)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)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.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-902Duration of study, up to 54 weeks
To determine the optimal RP2D of OBI-902 for larger Phase 3 trials