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Monoclonal Antibodies
OBI-999 for Advanced Cancers
Phase 1 & 2
Waitlist Available
Led By Apostolia Tsimberidou, MD, PhD
Research Sponsored by OBI Pharma, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 to week 106
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called OBI-999 on its own. It focuses on patients with advanced solid tumors who need new treatment options. The goal is to find out the highest safe dose and see if the drug helps in treating the tumors.
Who is the study for?
This trial is for adults with advanced solid tumors, specifically pancreatic, esophageal, gastric, or colorectal cancer. Participants must have tried standard treatments without success or declined them and have a good performance status (able to carry out daily activities). They need functioning major organs and agree to use contraception. Those with HIV or hepatitis are eligible under certain conditions.
What is being tested?
The study tests OBI-999 as a solo treatment to find the highest dose patients can tolerate without severe side effects (MTD) and the recommended dose for future Phase 2 trials (RP2D). It also aims to understand how safe OBI-999 is and its preliminary effectiveness in shrinking or controlling tumor growth.
What are the potential side effects?
Specific side effects of OBI-999 aren't listed but typically include reactions related to the immune system's response, potential organ inflammation due to drug toxicity, general discomforts like fatigue or nausea, and possibly changes in blood counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1 to week 106
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 to week 106
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Identification of a maximum tolerated dose and recommended phase 2 dose for OBI-999
Measurement of dose-limiting toxicities (DLTs)
Secondary study objectives
Measurement of OBI-999 immunogenicity (anti-drug antibodies ([ADAs]) in patients
Measurement of preliminary clinical activity profile (clinical benefit rate [CBR]) of OBI-999 in patients.
Measurement of preliminary clinical activity profile (duration of response (DOR)]) of OBI-999 in patients.
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: OBI-999 Expansion PhaseExperimental Treatment1 Intervention
Part B: Five cohorts of patients at RP2D of OBI-999 liquid form, as determined from Part A, via IV infusion.
Group II: OBI-999 Escalation phaseExperimental Treatment1 Intervention
Part A: Five cohorts at escalating dose levels 0.4, 0.8, 1.2, 1.6 and 2.0 mg/kg (capping calculations at a maximum at 100 kg) of OBI-999 liquid form via IV infusion to establish maximum tolerated dose (MTD) and Recommended phase 2 dose (RP2D).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects healthy cells, leading to side effects.
Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells.
Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment, managing side effects, and improving overall outcomes. New treatments like OBI-999, though not specified, likely aim to exploit specific vulnerabilities in cancer cells, offering hope for more effective and personalized cancer care.
[Pancreatic cancer: ten years of systemic therapy].
[Pancreatic cancer: ten years of systemic therapy].
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Who is running the clinical trial?
OBI Pharma, IncLead Sponsor
8 Previous Clinical Trials
1,451 Total Patients Enrolled
Apostolia Tsimberidou, MD, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
114 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- This study is specifically for people with pancreatic cancer.You have previously received treatment specifically targeting Globo H.You are allergic to OBI 999 or any of its ingredients.You have a serious heart condition like heart failure or unstable angina.This study is looking for people with esophageal cancer to participate in Cohort 2.This clinical trial is for people with gastric cancer specifically.This study is specifically looking for people with colorectal cancer.You have moderate or worse nerve damage affecting your ability to feel or move.
Research Study Groups:
This trial has the following groups:- Group 1: OBI-999 Expansion Phase
- Group 2: OBI-999 Escalation phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.