What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often have a range of side effects. Chemotherapy can cause myelosuppression (leading to neutropenia, anemia, and thrombocytopenia), gastrointestinal issues (nausea, vomiting, diarrhea), and alopecia. Targeted therapies, depending on the specific agent, may cause skin rashes, hypertension, and hepatotoxicity. Immunotherapies, such as checkpoint inhibitors, can lead to immune-related adverse events like colitis, pneumonitis, and endocrinopathies. Agents similar to OBI-999, though not specified, may share side effects common to these categories, including fatigue, infusion reactions, and organ-specific toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, including immunotherapies like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells. Targeted therapies such as bevacizumab, which inhibits angiogenesis, and various tyrosine kinase inhibitors (e.g., sunitinib, erlotinib) have also been approved for different types of solid tumors. Additionally, novel agents like lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, have shown efficacy in specific tumor types. These treatments represent a range of mechanisms aimed at controlling tumor growth and progression.

What other types of research exist?

Promising novel alternatives to OBI-999 for solid tumor patients in 2024 include: 1) Pembrolizumab (an anti-PD-1 therapy) combined with chemotherapy, as shown in the KEYNOTE-189 trial for non-small cell lung cancer. 2) Atezolizumab (an anti-PD-L1 therapy) combined with bevacizumab and chemotherapy, as demonstrated in the IMpower150 trial for non-small cell lung cancer. 3) Cabozantinib (a tyrosine kinase inhibitor) for medullary thyroid cancer, as evidenced by the EXAM trial. 4) Futibatinib (an FGFR inhibitor) for cholangiocarcinoma, based on the FOENIX-CCA2 trial. These therapies have shown significant clinical activity and are expected to be relevant treatment options in 2024.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 to week 106 for reporting.

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 more

Awards & 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).

Do I qualify?Apply below to find out

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].