What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and hematologic toxicities such as neutropenia and anemia. Targeted therapies, like tyrosine kinase inhibitors, may lead to side effects such as hypertension, diarrhea, liver dysfunction, and skin rashes. Immunotherapy, including checkpoint inhibitors, can result in immune-related adverse events like pneumonitis, colitis, hepatitis, and endocrinopathies. These side effects vary in severity and frequency depending on the specific drug and patient characteristics.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of advanced solid tumors. Pembrolizumab, an immune checkpoint inhibitor, has been approved for various solid tumors, including melanoma and non-small cell lung cancer. Atezolizumab, another immune checkpoint inhibitor, has been approved for urothelial carcinoma and non-small cell lung cancer. Additionally, targeted therapies like sunitinib and pazopanib have been approved for renal cell carcinoma. These treatments aim to inhibit tumor growth and improve patient outcomes, similar to the investigational drug ORB-011.

What other types of research exist?

Promising novel alternatives to ORB-011 for solid tumor patients include: <ol> <li>AZD0156: An ATM inhibitor currently in phase I studies, showing potential in combination with olaparib for enhancing treatment efficacy.</li> <li></li> </ol> Atezolizumab plus Bevacizumab: This combination has shown efficacy in various solid tumors, including renal cell carcinoma, in phase III trials. 3. Pembrolizumab: An immune checkpoint inhibitor that has demonstrated effectiveness in multiple solid tumors, including advanced renal cell carcinoma and Merkel cell carcinoma. 4. Niraparib plus Nivolumab or Ipilimumab: This combination is being evaluated in phase 1b/2 trials for platinum-sensitive advanced pancreatic cancer and may have broader applications in solid tumors.

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ORB-011 for Advanced Cancer (ORB Trial)

Phase 1

Recruiting

Research Sponsored by Orionis Biosciences 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 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ORB-011 to see if it is safe for people with advanced solid tumors. The study will also find the best dose of the drug by checking its safety and effectiveness.

Who is the study for?

Adults with advanced solid tumors who have tried or are ineligible for standard treatments can join this trial. They must be in good physical condition (ECOG 0-1), have proper organ and marrow function, and not be pregnant. Participants should agree to use effective contraception during the study.

What is being tested?

The trial is testing ORB-011, a new drug by Orionis Biosciences, for safety and optimal dosing in treating various advanced solid tumors. The study includes screening, treatment phases, and follows up at the end of treatment.

What are the potential side effects?

While specific side effects of ORB-011 aren't listed here, common ones from cancer drugs include fatigue, nausea, diarrhea, blood count changes increasing infection risk; however individual experiences may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine Recommended Phase 2 Dose (RP2D)

Number of Adverse Events (AE) in patients dosed with ORB-011

Secondary study objectives

Collect the number of Dose Limiting Toxicities (DLTs) in patients dosed with ORB-001

Measure Maximum Plasma Concentration [Cmax]).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation ORB-011Experimental Treatment1 Intervention

ORB-011 Dose Escalation Participants will be administered study drug at dose levels corresponding to their Cohort. Cohort 1 will be treated with the lowest dose, and the dose will be escalated for future cohorts once the previous dose has been observed not to be associated with DLTs. Up to 7 dose cohorts have been pre-specified. Doses from the escalation arms will be selected as RP2D candidates.

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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

The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapy involves drugs designed to specifically target molecular abnormalities in cancer cells, such as mutations or overexpressed proteins, thereby minimizing damage to normal cells. Immunotherapy leverages the body's immune system to recognize and attack cancer cells. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most appropriate treatment based on the tumor's specific characteristics and the patient's overall health, potentially improving outcomes and reducing side effects. Investigational drugs like ORB-011 aim to refine these approaches, offering new hope for more effective and tolerable treatments.