What side effects are associated with this type of intervention?

Common cancer treatments, including chemotherapy, immunotherapy, and targeted therapies, have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased infection risk. Immunotherapy, such as pembrolizumab, may lead to fatigue, rash, diarrhea, and severe immune-related conditions like pneumonitis. Targeted therapies can result in skin reactions, hypertension, and gastrointestinal issues. The specific side effects depend on the drug and individual patient response.

What prior FDA approvals exist?

Recent FDA approvals for cancer treatments include several immunotherapy and targeted therapy agents. Pembrolizumab, an anti-PD-1 antibody, has been approved for various cancers, including melanoma and head and neck cancer, often in combination with other agents like cetuximab. Nivolumab, another anti-PD-1 antibody, is approved for use in combination with ipilimumab for advanced melanoma. Targeted therapies such as olaparib, a PARP inhibitor, are approved for ovarian cancer. These treatments, like the investigational agent BIO-106, aim to enhance the immune response or target specific molecular pathways in cancer cells.

What other types of research exist?

Promising novel alternatives to BIO-106 for cancer patients considering treatment in 2024 include: <ol> <li>Pembrolizumab (Keytruda) - an anti-PD-1 antibody used alone or in combination with other agents for various cancers, including non-small cell lung cancer and head and neck cancer.</li> <li></li> </ol> Regorafenib - a multitargeted kinase inhibitor showing activity in advanced osteosarcoma. 3. Venetoclax - a BCL-2 inhibitor used in combination with obinutuzumab for chronic lymphocytic leukemia. 4. Acalabrutinib - a BTK inhibitor used for chronic lymphocytic leukemia. 5. Tipifarnib - a farnesyltransferase inhibitor showing promise in HRAS mutant squamous cell carcinoma of the head and neck. 6. Metronomic chemotherapy - an investigational approach using frequent, lower doses of chemotherapy to target tumor angiogenesis.

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Other

BIO-106 + Pembrolizumab for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by BiOneCure Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients histologically or cytologically documented, locally advanced or metastatic solid tumor

Measurable disease as determined by RECIST v.1.1 or bone only disease

Must not have

Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection

Impaired cardiac function or history of clinically significant cardiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, BIO-106, alone and with an existing cancer drug, in patients with advanced cancers. It aims to find a safe dosage and see if these treatments can help patients whose cancers are hard to treat.

Who is the study for?

This trial is for adults with advanced cancers that have worsened after standard treatment or those who can't handle or aren't allowed to get standard care. They should be able to perform daily activities with ease or with some limitation (ECOG status 0-1) and must have measurable cancer growth. People with HIV, hepatitis B/C, severe allergies to the drugs being tested, significant heart issues, active COVID-19, or untreated brain tumors cannot join.

What is being tested?

The study is testing BIO-106 alone and combined with pembrolizumab in patients whose cancers have progressed significantly. Pembrolizumab is an established cancer drug while BIO-106 is new; their effects together are unknown and this first-in-human trial aims to discover how well they work against advanced solid tumors.

What are the potential side effects?

Pembrolizumab may cause immune system reactions affecting organs, fatigue, skin rash, diarrhea among others. BIO-106's side effects are not fully known yet due to its experimental nature but could include similar immune-related conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread and was confirmed by a lab test.

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My cancer can be measured by scans or is only in my bones.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV, active hepatitis B, or hepatitis C.

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I have heart problems or a history of serious heart disease.

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I have not received treatment for tumors or cancer spread to my brain or spinal cord.

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I am currently infected with COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2)

Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)

+1 more

Secondary study objectives

Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 1)

Incidence of adverse event of special interest (AESI) - (Phase 2)

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)

+3 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: Single agent BIO-106Experimental Treatment1 Intervention

Escalating doses followed by expansion targeting advanced cancers

Group II: Combination BIO-106 plus pembrolizumabExperimental Treatment2 Interventions

Escalating doses followed by expansion targeting advanced cancers

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 7Eligibility criteria met

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 cancer treatments work through various mechanisms. Immune checkpoint inhibitors like pembrolizumab enhance the immune system's ability to target cancer cells by blocking the PD-1 pathway. Chemotherapy targets rapidly dividing cells, while targeted therapies focus on specific molecular abnormalities in cancer cells. Radiation therapy damages the DNA of cancer cells, leading to cell death. Understanding these mechanisms helps in tailoring treatments to individual patients, potentially improving efficacy and reducing side effects.

Current trends and future directions in the genetic therapy of human neoplastic disease.Current status of molecular-targeted drugs for endometrial cancer (Review).