BIO-106 + Pembrolizumab for Advanced Cancer

Recruiting at 2 trial locations

Overseen By BiOneCure Therapeutics Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BiOneCure Therapeutics Inc.

Must not be taking: Monoclonal antibodies

Disqualifiers: Cardiac disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

332 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for people with advanced cancer. It tests BIO-106, an experimental treatment, both alone and with pembrolizumab, a drug already used in cancer therapy, to evaluate their combined effectiveness. The trial targets individuals with advanced or metastatic solid tumors who have not responded to standard treatments or cannot take them. Participants will receive varying doses of the treatments to assess their effectiveness and safety. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pembrolizumab, one of the drugs in this trial, has a well-documented safety record. Previous studies have thoroughly documented its side effects. It is commonly used for various cancers, such as lung cancer and melanoma, and recent research has not identified any new safety concerns.

For BIO-106, specific safety information is limited. As this trial is in its early stages, researchers are determining the appropriate dose and monitoring for unexpected side effects. These early trials primarily focus on safety to prevent severe adverse effects in participants.

Overall, past research considers pembrolizumab safe, while BIO-106 is still under study to better understand its safety profile. Participants should know that these trials aim to ensure treatments are as safe as possible before wider use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BIO-106 because it offers a novel approach to treating advanced cancer. Unlike current standards like chemotherapy and targeted therapies, BIO-106 works by potentially enhancing the immune system's response to cancer cells when combined with pembrolizumab, an established immunotherapy drug. This combination could lead to more effective cancer suppression by targeting the cancer cells more precisely and helping the body's own defenses fight the disease. For the single-agent arm, BIO-106 is being explored for its ability to target advanced cancers on its own, which could offer new hope for patients who do not respond well to existing treatments.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

In this trial, participants will receive either BIO-106 alone or with pembrolizumab, also known as Keytruda. Studies have shown that pembrolizumab effectively treats several types of advanced cancers by helping the immune system find and attack cancer cells. Research indicates that BIO-106 targets a protein called Trop2, often found in high amounts on cancer cells. By targeting Trop2, BIO-106 may help slow or stop tumor growth. Together, BIO-106 and pembrolizumab might enhance the body's ability to fight cancer more effectively than using either treatment alone. Initial findings suggest this combination could be promising for people with advanced cancers. ^{1 2 3 6 7}

Who Is on the Research Team?

BiOneCure Clinical Development

Principal Investigator

BiOneCure Therapeutics Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I am fully active or can carry out light work.

Exclusion Criteria

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BIO-106

1 year

Multiple visits for dose escalation

Phase 2: Dose Expansion

Evaluate the preliminary efficacy of BIO-106 in combination with pembrolizumab in advanced cancers

2 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIO-106
• Pembrolizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Single agent BIO-106 Experimental Treatment 1 Intervention

Escalating doses followed by expansion targeting advanced cancers

Group II: Combination BIO-106 plus pembrolizumab Experimental Treatment 2 Interventions

Escalating doses followed by expansion targeting advanced cancers

Who Is Running the Clinical Trial?

BiOneCure Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

330+

Published Research Related to This Trial

Pembrolizumab (Keytruda) is approved for treating advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, specifically for patients whose disease has progressed after previous treatments.

This approval is significant for patients who are not candidates for curative surgery or radiation, providing a new therapeutic option for a challenging stage of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Approved Use for Keytruda. Aschenbrenner, DS.[2022]

Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.

A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. Clotman, K., Janssens, K., Specenier, P., et al.[2022]

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.

Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. Karim, S., Leighl, N.[2017]

In a real-life study of 121 patients with advanced non-squamous non-small cell lung cancer, the combination of pembrolizumab and chemotherapy resulted in a median progression-free survival of 9 months and overall survival of 20.6 months, demonstrating its efficacy as a first-line treatment.

The treatment was generally well-tolerated, with manageable side effects; however, 17.5% of patients experienced grade 3-4 adverse events, and there were two treatment-related deaths, indicating the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab plus pemetrexed-carboplatin combination in first-line treatment of advanced non-squamous non-small cell lung cancer: a multicenter real-life study (CAP29). Renaud, E., Ricordel, C., Corre, R., et al.[2023]

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.

The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.

In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]

Pembrolizumab (Keytruda) is an effective treatment for advanced melanoma, showing significant improvements in progression-free survival and overall response rates compared to ipilimumab and chemotherapy in clinical trials involving patients with varying treatment histories.

The drug has a manageable safety profile, with immune-related side effects that are generally reversible, making it a valuable option for patients who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab: A Review in Advanced Melanoma. Deeks, ED.[2022]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating unresectable or metastatic melanoma based on two clinical trials involving 1,374 patients, showing significant improvements in overall survival compared to ipilimumab, with hazard ratios indicating a reduced risk of death.

Patients receiving pembrolizumab also experienced significant improvements in progression-free survival, although some immune-mediated adverse reactions like hypothyroidism and pneumonitis were noted, highlighting the importance of monitoring for side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. Barone, A., Hazarika, M., Theoret, MR., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-2-solid-tumors-advanced-solid-tumors-2-2022-e49ed

BIO-106 + Pembrolizumab for Advanced Cancer Pembrolizumab, also known as Keytruda, has shown effectiveness in treating various advanced cancers, including non-small cell lung cancer and melanoma, by ...

2. synapse.patsnap.com synapse.patsnap.com/drug/517bb2a27a9746d087a6c8a0aefe45e7

BIO-106(BiOneCure) - Drug Targets, Indications, Patents A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11209721/

Trop2-targeted therapies in solid tumors - PubMed Central - NIH This review provides a comprehensive summary of advances in Trop2-targeted therapies, including ADCs, antibodies, multispecific agents, immunotherapy, cancer ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667005425000432

Advancements in antibody-drug conjugates as cancer ... BIO-106, Advanced cancer, I/II, NCT05320588. Datopotamab Deruxtecan (Dato-DXd ... effects can significantly improve therapeutic outcomes in cancer treatment.

5. unitytrials.org unitytrials.org/trials/detail/NCT05320588-a-study-in-patients-with-advanced-cancers

A Study in Patients With Advanced Cancers - Unity Trials A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0959804924000066

Safety profile of pembrolizumab monotherapy based on an ... The results of this large, pooled analysis of data from 31 clinical trials show that pembrolizumab had a consistent safety profile across tumor types.

7. aacrjournals.org aacrjournals.org/clincancerres/article/26/9/2124/83112/Efficacy-and-Safety-of-Pembrolizumab-in-Previously

Efficacy and Safety of Pembrolizumab in Previously Treated ... The safety profile was consistent with that previously observed for pembrolizumab in patients with advanced cancer and no new safety signals were noted.