BGC515 for Cancer

Overseen By BridGene Biosciences

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BridGene Biosciences Inc.

Must not be taking: TEAD inhibitors

Disqualifiers: Severe systemic disease, CNS metastasis, cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

103 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BGC515 for individuals with advanced solid tumors, including mesothelioma and epithelioid hemangioendothelioma. The main goal is to determine BGC515's safety and its effects on the body. In the first part, researchers will test different doses to identify the optimal amount. The second part will use this dose to evaluate its effectiveness. Individuals with tumors that have grown or not responded well to standard treatments might be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, there is a mention of an 'inadequate wash-out of prior therapies,' which suggests that some medications might need to be stopped before participating. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that BGC515 is likely to be safe for humans?

Research shows that BGC515 is undergoing its first human trials. As this is an early-stage study, detailed safety information is not yet available. The study primarily aims to assess the safety and tolerability of BGC515. Researchers will closely monitor participants' responses and check for side effects.

Currently, no solid information exists about negative side effects from earlier studies. The main goal is to determine the safest dose for humans by gradually increasing the dose while closely monitoring participants.

Prospective participants should know that their safety is a top priority for the researchers. They will stop or adjust the treatment if any serious side effects occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BGC515 because it offers a new approach to tackling cancer. Unlike traditional chemotherapy that broadly attacks rapidly dividing cells, BGC515 is designed to target specific pathways within cancer cells, potentially leading to fewer side effects. Administered in capsule form, it provides the convenience of oral dosing, which is a departure from the usual intravenous infusions. Additionally, its potential effectiveness against rare cancers like malignant mesothelioma and epithelioid hemangioendothelioma makes it a promising option for patients with limited treatment choices.

What evidence suggests that BGC515 might be an effective treatment for cancer?

Research shows that BGC515 is being developed to treat advanced solid tumors, including malignant mesothelioma and epithelioid hemangioendothelioma. The trial includes a Dose Escalation phase, where participants receive BGC515 to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose(s) for Expansion (RDE). In the Dose Expansion phase, participants receive BGC515 at the MTD/RDE. This treatment aims to block a protein called TEAD, which aids tumor growth. Early studies have examined the drug's behavior in the body and its initial effects on tumors. Although data on tumor shrinkage remains limited, the focus on blocking TEAD gives researchers hope for its potential as an effective cancer treatment. Further studies are needed to confirm these early findings and understand its benefits for patients. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with advanced solid tumors, including specific types such as Epithelioid Hemangioendothelioma and Mesothelioma. Participants must meet certain health standards to be eligible.

Inclusion Criteria

At least one measurable lesion

I am fully active or have some restrictions but can still care for myself.

Having signed the written Informed Consent Form

Exclusion Criteria

I have used TEAD inhibitors before.

I am not pregnant or breastfeeding.

Study staff member or relative of a study staff member directly related to this clinical trial, or a subordinate of the Investigator in this trial or an employee of the Sponsor, though not directly related to this trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

BGC515 Capsules administered orally in 21 day cycles, once daily, to determine the Maximum Tolerated Dose (MTD) and Recommended Dose(s) for Expansion (RDE)

3 weeks per cycle

Dose Expansion

BGC515 Capsules administered orally in 21 day cycles at MTD/RDE defined dose, once daily, in patients with specific advanced solid tumors

3 weeks per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 1 year

What Are the Treatments Tested in This Trial?

Interventions

• BGC515

Trial Overview The study tests BGC515 capsules given daily in 3-week cycles to see how safe they are, how the body processes them, and if they work against solid tumors.

How Is the Trial Designed?

Group I: Dose Expansion Experimental Treatment 1 Intervention

BGC515 Capsules will be administered orally in 21 day cycles at MTD/RDE defined dose,once daily (QD), in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors.

Group II: Dose Escalation Experimental Treatment 1 Intervention

BGC515 Capsules will be administered orally in 21 day cycles, once daily (QD). Patients will be enrolled into escalating dose levels during the Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose(s) for Expansion (RDE).

Who Is Running the Clinical Trial?

BridGene Biosciences Inc.

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

Ongoing research is identifying potential tumor markers for bladder carcinoma, such as c-erb B-2 and p53, which could improve diagnosis and treatment strategies.

Bacillus Calmette-Guerrin (BCG) treatment is highlighted as a highly effective immunotherapy for superficial bladder cancer, but more research is needed to determine optimal dosing and understand its mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder cancer. Ozen, H.[2019]

A novel oncolytic virus, VSVd51-hGM-CSF, shows promise as a bladder-sparing therapy for aggressive bladder cancer, enhancing immune responses and reducing tumor volume in mouse models.

The therapy demonstrated effective activation of immune cells and improved survival rates, indicating its potential as a treatment option for patients with Bacillus Calmette Guerin refractory disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical immunotherapy with a GM-CSF armed oncolytic vesicular stomatitis virus improves outcome in bladder cancer. Rangsitratkul, C., Lawson, C., Bernier-Godon, F., et al.[2022]

The bispecific antibody anti-CD3 x anti-CD155 (CD155Bi-Ab) effectively enhances the cytotoxic activity of activated T cells against bladder cancer cells, demonstrating increased effectiveness compared to unarmed T cells.

Even in the presence of immunosuppression and drug resistance in bladder cancer patients, CD155Bi-Ab-armed T cells showed significant anti-tumor effects and higher activation markers, indicating that CD155 is a promising target for immunotherapy in treating bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting immunotherapy for bladder cancer by using anti-CD3 × CD155 bispecific antibody. Ma, W., Ma, J., Lei, T., et al.[2020]

CD155 is significantly up-regulated in muscle-invasive bladder cancer (MIBC) and its high expression is associated with shorter recurrence-free and overall survival in a study of 228 patients, indicating its potential as a prognostic marker.

High levels of CD155 expression may help predict which patients with MIBC will benefit from adjuvant chemotherapy, particularly in those with advanced stages (III and IV) of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poliovirus receptor CD155 is up-regulated in muscle-invasive bladder cancer and predicts poor prognosis. Zhang, J., Zhu, Y., Wang, Q., et al.[2021]

In a study of 102 patients with superficial bladder cancer treated with BCG, pretreatment p53 nuclear overexpression was found to be significantly associated with a higher risk of disease recurrence, progression, and cancer death, indicating its potential as a prognostic marker.

The study demonstrated that p53 overexpression can serve as an independent predictor of recurrence, suggesting that patients with high levels of p53 may require closer monitoring or alternative treatments due to their increased risk of poor outcomes after BCG therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretreatment p53 nuclear overexpression as a prognostic marker in superficial bladder cancer treated with Bacillus Calmette-Guérin (BCG). Saint, F., Le Frere Belda, MA., Quintela, R., et al.[2006]

Citations

1. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2024-0264.html

A phase I clinical study to evaluate the safety, tolerability ... A phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 capsules in patients with advanced solid ...

2. smartpatients.com smartpatients.com/trials/NCT06452160

A Study of BGC515 Capsules in Subjects With Advanced ... The goal of this open-label, dose escalation and dose expansion Phase I clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary ...

3. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/bgc-515-bridgene-biosciences-malignant-mesothelioma-likelihood-of-approval/

BGC-515 by BridGene Biosciences for Malignant ... BGC-515 is under development for the treatment of advanced solid tumors which include metastatic mesothelioma (MM) and epithelioid ...

4. fightehe.org fightehe.org/ehe-clinical-trials/

EHE Clinical Trials Trial No. NCT06452160. Description, A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors. Sponsor, BridGene Biosciences. Trial No. NCT06680401.

5. firstwordpharma.com firstwordpharma.com/story/5871342

BridGene Biosciences Announces Dosing of First Patient in ... BridGene Biosciences Announces Dosing of First Patient in Phase 1 Study Evaluating Novel TEAD Inhibitor BGC515 in Advanced Solid Tumors. Press ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT06452160

A Study of BGC515 Capsules in Subjects With Advanced ... The Phase 1 study will enroll subjects in both the US and China (NCT06452160) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and ...

7. ctv.veeva.com ctv.veeva.com/study/a-phase-i-clinical-study-of-bgc515-capsules-in-patients-with-advanced-solid-tumors

A Study of BGC515 Capsules in Subjects With Advanced ... BGC515 Capsules will be administered orally in 21 day cycles at MTD/RDE defined dose,once daily (QD), in patients with malignant mesothelioma ( ...

8. biospace.com biospace.com/bridgene-biosciences-announces-dosing-of-first-patient-in-phase-1-study-evaluating-novel-tead-inhibitor-bgc515-in-advanced-solid-tumors

BridGene Biosciences Announces Dosing of First Patient in ... BridGene Biosciences Announces Dosing of First Patient in Phase 1 Study Evaluating Novel TEAD Inhibitor BGC515 in Advanced Solid Tumors. June 28 ...