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?

The goal of this open-label, dose escalation and dose expansion Phase I clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 administered once daily in 3 weeks cycles in solid tumor patients.

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.

How does the drug BGC515 differ from other treatments for bladder cancer?

The research does not provide specific information about BGC515, but it highlights the potential of targeting CD155 in bladder cancer treatment, which is a novel approach compared to traditional therapies. This suggests that BGC515 might involve a unique mechanism related to CD155 targeting, setting it apart from existing treatments. ^{1 2 3 4 5}

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

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Poliovirus receptor CD155 is up-regulated in muscle-invasive bladder cancer and predicts poor prognosis. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

Targeting immunotherapy for bladder cancer by using anti-CD3 × CD155 bispecific antibody. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pretreatment p53 nuclear overexpression as a prognostic marker in superficial bladder cancer treated with Bacillus Calmette-Guérin (BCG). [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Bladder cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Intravesical immunotherapy with a GM-CSF armed oncolytic vesicular stomatitis virus improves outcome in bladder cancer. [2022]