BGC515 for Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: BridGene Biosciences Inc.
Must not be taking: TEAD inhibitors
Disqualifiers: Severe systemic disease, CNS metastasis, cardiovascular disease, others
No Placebo Group
Trial Summary
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.
12345Eligibility Criteria
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.
I am 18 years old or older.
+4 more
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
+5 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 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 EscalationExperimental Treatment1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
BridGene Biosciences Inc.Lead Sponsor
References
Poliovirus receptor CD155 is up-regulated in muscle-invasive bladder cancer and predicts poor prognosis. [2021]To investigate the expression pattern of CD155 and evaluate the prognostic value of CD155 in muscle-invasive bladder cancer (MIBC).
Targeting immunotherapy for bladder cancer by using anti-CD3 × CD155 bispecific antibody. [2020]To investigate whether CD155 is an attractive target for T cell-mediated immunotherapy against human bladder cancer, we examined the novel bispecific antibody anti-CD3 x anti-CD155 (CD155Bi-Ab) for its ability to redirect activated T cells (ATCs) to target bladder cancer cells was examined. Expression of CD155 was detected by flow cytometry on the surface of bladder cancer cells, including T24 and Pumc-91 cells, and their chemotherapeutic drug-resistant counterparts. ATCs generated from healthy donors were stimulated with anti-CD3 monoclonal antibody, anti-CD28 monoclonal antibody and interleukin-2 (IL-2) for 14 days. The cytotoxic activity of ATCs armed with CD155Bi-Ab against bladder cancer cells was detected by LDH and luciferase quantitative assay. Furthermore, ATCs generated from bladder cancer patients were also armed with CD155Bi-Ab to verity the cell killing by the same methods. In contrast to unarmed ATCs, CD155Bi-armed ATCs against bladder cancer cells were increased cytotoxic activity at effector/target (E/T) ratios of 5:1, 10:1, and 20:1, with more IFN-γ, TNF-α secreting. It is worth noting that in spite of the presence of immunosuppression in bladder cancer patients and the drug resistance in chemotherapeutic drug-resistant cancer cell lines, not only the anti-tumor effect of CD155Bi-armed ATCs generated from bladder cancer patients still showed significantly but only higher level of activation marker CD69 was expressed. Taken together, our results suggest that CD155 is an effective target for the CD155-positive bladder cancer. And CD155Bi-Ab-armed ATCs are promisingly to provide a novel strategy for current CD155-positive bladder cancer therapy.
Pretreatment p53 nuclear overexpression as a prognostic marker in superficial bladder cancer treated with Bacillus Calmette-Guérin (BCG). [2006]Altered p53 gene product correlates with the stage and grade of bladder tumor, but its value as a predictor of BCG response has been disappointing. In order to revisit the prognostic value of pretreatment p53 nuclear overexpression for the BCG response, we studied a large cohort of consecutive patients with superficial bladder cancer treated with BCG.
Bladder cancer. [2019]In the search for sensitive and specific tumor markers for bladder carcinoma, expression of various oncogenes and gene products (such as c-erb B-2, p53) and epidermal growth factor receptor merits particular attention. Although the results are not yet conclusive, important predictive markers are about to emerge from ongoing studies in this field. Bacillus Calmette-Guerrin treatment in superficial bladder cancer is probably the most successful immunotherapy in humans. But there is still a large knowledge deficit in the issues of optimal dose schedule and mechanisms of action. Although promising results of neoadjuvant chemotherapy in patients with invasive bladder cancers are reported, we must be cautious about changing our conventional approach until the results of large scale, controlled, randomized studies evaluating the survival are published.
Intravesical immunotherapy with a GM-CSF armed oncolytic vesicular stomatitis virus improves outcome in bladder cancer. [2022]A significant proportion of non-muscle invasive bladder cancer cases will progress to muscle invasive disease. Transurethral resection followed by Bacillus Calmette Guerin immunotherapy can reduce this risk, while cystectomy prior to muscle invasion provides the best option for survival. Currently, there are no effective treatments for Bacillus Calmette Guerin refractory disease. A novel oncolytic vesicular stomatitis virus containing the human GM-CSF transgene (VSVd51-hGM-CSF) was rescued and tested as a potential bladder-sparing therapy for aggressive bladder cancer. The existing variant expressing mouse GM-CSF was also used. Measurement of gene expression and protein level alterations of canonical immunogenic cell death associated events on mouse and human bladder cancer cell lines and spheroids showed enhanced release of danger signals and immunogenic factors following infection with VSVd51-m/hGM-CSF. Intravesical instillation of VSVd51-mGM-CSF into MB49 bladder cancer bearing C57Bl/6 mice demonstrated enhanced activation of peripheral and bladder infiltrating effector immune cells, along with improved survival and reduced tumor volume. Importantly, virus-mediated anti-tumor immunity was recapitulated in bladder cancer patient-derived organoids. These results suggest that VSVd51-hGM-CSF is a promising viro/immunotherapy that could benefit bladder cancer patients.