SNV1521 for Advanced Cancer

Recruiting at 8 trial locations

Overseen By Robert Casper

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Synnovation Therapeutics, Inc.

Disqualifiers: Brain metastasis, Other malignancy, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the new medicine SNV1521 for individuals with advanced cancers, aiming to determine its safety, tolerability, and effectiveness in treating solid tumors. Researchers are testing various doses to identify the optimal one and assessing its compatibility with other cancer treatments. The trial is suitable for those with advanced or metastatic solid tumors who can perform everyday activities independently. 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.

Do I need to stop my current medications for the trial?

The trial information does not specify if 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 SNV1521 is likely to be safe for humans?

Research shows that SNV1521 is being tested for safety and tolerance in people with advanced cancers. As a new treatment, detailed safety information is still being gathered. In this Phase 1 trial, the main goal is to determine SNV1521's safety when administered to humans for the first time. Researchers closely monitor any side effects participants might experience.

Early studies of similar treatments have reported mild side effects, such as fatigue or nausea. While serious side effects can occur, researchers diligently monitor and manage these.

If SNV1521 receives future approval, it will have undergone extensive testing to ensure safety. Currently, this trial is a crucial step in understanding how people react to SNV1521. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for advanced cancer?

SNV1521 is unique because it targets advanced cancers, including those resistant to traditional treatments. Most existing options, like chemotherapy and radiation, attack rapidly dividing cells broadly, but SNV1521 is designed to be more precise, potentially reducing damage to healthy cells. Researchers are excited because this precision could mean fewer side effects and better outcomes for tough-to-treat cancers, like metastatic prostate cancer, pancreatic ductal adenocarcinoma, and solid tumors with brain metastases. Such targeted therapy represents a promising shift in cancer treatment, offering hope for those with limited options.

What evidence suggests that SNV1521 might be an effective treatment for advanced cancer?

Research has shown that SNV1521 targets a protein called PARP1. These drugs can help fight cancer by preventing cancer cells from repairing their DNA, slowing their growth or killing them. Early findings suggest SNV1521 can reach the brain, potentially treating cancers that have spread there. This trial will enroll participants in various treatment arms, including dose escalation and dose expansion for specific cancers such as metastatic castration-resistant prostate cancer, pancreatic ductal adenocarcinoma, and solid tumors with brain metastases. Although human studies provide limited information, the focus remains on its potential to treat solid tumors, including challenging ones like pancreatic cancer and prostate cancer that have spread to the brain. Early studies aim to find the best dose that is both safe and effective. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with advanced solid tumors that are measurable, who have tried other treatments without success or can't tolerate them. Participants should be relatively active and mobile (ECOG status 0 or 1) and expected to live more than three months.

Inclusion Criteria

Life expectancy > 3 months

Evaluable or Measurable disease (RECIST 1.1 Criteria)

My cancer has spread beyond its original location.

Exclusion Criteria

I have a serious stomach or intestine condition.

I have liver problems.

I have active cancer spread to my brain or its coverings.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of SNV1521 to determine the maximum tolerated dose

28 days

Dose Expansion

Participants receive SNV1521 at the determined dose to evaluate safety and efficacy in specific cancer types

Up to 13 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SNV1521

Trial Overview The study is testing SNV1521, a new medication for advanced cancers. It aims to determine the safety, tolerability, and effectiveness of SNV1521 by exploring different doses to find the best balance between efficacy and safety.

How Is the Trial Designed?

Group I: Dose Expansion for Solid Tumors with Brain Metastases Experimental Treatment 1 Intervention

Group II: Dose Expansion for Pancreatic Ductal Adenocarcinoma Experimental Treatment 1 Intervention

Group III: Dose Expansion for Metastatic Castration Resistant Prostate Cancer Experimental Treatment 1 Intervention

Group IV: Dose Expansion Experimental Treatment 1 Intervention

Group V: Dose Escalation Experimental Treatment 1 Intervention

Group VI: Combination Dose Escalation Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Synnovation Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

340+

Published Research Related to This Trial

In a study of 179 colorectal cancer patients, high CD151 expression was found in 48% of early-stage cases, but only 33% in those with metastatic colon cancer, suggesting that CD151 may play a role in the progression of the disease.

The research indicates that as tumor invasion and metastatic stages increase, CD151 expression decreases, highlighting its potential as a biomarker for assessing cancer progression in colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic change of tetraspanin CD151 membrane protein expression in colorectal cancer patients. Lin, PC., Lin, SC., Lee, CT., et al.[2017]

CD151 is a crucial protein that plays multiple roles in cancer progression, including supporting tumor growth and metastasis, making it a significant target for cancer therapies.

Reducing the interaction of CD151 with integrins can decrease cancer cell invasion and metastasis, suggesting that targeting CD151 could be an effective strategy in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD151-A Striking Marker for Cancer Therapy. Kumari, S., Devi, G., Badana, A., et al.[2020]

In a study using the MMTV-Wnt1 mouse model, the removal of CD151 alleles significantly reduced tumor-free survival from an average of 34 weeks to 22 and 18 weeks, indicating that CD151 plays a crucial role in suppressing tumor growth in breast cancer.

CD151 deficiency led to hyperactivation of the Wnt pathway and changes in cell characteristics, such as increased proliferation and decreased expression of myoepithelial markers, suggesting that CD151 helps counteract processes like epithelial-mesenchymal transition (EMT) that promote cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deletion of tetraspanin CD151 alters the Wnt oncogene-induced mammary tumorigenesis: A cell type-linked function and signaling. Li, H., Li, J., Han, R., et al.[2020]

In a post-marketing survey of 4,177 patients with advanced gastric cancer, S-1 demonstrated a safety profile consistent with earlier studies, with 74% experiencing adverse events and 25% experiencing grade 3 or worse events.

The median survival time for patients treated with S-1 was 8.3 months, with a 1-year survival rate of 33.3%, indicating its efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Japanese nationwide post-marketing survey of S-1 in patients with advanced gastric cancer]. Ohtsu, A.[2013]

In a late phase II clinical study involving 81 patients with advanced or refractory breast cancer, S-1 demonstrated a response rate of 42.0%, with a median survival period of 910 days, indicating its potential effectiveness as a treatment.

S-1 was associated with manageable adverse reactions, with severe side effects occurring in a small percentage of patients, suggesting it has a favorable safety profile compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A late phase II clinical study of S-1 in patients with progressed, refractory breast cancer]. Saeki, T., Takashima, S., Sano, M., et al.[2013]

In a study involving 10 children with various types of leukemia and histiocytic medullary reticulosis, VP 16-213 combined with other drugs showed effectiveness, particularly in acute non-lymphocytic leukemia, where one patient achieved complete response after treatment adjustments.

The treatment regimen caused significant side effects, including severe pancytopenia and vomiting, highlighting the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[VP 16-213 in the treatment of acute leukemia in childhood]. Esumi, N., Arakawa, S., Imashuku, S.[2013]

In a phase II clinical trial involving 71 patients with lung cancer, VP-16-213 showed a 33.3% partial response rate in patients with small cell carcinoma, indicating its potential efficacy for this type of cancer.

The treatment was associated with manageable side effects, primarily leukopenia, nausea, vomiting, anorexia, and alopecia, suggesting that while it is effective, careful monitoring and possible dose adjustments may be necessary in future combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A phase II study of intravenous VP-16-213 in small cell and non-small cell carcinoma of the lung]. Konno, K., Nagahama, F., Nakai, Y., et al.[2013]

In a study of 29 heavily pretreated non-Hodgkin lymphoma (NHL) patients, oral VP 16 showed significant activity with a combined complete response (CR) and partial response (PR) rate of 31%, with responses lasting up to 185 weeks.

For small cell lung cancer (SCLC), a combination treatment of VP 16 with other drugs resulted in a high CR rate of 90% in patients with limited disease and a median survival time exceeding one year for those who achieved CR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[VP 16-213]. Ogawa, M.[2013]

CD151 plays a crucial role in breast cancer progression by regulating the interaction between ErbB2 and ErbB3, which affects how cancer cells respond to Herceptin (trastuzumab).

In clinical studies, CD151 was associated with improved overall and progression-free survival in patients with ErbB2-overexpressing tumors that were ErbB3-negative, highlighting its potential as a biomarker for treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tetraspanin CD151 impairs heterodimerization of ErbB2/ErbB3 in breast cancer cells. Mieszkowska, M., Piasecka, D., Potemski, P., et al.[2019]

Knocking down the CD151 gene in breast cancer cell lines (MCF-7 and MDA-MB-468) significantly reduces their ability to proliferate, migrate, and invade, indicating that CD151 plays a crucial role in promoting aggressive cancer behaviors.

The study suggests that targeting CD151 could be a promising therapeutic strategy for treating luminal and basal-like breast cancer subtypes, as its silencing leads to increased apoptosis and cell cycle arrest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting CD151 by lentivirus-mediated RNA interference inhibits luminal and basal-like breast cancer cell growth and invasion. Liu, T., wang, S., Wang, L., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06220864?draw=2&rank=1

SNV1521 in Participants with Advanced Solid Tumors Advanced or metastatic solid tumor malignancy; Evaluable or Measurable disease (RECIST 1.1 Criteria). ECOG Performance Status 0 or 1. Life expectancy > 3 months.

2. withpower.com withpower.com/trial/phase-1-neoplasms-3-2024-acf49

SNV1521 for Advanced Cancer Trial Overview The study is testing SNV1521, a new medication for advanced cancers. It aims to determine the safety, tolerability, and effectiveness of SNV1521 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6982515/

Three cases of brain metastasis from castration‐resistant ... Brain metastasis from prostate cancer may be becoming more common and may be associated with occurrence of diffuse systemic metastases.

4. bioworld.com bioworld.com/content/phase1-data-2024

Phase I clinical trial data of biopharma companies in 2024 Synnovation Therapeutics Inc., of Wilmington, Del. SNV-1521, Selective and CNS penetrant PARP1 inhibitor, Solid tumors, First patient dosed, 3/11/2024 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8606164/

Pancreas Cancer: Therapeutic Trials in Metastatic Disease Metastatic pancreatic adenocarcinoma (PDAC) is a major cause of cancer-related mortality in 2021. Cytotoxic therapies are the therapeutic mainstay for PDAC.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06220864

SNV1521 in Participants with Advanced Solid Tumors Advanced or metastatic solid tumor malignancy; Evaluable or Measurable disease (RECIST 1.1 Criteria). ECOG Performance Status 0 or 1. Life expectancy > 3 months.

7. ctv.veeva.com ctv.veeva.com/study/snv1521-in-participants-with-advanced-solid-tumors

SNV1521 in Participants with Advanced Solid Tumors This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, ...

8. cancer.gov cancer.gov/clinicaltrials/NCI-2024-03474

SNV1521 in Participants with Advanced Solid Tumors - NCI ... SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one ...

9. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/parp1-inhibitor-snv1521?pn=1

Clinical Trials Using PARP1 Inhibitor SNV1521 - NCI NCI supports clinical trials that test new and more effective ways to treat cancer. Find clinical trials studying parp1 inhibitor snv1521.