VVD-130850 for Advanced Cancer

Recruiting at 19 trial locations

Overseen By Vividion Clinical Trial Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vividion Therapeutics, Inc.

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Immunodeficiency, Cardiac diseases, CNS malignancies, others

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

Compensation: Varies

Number of Visits: 2

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, VVD-130850, for individuals with advanced cancers, including solid tumors and some blood cancers like non-Hodgkin's lymphoma. Researchers aim to assess the safety and tolerability of the treatment, both alone and in combination with another cancer drug, pembrolizumab (also known as KEYTRUDA). Participants may receive varying doses to determine the optimal and safest amount. This trial may suit those with advanced cancer who have previously tried other unsuccessful treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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, if you are on immunosuppressive therapy or systematic steroid therapy, you may not be eligible to participate.

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

Researchers are conducting studies to understand the safety and effects of VVD-130850 in the body, both alone and with pembrolizumab, a cancer treatment drug. Currently, detailed safety information from these studies is not available.

This trial is in an early phase, focusing primarily on the safety of VVD-130850. Researchers aim to assess how well participants tolerate the treatment and identify any side effects. They are also examining its interaction with pembrolizumab, which is already approved for some cancers and known to be safe. However, its interaction with VVD-130850 remains under investigation. As the trial progresses, more specific safety information will be collected. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for advanced cancer, which often include chemotherapy or targeted therapies, VVD-130850 works by targeting specific pathways in cancer cells, potentially offering a novel approach to treatment. What sets VVD-130850 apart is that it can be combined with pembrolizumab, a well-known immunotherapy, to enhance the body's immune response against cancer cells. Furthermore, VVD-130850 is administered orally, providing a more convenient option compared to traditional intravenous chemotherapy. Researchers are excited about the potential of VVD-130850 to improve outcomes for patients with advanced cancer, either as a single agent or in combination with pembrolizumab.

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

Research shows that VVD-130850 is a new treatment under study for advanced cancer. This small molecule targets STAT3, a protein that promotes cancer growth. Early lab results suggest it might inhibit cancer cell growth. In this trial, some participants will receive VVD-130850 alone, while others will receive it with pembrolizumab, an approved cancer treatment. Combining VVD-130850 with pembrolizumab aims to enhance the body's immune response against tumors. Pembrolizumab alone has effectively treated some advanced cancers. Together, these treatments could offer new hope for people with difficult-to-treat cancers. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors or blood cancers who have not responded to standard treatments. Participants must be adults, able to give consent, and meet specific health criteria.

Inclusion Criteria

My cancer is advanced and cannot be removed by surgery.

I am fully active or can carry out light work.

My organs and bone marrow are working well.

Exclusion Criteria

I have had a transplant from another person.

I am allergic to pembrolizumab or its ingredients.

I have an immune system disorder or am on medication that weakens my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ascending doses of VVD-130850, orally, once daily, with or without pembrolizumab IV infusion, in 21-day treatment cycles

21 days per cycle

1 visit every 3 weeks

Dose Expansion

Participants receive VVD-130850 at the recommended dose for expansion, orally, once daily, with or without pembrolizumab IV infusion, in 21-day treatment cycles

21 days per cycle

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab
• VVD-130850

Trial Overview The study tests VVD-130850 alone and combined with Pembrolizumab (a checkpoint inhibitor) to assess safety, how the body processes it, and its effects on cancer cells in patients with advanced tumors.

How Is the Trial Designed?

Group I: Dose Expansion: VVD-130850 Single Agent Experimental Treatment 1 Intervention

Participants will receive VVD-130850 at recommended dose for expansion (RDE), orally, once daily in 21-day treatment cycles during the dose expansion phase.

Group II: Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy Experimental Treatment 2 Interventions

Participants will receive VVD-130850 at RDE orally, once daily along with pembrolizumab IV infusion, Q3W in 21-day treatment cycles during the dose expansion phase.

Group III: Dose Escalation: VVD-130850 Single Agent Experimental Treatment 1 Intervention

Participants will receive ascending doses of VVD-130850, orally, once daily in 21-day treatment cycles during the dose escalation phase.

Group IV: Dose Escalation: VVD-130850 + Pembrolizumab Combination Therapy Experimental Treatment 2 Interventions

Participants will receive ascending doses of VVD-130850, orally, once daily, along with pembrolizumab intravenous (IV) infusion, every 3 weeks (Q3W) in 21-day treatment cycles during the dose escalation phase.

Who Is Running the Clinical Trial?

Vividion Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

780+

Published Research Related to This Trial

VM 26 and VP 16-213, epipodophyllotoxin derivatives entering phase III studies, show significant effectiveness against small-cell lung carcinoma and other cancers, particularly in the late S and G2 phases of the cell cycle.

VP 16-213 has demonstrated notable clinical activity in various cancers, including Hodgkin's disease and non-Hodgkin lymphomas, suggesting it may be prioritized over VM-26 for further development and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The epipodophyllotoxin derivatives VM-26 and VP-16-213, 1976-1979, a review. Nissen, NI., Dombernowsky, P., Hansen, HH., et al.[2019]

In a study of 25 patients with advanced ovarian carcinoma, VP-16-213 showed a 22% response rate, including one complete response, indicating its potential effectiveness even in patients previously treated with cis-platinum.

The treatment was well-tolerated with mild toxicity, and the median duration of response was 20 weeks, with a median survival of 32 weeks, suggesting that VP-16-213 warrants further investigation, particularly in combination with cis-platinum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of VP-16-213 in advanced ovarian carcinoma. Hillcoat, BL., Campbell, JJ., Pepperell, R., et al.[2019]

In a study of 27 patients with advanced breast cancer who were resistant to previous treatments, the combination of VP 16-213 and cyclophosphamide resulted in a 15% complete response rate and a 26% partial response rate, indicating its efficacy in difficult-to-treat cases.

Despite its effectiveness, the treatment was associated with significant side effects, including gastrointestinal toxicity in all patients and bone marrow toxicity in 81%, highlighting the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VP16-213 and cyclophosphamide in advanced breast cancer. A phase II study. Estapé, J., Cirera, L., Millá, A., et al.[2019]

VP 16-213, a new semisynthetic epipodophyllotoxin, demonstrated clinically valuable antitumor activity in a phase II trial involving 33 patients with solid tumors and acute leukemias, particularly showing promising results in patients with oat cell carcinoma of the lung.

The drug was generally well tolerated, but it commonly caused side effects like leukothrombopenia and hair loss, indicating a need for further studies to optimize its dosage and explore its use in combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic experiences using the new podophyllotoxin derivative VP 16-213 in malignant human tumors]. Jungi, WF., Senn, HJ., Beckmann, C., et al.[2013]

In a Phase II study involving 14 patients with advanced cervical carcinoma, the combination of VP-16 (etoposide), ifosfamide, and cisplatin (VIP) resulted in complete responses in 8 patients, with response durations lasting between 7 to over 24 months.

The VIP chemotherapy regimen was well-tolerated overall, with manageable hematologic toxicity being the primary side effect, indicating its potential as an effective treatment option for advanced cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etoposide (VP-16), ifosfamide/mesna, and cisplatin chemotherapy for advanced and recurrent carcinoma of the cervix. Kredentser, DC.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06188208

NCT06188208 | A First-in-Human (FIH) Study to Evaluate ... A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint ...

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/vividion-trial-cancer-treatment/

Vividion begins subject dosing in trial of cancer treatment Vividion Therapeutics has dosed the first subject in a Phase I trial of an oral inhibitor, VVD-159642, aimed at treating rat sarcoma (RAS)-driven cancers.

3. withpower.com withpower.com/trial/phase-1-neoplasms-2024-9abc6

VVD-130850 for Advanced Cancer · Info for Participants This trial is testing a new drug called VVD-130850 to see if it is safe and how it behaves in the body. The study focuses on patients with advanced solid and ...

4. vividion.com vividion.com/news/vividion-therapeutics-starts-phase-i-clinical-trial-in-advanced-solid-and-hematologic-tumors-with-oral-stat3-inhibitor/

Vividion Therapeutics starts Phase I clinical trial in ... VVD-130850 is an investigational oral small molecule inhibitor of STAT3 transcription factor developed for treatment of advanced solid and ...

5. synapse.patsnap.com synapse.patsnap.com/blog/vividion-initiates-phase-i-trial-for-oral-stat3-inhibitor-in-advanced-tumors

Vividion Initiates Phase I Trial for Oral STAT3 Inhibitor in ... The trial will assess the safety, tolerability, and preliminary efficacy of VVD-130850, as well as its pharmacokinetic and pharmacodynamic ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT06188208

A First-in-Human (FIH) Study to Evaluate the Safety and ... The Phase I clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of VVD-130850 in ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03477

A First-in-Human (FIH) Study to Evaluate the Safety and ... A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint ...