Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This is a dose escalation and dose expansion study to evaluate how safe, tolerable and effective a STAT3 Inhibitor called VVD-130850 is by itself, and in combination with immunotherapy (called pembrolizumab) in people with advanced solid tumours or advanced non-Hodgkin's lymphoma (NHL).
There are two stages to the study: Dose Escalation and Dose Expansion. Each stage has two treatment arms.
Dose Escalation arms:
- VVD-130850 single agent: Participants will receive ascending doses of VVD-130850, given as oral tablets once daily.
- VVD-130850 + pembrolizumab: Participants will receive ascending doses of VVD-130850, given as oral tablets once daily, along with pembrolizumab intravenous (IV) infusion every 3 weeks.
Dose Expansion arms:
- VVD-130850 single agent: Participants will receive VVD-130850 at the recommended dose for expansion (RDE) orally once daily.
- VVD-130850 + pembrolizumab: Participants will receive VVD-130850 at the RDE orally, once daily along with pembrolizumab IV infusion once every 3 weeks.
Conditions
This trial is treating people with advanced solid cancers or non-Hodgkin lymphomas
Eligibility
Inclusion
- Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Adequate organ and bone marrow function as defined in the protocol.
-
For Combination Therapy Expansion:
- Serine/threonine kinase 11/ liver kinase B1 (STK11/LKB1) mutated non-small cell lung cancer (NSCLC) as assessed by historical (local) test.
- Must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor (CPI). These therapies could have been given in the same line of therapy or different lines of therapy.
- Measurable disease by RECIST version 1.1 as assessed by the Investigator.
Exclusion
- Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
- Prior allogeneic transplantation.
- History of cardiac diseases as defined in detail in the protocol.
- Clinically significant infection or any eye infection.
- Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
-
Combination Therapy Expansion:
- Known hypersensitivity or contraindication to pembrolizumab or any of its components.
- Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation with the exception of the history of immunotherapy-related endocrinopathy controlled with ongoing medical management (e.g., hypothyroidism, adrenal insufficiency, diabetes).
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Vividion Therapeutics, Inc.
Scientific Title
A Phase 1, Open-Label, 2-Part, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of the STAT3 Inhibitor VVD-130850 as Single Agent and in Combination With Checkpoint Inhibition in Participants With Advanced Solid and Hematologic Tumors
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information