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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06188208




Registration number
NCT06188208
Ethics application status
Date submitted
13/12/2023
Date registered
3/01/2024

Titles & IDs
Public title
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors
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
Secondary ID [1] 0 0
2023-508386-32-00
Secondary ID [2] 0 0
VVD-130850-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Advanced Hematologic Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VVD-130850
Treatment: Drugs - Pembrolizumab

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

Experimental: Dose Escalation: VVD-130850 + Pembrolizumab Combination Therapy - 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.

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

Experimental: Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy - 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.


Treatment: Drugs: VVD-130850
Oral tablets

Treatment: Drugs: Pembrolizumab
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period
Timepoint [1] 0 0
From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]
Primary outcome [2] 0 0
Dose Expansion: Number of Participants with AEs and Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to approximately 4 years
Primary outcome [3] 0 0
Dose Expansion: Number of Participants with Clinically Significant Changes in Vital Signs
Timepoint [3] 0 0
Up to approximately 4 years
Primary outcome [4] 0 0
Dose Expansion: Number of Participants with Clinically Significant Changes in Laboratory Evaluations
Timepoint [4] 0 0
Up to approximately 4 years
Secondary outcome [1] 0 0
Dose Escalation: QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters
Timepoint [1] 0 0
Up to approximately 4 years
Secondary outcome [2] 0 0
Dose Escalation: Recommended Dose for Expansion (RDE) of VVD-130850 as a Single Agent and in Combination with Pembrolizumab
Timepoint [2] 0 0
Up to approximately 4 years
Secondary outcome [3] 0 0
Dose Expansion: Overall Response Rate (ORR)
Timepoint [3] 0 0
Up to approximately 4 years
Secondary outcome [4] 0 0
Dose Expansion: Duration of Response (DoR)
Timepoint [4] 0 0
Up to approximately 4 years
Secondary outcome [5] 0 0
Dose Expansion: Progression-free Survival (PFS)
Timepoint [5] 0 0
Up to approximately 4 years
Secondary outcome [6] 0 0
Dose Expansion: Disease Control Rate (DCR)
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [7] 0 0
Dose Escalation and Expansion: Area Under the Plasma Concentration-time Curve (AUC) of VVD-130850
Timepoint [7] 0 0
Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)
Secondary outcome [8] 0 0
Dose Escalation and Expansion: Maximum Plasma Concentration (Cmax) of VVD-130850
Timepoint [8] 0 0
Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)
Secondary outcome [9] 0 0
Dose Escalation and Expansion: Apparent Terminal Half-life (t1/2) of VVD-130850
Timepoint [9] 0 0
Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)

Eligibility
Key inclusion criteria
Key

1. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
2. Eastern Cooperative Oncology Group (ECOG) performance status =1.
3. Adequate organ and bone marrow function as defined in the protocol.
4. 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.
5. Measurable disease by RECIST version 1.1 as assessed by the Investigator.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
2. Prior allogeneic transplantation.
3. History of cardiac diseases as defined in detail in the protocol.
4. Clinically significant infection or any eye infection.
5. Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
6. 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cancer Research South Australia - Adelaide
Recruitment hospital [2] 0 0
ICON Cancer Research - South Brisbane
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Spain
State/province [6] 0 0
Barcelona
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vividion Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vividion Clinical Trial Call Center
Address 0 0
Country 0 0
Phone 0 0
(858) 345-9752
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06188208