Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06804824
Registration number
NCT06804824
Ethics application status
Date submitted
27/01/2025
Date registered
3/02/2025
Date last updated
18/06/2025
Titles & IDs
Public title
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors
Query!
Scientific title
A Phase 1/1b, Open-Label, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-159642, a RAS-PI3Ka Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors
Query!
Secondary ID [1]
0
0
VVD-159642-01
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - VVD-159642
Treatment: Drugs - Sotorasib
Treatment: Drugs - Trametinib
Experimental: Part 1: Dose Escalation: VVD-159642 Single Agent - Participants will receive ascending doses of VVD-159642, orally, daily in 21-day treatment cycles during Part 1.
Experimental: Part 2: Dose Expansion (Cohort A): VVD-159642 Single Agent - Participants will receive VVD-159642 at the recommended dose for expansion (RDE), orally, daily in 21-day treatment cycles during Part 2.
Experimental: Part 2: Dose Expansion (Cohort B): VVD-159642 + Sotorasib - Participants will receive VVD-159642 at RDE orally, daily in combination with sotorasib, in 21-day treatment cycles after a safety run-in.
Experimental: Part 2: Dose Expansion (Cohort C): VVD-159642 + Trametinib - Participants will receive VVD-159642 at RDE orally, daily in combination with trametinib, in 21-day treatment cycles after a safety run-in.
Treatment: Drugs: VVD-159642
Oral capsules
Treatment: Drugs: Sotorasib
Oral tablets
Treatment: Drugs: Trametinib
Oral tablets
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]
Query!
Primary outcome [2]
0
0
Part 2: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to approximately 29 months
Query!
Primary outcome [3]
0
0
Part 2: Incidence and Severity of Clinically Significant Changes in Vital Signs
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Up to approximately 29 months
Query!
Primary outcome [4]
0
0
Part 2: Incidence and Severity of Clinically Significant Changes in Laboratory Evaluations
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Up to approximately 29 months
Query!
Secondary outcome [1]
0
0
Part 1: Recommended Dose for Expansion (RDE) of VVD-159642 as a Single Agent
Query!
Assessment method [1]
0
0
The RDE will be based on safety, tolerability, PK, and preliminary anti-tumor activity of VVD-159642 as a single agent during the dose escalation phase.
Query!
Timepoint [1]
0
0
Up to approximately 29 months
Query!
Secondary outcome [2]
0
0
Part 2: Recommended Phase 2 Dose (RP2D) of VVD-159642 as a Single Agent and in Combination with Sotorasib and Trametinib
Query!
Assessment method [2]
0
0
The RP2D will be based on safety, tolerability, PK and preliminary anti-tumor activity of VVD-159642 as single agent, and in combination with sotorasib and trametinib during Part 2.
Query!
Timepoint [2]
0
0
Up to approximately 29 months
Query!
Secondary outcome [3]
0
0
Part 2: Overall Response Rate (ORR)
Query!
Assessment method [3]
0
0
ORR is defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.
Query!
Timepoint [3]
0
0
Up to approximately 29 months
Query!
Secondary outcome [4]
0
0
Part 2: Duration of Response (DoR)
Query!
Assessment method [4]
0
0
DOR is defined as the time from initial response of CR or PR to progressive disease or death, whichever comes first per RECIST version 1.1 by investigator assessment.
Query!
Timepoint [4]
0
0
Up to approximately 29 months
Query!
Secondary outcome [5]
0
0
Part 2: Progression-free Survival (PFS)
Query!
Assessment method [5]
0
0
PFS is defined as the time from the date of randomization to the time of confirmed disease progression or death, whichever occurs first per RECIST version 1.1 by investigator assessment.
Query!
Timepoint [5]
0
0
Up to approximately 29 months
Query!
Secondary outcome [6]
0
0
Part 2: Disease Control Rate (DCR)
Query!
Assessment method [6]
0
0
DCR is defined as the percentage of participants achieving CR or PR, or stable disease (SD) per RECIST version 1.1 by investigator assessment.
Query!
Timepoint [6]
0
0
Up to approximately 29 months
Query!
Secondary outcome [7]
0
0
Parts 1 and 2: Area Under the Plasma Concentration-time Curve (AUC) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib
Query!
Assessment method [7]
0
0
Query!
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)
Query!
Secondary outcome [8]
0
0
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib
Query!
Assessment method [8]
0
0
Query!
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)
Query!
Secondary outcome [9]
0
0
Parts 1 and 2: Half-life (t1/2) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib
Query!
Assessment method [9]
0
0
Query!
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)
Query!
Eligibility
Key inclusion criteria
Key
* For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration [Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)] as per local /historical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local/historical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry [IHC] 3+ or IHC 2+/fluorescence in situ hybridization [FISH] positive) as per local/historical testing.
* Have histologically or cytologically confirmed metastatic or unresectable solid tumors.
* Measurable disease by RECIST version 1.1 as assessed by the investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status =1.
* Adequate bone marrow, kidney, and liver function as defined in the protocol.
* Able to take oral medications.
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Active central nervous system (CNS) malignancies.
* History of cardiac diseases as defined in detail in the protocol.
* Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
* History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study.
* Active hepatitis B infection [positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)].
* Active hepatitis C infection (positive anti-hepatitis C virus [HCV] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/02/2025
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/08/2027
Query!
Actual
Query!
Sample size
Target
220
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
SA,WA
Query!
Recruitment hospital [1]
0
0
Clinical Research South Australia (CRSA) - Adelaide
Query!
Recruitment hospital [2]
0
0
Linear Clinical - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Michigan
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Texas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Utah
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Virginia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Vividion Therapeutics, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Ka) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06804824
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Vividion Clinical Trial Call Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
858-345-9752
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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/NCT06804824
Download to PDF