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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06659341




Registration number
NCT06659341
Ethics application status
Date submitted
15/10/2024
Date registered
26/10/2024

Titles & IDs
Public title
A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation
Scientific title
Phase 1 Study of a SOS1 Inhibitor, BAY 3498264, in Combination in Participants With Advanced KRASG12C-mutated Solid Tumors
Secondary ID [1] 0 0
2024-513300-34-00
Secondary ID [2] 0 0
22676
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors Harboring KRAS G12C Mutation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY3498264

Experimental: Dose escalation - During dose escalation, at each dose level BAY3498264 monotherapy will be administered for 7 days as a safety run-in, prior to introduction of a combination agent (sotorasib) for 21-day treatment cycles. Intra-participant dose escalation will be implemented: participants will be able to move to a cohort offering a higher dose level of BAY3498264 provided protocol-specified criteria are met.

Experimental: Backfill cohorts - Backfill cohorts may be initiated concurrently with dose escalation cohorts to generate additional safety, PK, and PD data to facilitate the selection of the optimal doses for use in further development.

Experimental: Exploratory expansion cohorts - Exploratory expansion cohorts may be recruited to provide additional safety, PK/PD, and efficacy data.


Treatment: Drugs: BAY3498264
Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) categorized by severity.
Timepoint [1] 0 0
30-35 days after the last dose
Primary outcome [2] 0 0
Maximum tolerated dose (MTD) or Maximum administered dose (MAD) of BAY 3498264 in combination with sotorasib.
Timepoint [2] 0 0
Approximate 3 years
Primary outcome [3] 0 0
Number of participants with Dose-limiting toxicity (DLTs) during the DLT observation period categorized by severity.
Timepoint [3] 0 0
DLT evaluation period (Cycle 1) includes 28 days
Primary outcome [4] 0 0
Maximum observed drug concentration in plasma (Cmax) of the respective dosing interval of BAY3498264 after single dose and multiple dose administrations.
Timepoint [4] 0 0
Multiple time points: Cycle 1 28-day cycle followed by 21-day treatment cycles
Primary outcome [5] 0 0
Area under the concentration vs. time curve (AUC) of the respective dosing interval of BAY3498264 after single dose and multiple dose administrations.
Timepoint [5] 0 0
Multiple time points: Cycle 1 28-day cycle followed by 21-day treatment cycles
Secondary outcome [1] 0 0
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by investigator assessment.
Timepoint [1] 0 0
Every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (± 7 days) thereafter until radiological disease progression (PD) occurs
Secondary outcome [2] 0 0
Recommended dose(s) and schedule(s) of BAY 3498264 to be used in combination with sotorasib for further development stages.
Timepoint [2] 0 0
Approximate 3 years

Eligibility
Key inclusion criteria
* Histologically confirmed solid tumor malignancy with documented KRASG12C mutation as assessed by an appropriately accredited laboratory.
* Documented disease progression after treatment with at least 1 prior standard of care (SoC) systemic therapy other than a G12C inhibitor for locally advanced or metastatic disease, and with no further standard treatment options available, or when standard treatment options are not acceptable and this study is a reasonable option.

* Participants whose access to SoC therapies is limited due to regional access, refusal, intolerance, or eligibility may participate.
* Prior G12C inhibitor treatment is permitted. Participants receiving prior G12C inhibitor therapy must have documented disease progression after treatment, or have discontinued that treatment due to intolerance.
* Adequate archival formalin-fixed paraffin-embedded tumor tissue available (preferably no older than 6 months, obtained after the last targeted therapy). If archival material is not available, a fresh tumor biopsy should ideally be obtained if safe and feasible.
* Eastern Cooperative Oncology Group (ECOG) of 0 to 2 and life expectancy of at least 12 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active central nervous system (CNS) tumors including metastatic brain disease, at the time of screening.

1. 'Active' is defined as untreated brain lesions (new or progressing) or symptomatic brain lesions (as determined by the investigator)
2. Participants who have received treatment (e.g. surgery or radiotherapy) for brain metastases ending at least 4 weeks before cycle 1 day 1 (C1D1) may be eligible if, at the point of study entry:

i. their condition is considered stable by the investigator ii. they have no residual neurological symptoms (Grade >2) iii. a follow-up Magnetic resonance imaging (MRI) scan during the screening period shows no progression or new lesions iv. they do not need systemic corticosteroids to treat symptoms of brain metastasis
* Any grade active pneumonitis or interstitial lung disease (ILD), or past medical history of:

1. Grade =2 ILD,
2. Drug-induced ILD
3. Radiation pneumonitis that required steroid treatment within the last 12 months
* Additional malignancy within the past 3 years, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, in agreement with the Sponsor, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.
* Any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating the presence of virus.

* Active HBV (chronic or acute; defined as having a known positive HBsAg test at the time of screening) except for participants on antiviral therapy for HBV with an undetectable or low viral load.
* Participants with past HBV infection or resolved HBV infection (defined as the presence of HBcAb and absence of HBsAg) are eligible if HBV DNA is negative.
* Participants positive for HCV antibody unless polymerase chain reaction is negative for HCV RNA. Any prior antiviral therapy must be completed at least 28 days before the first dose of study intervention.

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
8/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/11/2027
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Peninsula and Southeast Oncology - Frankston
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen OE
Country [2] 0 0
Italy
State/province [2] 0 0
Lazio
Country [3] 0 0
Italy
State/province [3] 0 0
Rozzano
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Surrey
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
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
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
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
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


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/NCT06659341