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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05480865




Registration number
NCT05480865
Ethics application status
Date submitted
15/07/2022
Date registered
29/07/2022
Date last updated
1/02/2024

Titles & IDs
Public title
SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
Scientific title
A Phase 1 Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Combination With the KRAS-G12C Inhibitor Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
Secondary ID [1] 0 0
NAV-1003
Universal Trial Number (UTN)
Trial acronym
Argonaut
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Metastatic Solid Tumor 0 0
Metastatic NSCLC 0 0
Non Small Cell Lung Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BBP-398
Treatment: Drugs - sotorasib

Experimental: Dose Escalation: BBP-398 Level 1 and sotorasib - BBP-398 dose Level 1 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle

Experimental: Dose Escalation: BBP-398 Level 2 and sotorasib - BBP-398 dose Level 2 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle

Experimental: Dose Escalation: BBP-398 Level 3 and sotorasib - BBP-398 dose Level 3 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle

Experimental: Dose Expansion/Optimization: BBP-398 Dose Regimen 1 and sotorasib - BBP-398 Dose Regimen 1 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle

Experimental: Dose Expansion/Optimization: BBP-398 Dose Regimen 2 and sotorasib - BBP-398 Dose Regimen 2 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle


Treatment: Drugs: BBP-398
BBP-398 administered orally

Treatment: Drugs: sotorasib
sotorasib administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a Dose Escalation Primary Objective: Incidence and Severity of Treatment-Emergent Adverse Events, Serious Adverse Events, and Dose Limiting Toxicities
Timepoint [1] 0 0
Completion of 1 Cycle (28 days)
Primary outcome [2] 0 0
Phase 1b Dose Expansion/Optimization Primary Objective: Incidence and Severity of Treatment-Emergent Adverse Events, and Serious Adverse Events
Timepoint [2] 0 0
Completion of 1 Cycle (28 days)
Primary outcome [3] 0 0
Phase 1b Dose Expansion/Optimization Primary Objective: Overall Response Rate (ORR)
Timepoint [3] 0 0
8 weeks
Secondary outcome [1] 0 0
Phase 1a Dose Escalation Secondary Objectives: Overall Response Rate (ORR)
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Duration of response
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Maximum Observed Plasma Concentration (Cmax) of BBP-398
Timepoint [5] 0 0
Cycle 2 Day 1
Secondary outcome [6] 0 0
Time to Cmax (Tmax) of BBP-398
Timepoint [6] 0 0
Cycle 2 Day 1
Secondary outcome [7] 0 0
Area under the plasma concentration-time curve (AUC) of BBP-398
Timepoint [7] 0 0
Cycle 2 Day 1
Secondary outcome [8] 0 0
Half-life (T1/2) of BBP-398
Timepoint [8] 0 0
Cycle 2 Day 1
Secondary outcome [9] 0 0
Observed Maximum Plasma Concentration (Cmax) of sotorasib
Timepoint [9] 0 0
Cycle 2 Day 1
Secondary outcome [10] 0 0
Time to Cmax (Tmax) of sotorasib
Timepoint [10] 0 0
Cycle 2 Day 1
Secondary outcome [11] 0 0
Area under the plasma concentration-time curve (AUC) over dosing interval of sotorasib
Timepoint [11] 0 0
Cycle 2 Day 1
Secondary outcome [12] 0 0
Half-life (T1/2) of sotorasib
Timepoint [12] 0 0
Cycle 2 Day 1
Secondary outcome [13] 0 0
Circulating and intratumoral target engagement biomarkers of BBP-398 activity in combination with sotorasib
Timepoint [13] 0 0
24 months

Eligibility
Key inclusion criteria
Key

- Patients must have histologically documented, locally advanced and unresectable, or
metastatic solid tumor with documentation of a KRAS-G12C mutation within 2 years prior
to screening.

- Patients must have measurable disease by RECIST v1.1.

- Patients must have a minimum life expectancy of >12 weeks after start of study
treatment.

- Patients must have progression or disease recurrence on or after all available
standard of care therapies.

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status
(PS) 0-1.

- Patients must have adequate organ function.

Key
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients that have participated in an interventional clinical study within the last 4
weeks.

- Patients that have received radiotherapy or proton therapy with a limited field of
radiation for palliation within 1 week of the start of study treatment, OR radiation
to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks
of the start of study treatment.

- Patients with untreated and/or active CNS metastases.

- Patients that have a history of allogenic bone marrow transplant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
6/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [2] 0 0
Southern Oncology Clinical Research Unit - Adelaide
Recruitment hospital [3] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [4] 0 0
One Clinical Research - Perth
Recruitment hospital [5] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment hospital [6] 0 0
Orange Health Service - Orange
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment postcode(s) [6] 0 0
NSW 2800 - Orange
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen
Country [2] 0 0
France
State/province [2] 0 0
Bordeaux
Country [3] 0 0
France
State/province [3] 0 0
Dijon
Country [4] 0 0
France
State/province [4] 0 0
Grenoble
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
France
State/province [6] 0 0
Rennes
Country [7] 0 0
Greece
State/province [7] 0 0
Thessaloníki
Country [8] 0 0
Italy
State/province [8] 0 0
Largo Brambilla
Country [9] 0 0
Italy
State/province [9] 0 0
Brescia
Country [10] 0 0
Italy
State/province [10] 0 0
Napoli
Country [11] 0 0
Netherlands
State/province [11] 0 0
Amsterdam
Country [12] 0 0
Netherlands
State/province [12] 0 0
Rotterdam
Country [13] 0 0
Spain
State/province [13] 0 0
Barcelona
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid
Country [15] 0 0
Spain
State/province [15] 0 0
Málaga
Country [16] 0 0
Spain
State/province [16] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Navire Pharma Inc., a BridgeBio company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with sotorasib, a
KRAS-G12C inhibitor (KRAS-G12Ci), in patients with a KRAS-G12C mutation.

The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose
Expansion/Optimization.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05480865
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
Navire Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
650-391-9740
Fax 0 0
Email 0 0
NAV1003ct.gov@bridgebio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05480865