Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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