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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04699188




Registration number
NCT04699188
Ethics application status
Date submitted
5/01/2021
Date registered
7/01/2021

Titles & IDs
Public title
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Scientific title
A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Secondary ID [1] 0 0
2020-004129-22
Secondary ID [2] 0 0
CJDQ443A12101
Universal Trial Number (UTN)
Trial acronym
KontRASt-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
KRAS G12C Mutant Solid Tumors 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Carcinoma, Colorectal 0 0
Cancer of Lung 0 0
Cancer of the Lung 0 0
Lung Cancer 0 0
Neoplasms, Lung 0 0
Neoplasms, Pulmonary 0 0
Pulmonary Cancer 0 0
Pulmonary Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JDQ443
Treatment: Drugs - TNO155
Treatment: Other - tislelizumab

Experimental: Arm A - JDQ443

Experimental: Arm B - JDQ443 in combination with TNO155

Experimental: Arm C - JDQ443 in combination with tislelizumab

Experimental: Arm D - JDQ443 in combination with TNO155 and tislelizumab


Treatment: Drugs: JDQ443
KRAS G12C inhibitor

Treatment: Drugs: TNO155
SHP2 inhibitor

Treatment: Other: tislelizumab
Anti PD1 antibody
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
Timepoint [1] 0 0
21 days
Primary outcome [2] 0 0
Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Dose Escalation: Frequency of dose interruptions and reductions, by treatment
Timepoint [3] 0 0
24 months
Primary outcome [4] 0 0
Dose Escalation: Dose intensity by treatment
Timepoint [4] 0 0
24 months
Primary outcome [5] 0 0
Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment
Timepoint [5] 0 0
24 months
Primary outcome [6] 0 0
Dose expansion: Overall intracranial response rate (OIRR) per mRANO-BM
Timepoint [6] 0 0
24 months
Primary outcome [7] 0 0
Dose expansion: Incidence and severity of AEs and SAEs
Timepoint [7] 0 0
24 months
Primary outcome [8] 0 0
Dose expansion: frequency of dose interruptions and reductions, by treatment
Timepoint [8] 0 0
24 months
Primary outcome [9] 0 0
Dose expansion: Dose intensity by treatment
Timepoint [9] 0 0
24 months
Primary outcome [10] 0 0
Dose expansion: ORR per RECIST 1.1 of JDQ443 single agent in patients with non-small cell lung cancer (JDQ443 dose randomization group only)
Timepoint [10] 0 0
24 months
Secondary outcome [1] 0 0
Dose Escalation and Expansion: ORR per RECIST v1.1
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Dose Escalation and Expansion: Progression-free survival (PFS) per RECIST v1.1, Overall Survival (OS)
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Dose Escalation and Expansion: Duration of Response (DOR) per RECIST v1.1
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Dose Escalation and Expansion: Plasma or serum concentration vs time profiles (AUC) by treatment
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Dose Escalation and Expansion: Plasma concentration (Cmax) by treatment
Timepoint [7] 0 0
Up to 24 months
Secondary outcome [8] 0 0
Dose Escalation and Expansion: Time to achieve Cmax (Tmax) by treatment
Timepoint [8] 0 0
Up to 24 months
Secondary outcome [9] 0 0
Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment
Timepoint [9] 0 0
Up to 24 months
Secondary outcome [10] 0 0
Dose Expansion: Dose intensity by treatment
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Dose Expansion: Frequency of dose interruptions and reductions, by treatment
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
Dose Expansion: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
Timepoint [12] 0 0
21 days
Secondary outcome [13] 0 0
Dose Expansion: Incidence and severity of AEs and SAEs by treatment
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Dose expansion: Intracranial disease control rate (IDCR) per mRANO-BM
Timepoint [14] 0 0
24 months
Secondary outcome [15] 0 0
Dose expansion: Best overall intracranial response (BOIR) per mRANO-BM
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
Dose expansion: Intracranial progression free survival (IPFS) per mRANO-BM
Timepoint [16] 0 0
24 months
Secondary outcome [17] 0 0
Dose expansion: Duration of intracranial response (DOIR) per mRANO-BM
Timepoint [17] 0 0
24 months

Eligibility
Key inclusion criteria
* Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies
* ECOG Performance Status of 0 or 1
* At least one measurable lesion as defined by RECIST 1.1
* Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
* Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible
* Clinically significant cardiac disease or risk factors at screening
* A medical condition that results in increased photosensitivity Other protocol-defined inclusion/exclusion criteria may apply.

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/08/2025
Actual
Sample size
Target
Accrual to date
Final
344
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
China
State/province [8] 0 0
Fujian
Country [9] 0 0
China
State/province [9] 0 0
Guangdong
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
Denmark
State/province [11] 0 0
Copenhagen
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Villejuif
Country [15] 0 0
Germany
State/province [15] 0 0
Dresden
Country [16] 0 0
Germany
State/province [16] 0 0
Essen
Country [17] 0 0
Germany
State/province [17] 0 0
Freiburg
Country [18] 0 0
Germany
State/province [18] 0 0
Koeln
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Hong Kong
Country [20] 0 0
Italy
State/province [20] 0 0
BS
Country [21] 0 0
Italy
State/province [21] 0 0
MI
Country [22] 0 0
Japan
State/province [22] 0 0
Aichi
Country [23] 0 0
Japan
State/province [23] 0 0
Chiba
Country [24] 0 0
Japan
State/province [24] 0 0
Osaka
Country [25] 0 0
Japan
State/province [25] 0 0
Tokyo
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Singapore
State/province [27] 0 0
Singapore
Country [28] 0 0
Spain
State/province [28] 0 0
Andalucia
Country [29] 0 0
Spain
State/province [29] 0 0
Catalunya
Country [30] 0 0
Spain
State/province [30] 0 0
Comunidad Valenciana
Country [31] 0 0
Spain
State/province [31] 0 0
Galicia
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Taiwan
State/province [33] 0 0
Tainan
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
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
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04699188