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Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (KontRASt-01)

Primary Purpose

KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JDQ443
TNO155
tislelizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for KRAS G12C Mutant Solid Tumors focused on measuring KRAS, KRAS G12C, Metastatic cancer, Advanced cancer, Enzyme inhibitor, PD-1, SHP2, Targeted therapy, Non-small-cell lung cancer, colorectal cancer, Molecular mechanisms of pharmacological action

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
  • 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.

Sites / Locations

  • Emory University School of Medicine/Winship Cancer Institute G2304 - C2301Recruiting
  • Massachusetts General Hospital Cancer CenterRecruiting
  • Washington University School .
  • Providence Cancer CenterRecruiting
  • Hillman Cancer CenterRecruiting
  • Uni of TX MD Anderson Cancer Cntr Dept of MD Anderson CancerCentRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm D

Arm Description

JDQ443

JDQ443 in combination with TNO155

JDQ443 in combination with tislelizumab

JDQ443 in combination with TNO155 and tislelizumab

Outcomes

Primary Outcome Measures

Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment
Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs).
Dose Escalation: Frequency of dose interruptions and reductions, by treatment
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions.
Dose Escalation: Dose intensity by treatment
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of treatment.
Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment
Overall response rate is defined as the proportion of patients with a BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI). Applies to all groups except the brain metastasis group.
Dose expansion: Overall intracranial response rate (OIRR) per mRANO-BM
OIRR per mRANO-BM is defined as the proportion of participants with a best overall intracranial response (BOIR) of CR or PR according to mRANO-BM criteria, and will be summarized along with the corresponding 90% and 95% exact CI. Applies to brain metastasis group only.
Dose expansion: Incidence and severity of AEs and SAEs
All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs). Applies to JDQ443 dose randomization group only.
Dose expansion: frequency of dose interruptions and reductions, by treatment
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions. Applies to JDQ443 dose randomization group only.
Dose expansion: Dose intensity by treatment
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of treatment. Applies to JDQ443 dose randomization group only
Dose expansion: ORR per RECIST 1.1 of JDQ443 single agent in patients with non-small cell lung cancer (JDQ443 dose randomization group only)
Overall response rate is defined as the proportion of patients with BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI). Applies to JDQ443 dose randomization group only

Secondary Outcome Measures

Dose Escalation and Expansion: ORR per RECIST v1.1
Overall response rate is defined as the proportion of patients with a BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI)
Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1
BOR is defined as the best overall confirmed response recorded from the start of the treatment until disease progression/recurrence.
Dose Escalation and Expansion: Progression-free survival (PFS) per RECIST v1.1, Overall Survival (OS)
Per RECIST 1.1, PFS is defined as the time from the date of start of treatment to the date of the first documented progression, or death. If patient has not had an event, PFS will be censored at the date of last adequate tumor assessment. PFS will be summarized using the Kaplan-Meier method, along with 95% CI
Dose Escalation and Expansion: Duration of Response (DOR) per RECIST v1.1
Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due any cause. Estimates will use Kaplan-Meier method, and median DOR and corresponding 95% CI will be presented.
Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1
The disease control rate is calculated as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease. It will be summarized along with the corresponding 95% exact CI
Dose Escalation and Expansion: Plasma or serum concentration vs time profiles (AUC) by treatment
AUC is defined as area under the plasma or serum concentration versus time curve after a dose of JDQ443, TNO155 and tislelizumab
Dose Escalation and Expansion: Plasma concentration (Cmax) by treatment
Cmax is defined as the maximum observed plasma or serum drug concentration after single dose administration.
Dose Escalation and Expansion: Time to achieve Cmax (Tmax) by treatment
Tmax is defined as the time to reach maximum plasma or serum drug concentration after single dose administration.
Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment
To evaluate the immunogenicity of tislelizumab when dosed in combination with JDQ443 and/or TNO155 - only applicable to Arms C and D
Dose Expansion: Dose intensity by treatment
Dose Expansion: Frequency of dose interruptions and reductions, by treatment
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions.
Dose Expansion: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment
Dose Expansion: Incidence and severity of AEs and SAEs by treatment
Dose expansion: Intracranial disease control rate (IDCR) per mRANO-BM
IDCR is the proportion of participants with a confirmed BOIR of CR or PR or SD (or non-CR/non-PD) per mRANO-BM criteria. It will be summarized along with the corresponding 90% and 95% CI. Applies to the brain metastasis group only.
Dose expansion: Best overall intracranial response (BOIR) per mRANO-BM
BOIR is defined as the best overall confirmed response recorded from the start of the treatment until disease progression/recurrence per mRANO-BM, or until patient comes off study, whichever comes first. BOIR will be summarized along with the corresponding 95% exact CI. Applies to the brain metastasis group only.
Dose expansion: Intracranial progression free survival (IPFS) per mRANO-BM
IPFS is defined as the time from the date of start of treatment to the date of the first documented progression per mRANO-BM, or death due to any cause. If a patient has not had an event, IPFS will be censored at the date of last adequate tumor assessment. IPFS will be summarized using the Kaplan-Meier method. Median IPFS and IPFS probability at pre specified time-points will be presented along with 95% CI. Applies to the brain metastasis group only.
Dose expansion: Duration of intracranial response (DOIR) per mRANO-BM
DOIR is defined as the time from the date of first documented intracranial response of either CR or PR to the date of the first documented intracranial progression as per mRANO-BM criteria as assessed by central review or date of death due to underlying cause of cancer. DOIR will be summarized using the KM method if data permit. Median DOIR, with corresponding 95% CI. KM estimates for DOIR proportions at specific time points, along with 95% CI will also be provided. Applies to the brain metastasis group only.

Full Information

First Posted
January 5, 2021
Last Updated
October 5, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04699188
Brief Title
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Acronym
KontRASt-01
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
January 8, 2027 (Anticipated)
Study Completion Date
January 8, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms
Keywords
KRAS, KRAS G12C, Metastatic cancer, Advanced cancer, Enzyme inhibitor, PD-1, SHP2, Targeted therapy, Non-small-cell lung cancer, colorectal cancer, Molecular mechanisms of pharmacological action

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
475 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
JDQ443
Arm Title
Arm B
Arm Type
Experimental
Arm Description
JDQ443 in combination with TNO155
Arm Title
Arm C
Arm Type
Experimental
Arm Description
JDQ443 in combination with tislelizumab
Arm Title
Arm D
Arm Type
Experimental
Arm Description
JDQ443 in combination with TNO155 and tislelizumab
Intervention Type
Drug
Intervention Name(s)
JDQ443
Intervention Description
KRAS G12C inhibitor
Intervention Type
Drug
Intervention Name(s)
TNO155
Intervention Description
SHP2 inhibitor
Intervention Type
Biological
Intervention Name(s)
tislelizumab
Intervention Description
Anti PD1 antibody
Primary Outcome Measure Information:
Title
Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
Description
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment
Time Frame
21 days
Title
Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Description
All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs).
Time Frame
24 months
Title
Dose Escalation: Frequency of dose interruptions and reductions, by treatment
Description
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions.
Time Frame
24 months
Title
Dose Escalation: Dose intensity by treatment
Description
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of treatment.
Time Frame
24 months
Title
Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment
Description
Overall response rate is defined as the proportion of patients with a BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI). Applies to all groups except the brain metastasis group.
Time Frame
24 months
Title
Dose expansion: Overall intracranial response rate (OIRR) per mRANO-BM
Description
OIRR per mRANO-BM is defined as the proportion of participants with a best overall intracranial response (BOIR) of CR or PR according to mRANO-BM criteria, and will be summarized along with the corresponding 90% and 95% exact CI. Applies to brain metastasis group only.
Time Frame
24 months
Title
Dose expansion: Incidence and severity of AEs and SAEs
Description
All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs). Applies to JDQ443 dose randomization group only.
Time Frame
24 months
Title
Dose expansion: frequency of dose interruptions and reductions, by treatment
Description
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions. Applies to JDQ443 dose randomization group only.
Time Frame
24 months
Title
Dose expansion: Dose intensity by treatment
Description
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of treatment. Applies to JDQ443 dose randomization group only
Time Frame
24 months
Title
Dose expansion: ORR per RECIST 1.1 of JDQ443 single agent in patients with non-small cell lung cancer (JDQ443 dose randomization group only)
Description
Overall response rate is defined as the proportion of patients with BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI). Applies to JDQ443 dose randomization group only
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Dose Escalation and Expansion: ORR per RECIST v1.1
Description
Overall response rate is defined as the proportion of patients with a BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI)
Time Frame
24 months
Title
Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1
Description
BOR is defined as the best overall confirmed response recorded from the start of the treatment until disease progression/recurrence.
Time Frame
24 months
Title
Dose Escalation and Expansion: Progression-free survival (PFS) per RECIST v1.1, Overall Survival (OS)
Description
Per RECIST 1.1, PFS is defined as the time from the date of start of treatment to the date of the first documented progression, or death. If patient has not had an event, PFS will be censored at the date of last adequate tumor assessment. PFS will be summarized using the Kaplan-Meier method, along with 95% CI
Time Frame
24 months
Title
Dose Escalation and Expansion: Duration of Response (DOR) per RECIST v1.1
Description
Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due any cause. Estimates will use Kaplan-Meier method, and median DOR and corresponding 95% CI will be presented.
Time Frame
24 months
Title
Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1
Description
The disease control rate is calculated as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease. It will be summarized along with the corresponding 95% exact CI
Time Frame
24 months
Title
Dose Escalation and Expansion: Plasma or serum concentration vs time profiles (AUC) by treatment
Description
AUC is defined as area under the plasma or serum concentration versus time curve after a dose of JDQ443, TNO155 and tislelizumab
Time Frame
Up to 24 months
Title
Dose Escalation and Expansion: Plasma concentration (Cmax) by treatment
Description
Cmax is defined as the maximum observed plasma or serum drug concentration after single dose administration.
Time Frame
Up to 24 months
Title
Dose Escalation and Expansion: Time to achieve Cmax (Tmax) by treatment
Description
Tmax is defined as the time to reach maximum plasma or serum drug concentration after single dose administration.
Time Frame
Up to 24 months
Title
Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment
Description
To evaluate the immunogenicity of tislelizumab when dosed in combination with JDQ443 and/or TNO155 - only applicable to Arms C and D
Time Frame
Up to 24 months
Title
Dose Expansion: Dose intensity by treatment
Time Frame
24 months
Title
Dose Expansion: Frequency of dose interruptions and reductions, by treatment
Description
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions.
Time Frame
24 months
Title
Dose Expansion: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
Description
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment
Time Frame
21 days
Title
Dose Expansion: Incidence and severity of AEs and SAEs by treatment
Time Frame
24 months
Title
Dose expansion: Intracranial disease control rate (IDCR) per mRANO-BM
Description
IDCR is the proportion of participants with a confirmed BOIR of CR or PR or SD (or non-CR/non-PD) per mRANO-BM criteria. It will be summarized along with the corresponding 90% and 95% CI. Applies to the brain metastasis group only.
Time Frame
24 months
Title
Dose expansion: Best overall intracranial response (BOIR) per mRANO-BM
Description
BOIR is defined as the best overall confirmed response recorded from the start of the treatment until disease progression/recurrence per mRANO-BM, or until patient comes off study, whichever comes first. BOIR will be summarized along with the corresponding 95% exact CI. Applies to the brain metastasis group only.
Time Frame
24 months
Title
Dose expansion: Intracranial progression free survival (IPFS) per mRANO-BM
Description
IPFS is defined as the time from the date of start of treatment to the date of the first documented progression per mRANO-BM, or death due to any cause. If a patient has not had an event, IPFS will be censored at the date of last adequate tumor assessment. IPFS will be summarized using the Kaplan-Meier method. Median IPFS and IPFS probability at pre specified time-points will be presented along with 95% CI. Applies to the brain metastasis group only.
Time Frame
24 months
Title
Dose expansion: Duration of intracranial response (DOIR) per mRANO-BM
Description
DOIR is defined as the time from the date of first documented intracranial response of either CR or PR to the date of the first documented intracranial progression as per mRANO-BM criteria as assessed by central review or date of death due to underlying cause of cancer. DOIR will be summarized using the KM method if data permit. Median DOIR, with corresponding 95% CI. KM estimates for DOIR proportions at specific time points, along with 95% CI will also be provided. Applies to the brain metastasis group only.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Facility Information:
Facility Name
Emory University School of Medicine/Winship Cancer Institute G2304 - C2301
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Obi Okafor
Phone
404-727-3189
Email
aookafo@emory.edu
First Name & Middle Initial & Last Name & Degree
Conor E. Steuer
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Heist
Email
rheist@partners.org
First Name & Middle Initial & Last Name & Degree
Rebecca Heist
Facility Name
Washington University School .
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Withdrawn
Facility Name
Providence Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Song
Phone
503-215-2691
Email
teresa.song@providence.org
First Name & Middle Initial & Last Name & Degree
Rachel Sanborn
Facility Name
Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Sellitto
Phone
412-647-8569
Email
sellittol@upmc.edu
First Name & Middle Initial & Last Name & Degree
Taofeek K Owonikoko
Facility Name
Uni of TX MD Anderson Cancer Cntr Dept of MD Anderson CancerCent
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Okumah
Phone
+1 713 745 3039
Email
rokumah@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Marcelo Vailati Negrao
Facility Name
Novartis Investigative Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
51000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466 8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277 8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chuo ku
State/Province
Tokyo
ZIP/Postal Code
104 0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koto ku
State/Province
Tokyo
ZIP/Postal Code
135 8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hospitalet de LLobregat
State/Province
Catalunya
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Citations:
PubMed Identifier
36399068
Citation
Lorthiois E, Gerspacher M, Beyer KS, Vaupel A, Leblanc C, Stringer R, Weiss A, Wilcken R, Guthy DA, Lingel A, Bomio-Confaglia C, Machauer R, Rigollier P, Ottl J, Arz D, Bernet P, Desjonqueres G, Dussauge S, Kazic-Legueux M, Lozac'h MA, Mura C, Sorge M, Todorov M, Warin N, Zink F, Voshol H, Zecri FJ, Sedrani RC, Ostermann N, Brachmann SM, Cotesta S. JDQ443, a Structurally Novel, Pyrazole-Based, Covalent Inhibitor of KRASG12C for the Treatment of Solid Tumors. J Med Chem. 2022 Dec 22;65(24):16173-16203. doi: 10.1021/acs.jmedchem.2c01438. Epub 2022 Nov 18.
Results Reference
derived

Learn more about this trial

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

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