KRAS G12C Mutant Solid TumorsPhase 1/2KontRASt-01NCT04699188
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
A Phase 1/2 study testing JDQ443, TNO155 and tislelizumab in people with KRAS G12C Mutant Solid Tumors and Carcinoma, Non-Small-Cell Lung, run by Novartis Pharmaceuticals at 38 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal
- What is being tested?
- JDQ443, TNO155 and tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 38 sitesin 16 countries
- Study dates
- 24 Feb 2021to 25 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
38 sites in 16 countries.
38 sites in 16 countries
Spain6 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Madrid, 28050
Novartis Investigative Site
Málaga, 29010
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
Novartis Investigative Site
Valencia, 46010
United States5 sites
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, 30322
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Japan5 sites
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045
Novartis Investigative Site
Kashiwa, Chiba, 2778577
Novartis Investigative Site
Koto Ku, Tokyo, 1358550
Novartis Investigative Site
Nagoya, Aichi-ken, 4668560
Novartis Investigative Site
Osaka, Osaka, 5418567
Germany4 sites
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
France3 sites
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Marseille, 13273
Novartis Investigative Site
Villejuif, 94800
Italy3 sites
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20162
China2 sites
Novartis Investigative Site
Beijing, 100036
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Singapore2 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 168583
About this study
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
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.
- Conditions
- KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung, Cancer of the Lung, Lung Cancer
- Being tested
- JDQ443, TNO155, tislelizumab
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JDQ443Drug
KRAS G12C inhibitor
TNO155Drug
SHP2 inhibitor
tislelizumabBiological
Anti PD1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | JDQ443 Receives: Drug: JDQ443 |
| Arm B | Experimental | JDQ443 in combination with TNO155 Receives: Drug: JDQ443; Drug: TNO155 |
| Arm C | Experimental | JDQ443 in combination with tislelizumab Receives: Drug: JDQ443; Biological: tislelizumab |
| Arm D | Experimental | JDQ443 in combination with TNO155 and tislelizumab Receives: Drug: JDQ443; Drug: TNO155; Biological: tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
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).
Measured: 24 months
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.
Measured: 24 months
Dose Escalation: Dose intensity by treatment
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of treatment.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
Secondary outcomes (17)
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)
Measured: 24 months
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.
Measured: 24 months
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
Measured: 24 months
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.
Measured: 24 months
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
Measured: 24 months
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
Measured: Up to 24 months
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.
Measured: Up to 24 months
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.
Measured: Up to 24 months
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
Measured: Up to 24 months
Dose Expansion: Dose intensity by treatment
Measured: 24 months
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.
Measured: 24 months
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
Measured: 21 days
Dose Expansion: Incidence and severity of AEs and SAEs by treatment
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start24 Feb 2021
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KRAS G12C Mutant Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699188
- Sponsor's protocol ID
- CJDQ443A12101
- Other IDs
- 2020-004129-22
- Acronym
- KontRASt-01
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 36399068
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04699188
- Acronym / sponsor ID
- KontRASt-01 / CJDQ443A12101
- Conditions
- KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung, Cancer of the Lung, Lung Cancer
- Keywords
- KRAS, KRAS G12C, Metastatic cancer, Advanced cancer, Enzyme inhibitor, PD-1, SHP2, Targeted therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: JDQ443JDQ443 |
| Arm B | Experimental | Drug: JDQ443, Drug: TNO155JDQ443 in combination with TNO155 |
| Arm C | Experimental | Drug: JDQ443, Biological: tislelizumabJDQ443 in combination with tislelizumab |
| Arm D | Experimental | Drug: JDQ443, Drug: TNO155, Biological: tislelizumabJDQ443 in combination with TNO155 and tislelizumab |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JDQ443KRAS G12C inhibitor | Drug | Arm A, Arm B, Arm C, Arm D |
| TNO155SHP2 inhibitor | Drug | Arm B, Arm D |
| tislelizumabAnti PD1 antibody | Biological | Arm C, Arm D |
Primary outcome
Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
Time frame: 21 days
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)
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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)
Time frame: 24 months
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
17 secondary outcomes
Dose Escalation and Expansion: ORR per RECIST v1.1
Time frame: 24 months
Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1
Time frame: 24 months
Dose Escalation and Expansion: Progression-free survival (PFS) per RECIST v1.1, Overall Survival (OS)
Time frame: 24 months
Dose Escalation and Expansion: Duration of Response (DOR) per RECIST v1.1
Time frame: 24 months
Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1
Time frame: 24 months
Dose Escalation and Expansion: Plasma or serum concentration vs time profiles (AUC) by treatment
Time frame: Up to 24 months
Dose Escalation and Expansion: Plasma concentration (Cmax) by treatment
Time frame: Up to 24 months
Dose Escalation and Expansion: Time to achieve Cmax (Tmax) by treatment
Time frame: Up to 24 months
Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment
Time frame: Up to 24 months
Dose Expansion: Dose intensity by treatment
Time frame: 24 months
Dose Expansion: Frequency of dose interruptions and reductions, by treatment
Time frame: 24 months
Dose Expansion: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
Time frame: 21 days
Dose Expansion: Incidence and severity of AEs and SAEs by treatment
Time frame: 24 months
Dose expansion: Intracranial disease control rate (IDCR) per mRANO-BM
Time frame: 24 months
Dose expansion: Best overall intracranial response (BOIR) per mRANO-BM
Time frame: 24 months
Dose expansion: Intracranial progression free survival (IPFS) per mRANO-BM
Time frame: 24 months
Dose expansion: Duration of intracranial response (DOIR) per mRANO-BM
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 36399068Lorthiois 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JDQ443, TNO155 and tislelizumab in people with KRAS G12C Mutant Solid Tumors and Carcinoma, Non-Small-Cell Lung, run by Novartis Pharmaceuticals at 38 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Spain, United States, Japan, Germany, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment (time frame: 21 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.