EfficacyPhase 2NCT05993455
A Phase 2 Basket Trial in Which Patients With Advanced Solid Tumors Carrying the KRAS G12C mUtation Receive Treatment With a Combination of Sotorasib and Panitumumab
A Phase 2 study testing Oral sotorasib + IV Panitumumab in people with Efficacy, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
Kirsten rat sarcoma (KRAS) mutation is one of the most common genetic mutations associated with tumor development in various human cancers, including pancreatic cancer, non-small cell lung cancer, and colorectal cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Efficacy
- What is being tested?
- Oral sotorasib + IV Panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2023to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have consented to participate in the KOSMOS-II observational master study.
- Age of 19 years or older.
- Histologically confirmed locally advanced or metastatic solid tumors (excluding non-small cell lung cancer and colorectal cancer) with KRAS G12C mutation detected through local next-generation sequencing analysis.
- Local advanced or metastatic disease with disease progression or unavailability of standard treatment options for the first-line anti-cancer therapy.
- Measurable lesions according to RECIST v1.1 (lesions that have not experienced disease progression after radiation therapy are excluded).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
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- Adequate bone marrow and organ function as described below:
- ① Bone Marrow: - Absolute neutrophil count (ANC) ≥ 1,500/mm3 - Platelet count (PLT) ≥ 100,000/mm3 - Hemoglobin (Hb) ≥ 9 g/dL
- ② Liver Function:
- Total bilirubin ≤ 1.5 X upper limit of normal (ULN). If liver metastasis is present, total bilirubin up to ≤ 3 X ULN is allowed. For patients with Gilbert's syndrome, total bilirubin up to ≤ 3 X ULN and direct bilirubin within the normal range is allowed.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 X ULN (or ≤ 5 X ULN if liver metastasis is present).
- ③ Renal Function: - Creatinine clearance ≥ 30 mL/min/1.73m2 (using the Cockcroft-Gault formula).
- Estimated life expectancy of at least 3 months according to the investigator's judgment.
- Ability to take oral medications.
- Understanding and compliance with the clinical trial protocol and ability to provide informed consent by signing the informed consent form.
Who cannot join
- Patients who have not received previous sotorasib treatment or monoclonal antibodies against epidermal growth factor receptor (EGFR) such as cetuximab or panitumumab.
- Absence of active brain metastasis or leptomeningeal metastasis (Patients with previously treated brain metastasis or leptomeningeal metastasis with radiation therapy and/or surgery [including radiosurgery] and are neurologically stable can be eligible for enrollment).
- No significant cardiovascular events within the past 6 months, such as:
- .NYHA Class 3 or higher congestive heart failure. .Unstable angina or myocardial infarction. .Uncontrolled or symptomatic atrial fibrillation. .QTc prolongation (> 480 milliseconds).
- No history of stroke within the past 6 months (including transient ischemic attack).
- No diagnosis of another malignancy within 2 years prior to enrollment (excluding superficial basal cell carcinoma or squamous cell carcinoma, cervical intraepithelial neoplasia, prostate cancer under active surveillance, and well-differentiated thyroid cancer that has undergone definitive surgery).
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- Pregnant or breastfeeding women.
- Participants who do not agree to effective contraception* during the clinical trial.
- Sexually active female participants of childbearing potential and their partners must agree to use medically acceptable contraception (e.g., male condoms, female condoms, or the combined use of barrier methods and spermicidal gel) during the clinical trial period and for up to 6 months after the last administration of the investigational drug.
- Male participants who have not undergone vasectomy must agree to use barrier contraception (condoms) and are prohibited from providing sperm donations until 6 months after the last administration of the investigational drug.
- Participants with active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, except under the following conditions:
- Participants who are positive for HBsAg (Hepatitis B surface antigen) can be enrolled if ALT is within the normal range and HBV DNA is <2,000 IU/ml while receiving antiviral prophylaxis for hepatitis B reactivation.
- Participants who are negative for HBsAg but positive for Hepatitis B core antibody (IgG anti-HBc) can be enrolled if HBV DNA is quantifiable but below the limit of quantification.
- Participants who are positive for anti-HCV Ab can be enrolled if HCV RNA is quantifiable but below the limit of quantification.
- Participants with planned major surgery during the clinical trial.
- Other clinically significant disorders deemed unsuitable for the clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Basket Trial in Which Patients With Advanced Solid Tumors Carrying the KRAS G12C mUtation Receive Treatment With a Combination of Sotorasib and Panitumumab (KRAUS)
Kirsten rat sarcoma (KRAS) mutation is one of the most common genetic mutations associated with tumor development in various human cancers, including pancreatic cancer, non-small cell lung cancer, and colorectal cancer. Previous studies have shown that KRAS mutations are present in approximately 70% of pancreatic cancer patients, 35% of colorectal cancer patients, 20% of non-small cell lung cancer patients, and 15% of cervical cancer patients. Patients with KRAS mutations generally have a shorter overall survival and increased resistance to treatment compared to wild-type tumors. KRAS mutations have been known for decades, but they have been considered "undruggable" as effective therapies targeting them were lacking.
Preclinical studies focusing on colorectal and non-small cell lung cancer cell lines have suggested that colorectal cancer cell lines exhibit a stronger response to EGFR signaling and activation of multiple RTKs (Receptor Tyrosine Kinases) than non-small cell lung cancer cell lines. As a result, they show poorer responses to KRAS G12C inhibitors, leading to the development of initial and acquired resistance to KRAS G12C inhibition. Based on this hypothesis, a phase 1-2 clinical trial, known as the KRYSTAL-1 study, was conducted in patients with metastatic colorectal cancer. The study demonstrated that the objective response rate was 19% with adagrasib monotherapy and 46% with the combination of adagrasib and cetuximab (an EGFR inhibitor), indicating that the addition of an EGFR inhibitor can overcome resistance. Building on this hypothesis, a phase 3 trial is currently underway for KRAS G12C inhibition plus EGFR blockade in metastatic colorectal cancer (ClinicalTrials.gov identifiers: NCT04793958, NCT05198934).
In this study, the aim is to investigate the efficacy of sotorasib (KRAS G12C inhibitor) plus panitumumab (EGFR inhibitor) in patients with advanced solid tumors harboring KRAS G12C mutations, who have failed standard treatments.
- Conditions
- Efficacy
- Being tested
- Oral sotorasib + IV Panitumumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral sotorasib + IV PanitumumabDrug
Oral sotorasib at a dose of 960 mg once daily with Panitumumab is administered intravenously (IV) at a dose of 6 mg/kg every 14 days, infused over 60 minutes (≤ 1,000 mg) or 90 minutes (> 1,000 mg).
| Study group | Role | What they receive |
|---|---|---|
| Oral sotorasib + IV Panitumumab | Experimental | Oral sotorasib at a dose of 960 mg once daily with Panitumumab is administered intravenously (IV) at a dose of 6 mg/kg every 14 days, infused over 60 minutes (≤ 1,000 mg) or 90 minutes (> 1,000 mg). Receives: Drug: Oral sotorasib + IV Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate based on RECIST v1.1
Imaging tumor assessment time point after Cycle 1 Day 1 (each cycle is 14 days).
Measured: Imaging tumor assessment time point after Cycle 1 Day 1 (each cycle is 14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start3 Jul 2023
- Primary completion4 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee, Soo Hyeon, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993455
- Sponsor's protocol ID
- KRAUS
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Basket Trial in Which Patients With Advanced Solid Tumors Carrying the KRAS G12C mUtation Receive Treatment With a Combination of Sotorasib and Panitumumab (KRAUS)
- ClinicalTrials.gov ID
- NCT05993455
- Acronym / sponsor ID
- KRAUS
- Conditions
- Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 4 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Aug 2023 (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.
Kirsten rat sarcoma (KRAS) mutation is one of the most common genetic mutations associated with tumor development in various human cancers, including pancreatic cancer, non-small cell lung cancer, and colorectal cancer. Previous studies have shown that KRAS mutations are present in approximately 70% of pancreatic cancer patients, 35% of colorectal cancer patients, 20% of non-small cell lung cancer patients, and 15% of cervical cancer patients. Patients with KRAS mutations generally have a shorter overall survival and increased resistance to treatment compared to wild-type tumors. KRAS mutations have been known for decades, but they have been considered "undruggable" as effective therapies targeting them were lacking.
Preclinical studies focusing on colorectal and non-small cell lung cancer cell lines have suggested that colorectal cancer cell lines exhibit a stronger response to EGFR signaling and activation of multiple RTKs (Receptor Tyrosine Kinases) than non-small cell lung cancer cell lines. As a result, they show poorer responses to KRAS G12C inhibitors, leading to the development of initial and acquired resistance to KRAS G12C inhibition. Based on this hypothesis, a phase 1-2 clinical trial, known as the KRYSTAL-1 study, was conducted in patients with metastatic colorectal cancer. The study demonstrated that the objective response rate was 19% with adagrasib monotherapy and 46% with the combination of adagrasib and cetuximab (an EGFR inhibitor), indicating that the addition of an EGFR inhibitor can overcome resistance. Building on this hypothesis, a phase 3 trial is currently underway for KRAS G12C inhibition plus EGFR blockade in metastatic colorectal cancer (ClinicalTrials.gov identifiers: NCT04793958, NCT05198934).
In this study, the aim is to investigate the efficacy of sotorasib (KRAS G12C inhibitor) plus panitumumab (EGFR inhibitor) in patients with advanced solid tumors harboring KRAS G12C mutations, who have failed standard treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral sotorasib + IV Panitumumab | Experimental | Drug: Oral sotorasib + IV PanitumumabOral sotorasib at a dose of 960 mg once daily with Panitumumab is administered intravenously (IV) at a dose of 6 mg/kg every 14 days, infused over 60 minutes (≤ 1,000 mg) or 90 minutes (> 1,000 mg). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients who have consented to participate in the KOSMOS-II observational master study.
- Age of 19 years or older.
- Histologically confirmed locally advanced or metastatic solid tumors (excluding non-small cell lung cancer and colorectal cancer) with KRAS G12C mutation detected through local next-generation sequencing analysis.
- Local advanced or metastatic disease with disease progression or unavailability of standard treatment options for the first-line anti-cancer therapy.
- Measurable lesions according to RECIST v1.1 (lesions that have not experienced disease progression after radiation therapy are excluded).
Key exclusion criteria (16 listed)
- Patients who have not received previous sotorasib treatment or monoclonal antibodies against epidermal growth factor receptor (EGFR) such as cetuximab or panitumumab.
- Absence of active brain metastasis or leptomeningeal metastasis (Patients with previously treated brain metastasis or leptomeningeal metastasis with radiation therapy and/or surgery [including radiosurgery] and are neurologically stable can be eligible for enrollment).
- No significant cardiovascular events within the past 6 months, such as:
- .NYHA Class 3 or higher congestive heart failure. .Unstable angina or myocardial infarction. .Uncontrolled or symptomatic atrial fibrillation. .QTc prolongation (> 480 milliseconds).
- No history of stroke within the past 6 months (including transient ischemic attack).
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 |
|---|---|---|
| Oral sotorasib + IV PanitumumabOral sotorasib at a dose of 960 mg once daily with Panitumumab is administered intravenously (IV) at a dose of 6 mg/kg every 14 days, infused over 60 minutes (≤ 1,000 mg) or 90 minutes (> 1,000 mg). | Drug | Oral sotorasib + IV Panitumumab |
Primary outcome
Objective response rate based on RECIST v1.1
Time frame: Imaging tumor assessment time point after Cycle 1 Day 1 (each cycle is 14 days).
Imaging tumor assessment time point after Cycle 1 Day 1 (each cycle is 14 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral sotorasib + IV Panitumumab in people with Efficacy, run by Korea University Anam Hospital at 1 site in South Korea.
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 15 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 phase mean?
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?
Results are not available in the source record.
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?
Objective response rate based on RECIST v1.1 (time frame: Imaging tumor assessment time point after Cycle 1 Day 1 (each cycle is 14 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2023.