UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062434 |
|---|---|
| Receipt number | R000071345 |
| Scientific Title | A phase II study of sotorasib plus panitumumab rechallenge in patients with KRAS G12C mutant metastatic colorectal cancer |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/01 10:30:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase II study of sotorasib plus panitumumab rechallenge in patients with KRAS G12C mutant metastatic colorectal cancer
Acronym
SOLEIL study
Scientific Title
A phase II study of sotorasib plus panitumumab rechallenge in patients with KRAS G12C mutant metastatic colorectal cancer
Scientific Title:Acronym
SOLEIL study
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of sotorasib plus panitumumab rechallenge in patients with KRAS G12C mutant metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate by central review
Key secondary outcomes
Objective response rate by investigator's assessment
Duration of response
Best percentage change in tumor size from baseline
Disease control rate
Progression-free survival
Overall survival
Incidences of adverse events
Association between baseline ctDNA genomic profiles and the efficacy of the study treatment
Genomic alterations in ctDNA at week 4 and at disease progression
Association between the percentage change in KRAS G12C VAF from baseline to week 4 and the efficacy of the study treatment
Association between the treatment-free intervals of KRAS G12C inhibitors and anti-EGFR antibodies and the efficacy of the study treatment
Association between the response to prior treatment containing a KRAS G12C inhibitor plus an anti-EGFR antibody and the efficacy of the study treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sotorasib is administered orally at a dose of 960 mg once daily. Panitumumab is administered as an intravenous infusion at a dose of 6 mg/kg every 2 weeks. Each treatment cycle is 14 days.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to curative resection, excluding appendiceal and anal canal cancers
2. KRAS G12C mutation confirmed by RAS mutation testing performed using tumor tissue
3. Prior treatment with a fluoropyrimidine-containing systemic therapy that included oxaliplatin or irinotecan. Patients with microsatellite instability-high (MSI-H) tumors must also have received prior treatment with an anti-PD-1 antibody
4. Prior treatment with combination therapy comprising a KRAS G12C inhibitor and an anti-EGFR antibody, with a best overall response of CR, PR, or SD lasting at least 5 months
5. Radiographic progressive disease (PD) or clinical progression of the underlying disease confirmed within 6 weeks after the last dose of the KRAS G12C inhibitor, followed by at least one subsequent systemic therapy regimen
6. An interval of at least 4 months between the last dose of the KRAS G12C inhibitor and the initiation of protocol treatment
7. At least one measurable lesion according to the RECIST version 1.1
8. ECOG PS of 0-2
9. Age of 18 years or older at the time of informed consent
10. Ability to take oral medication
11. Life expectancy of at least 3 months
12. Adequate organ function
13. Written informed consent for participation in the study provided by the patient after receiving an adequate explanation of the study
14. Written informed consent for blood collection for ctDNA analysis provided by the patient after receiving an adequate explanation of the procedure
Key exclusion criteria
1. Concurrent malignancy requiring treatment
2. Symptomatic, unstable, or clinically uncontrolled metastases to the central nervous system, including the brain, spinal cord, or meninges
3. Ascites, pleural effusion, or pericardial effusion requiring drainage
4. Localized infection requiring treatment or active systemic infection
5. Clinically significant psychiatric disorder that, in the investigator's judgment, would preclude participation in the study
6. Interstitial pneumonitis or pulmonary fibrosis requiring treatment
7. Planned initiation of protocol treatment before the scheduled date of the next dose of the most recent anticancer therapy
8. Unresolved adverse events of CTCAE Grade 2 or higher resulting from prior therapy, except for anemia, alopecia, skin hyperpigmentation, oxaliplatin-induced peripheral neuropathy, and hypertension or proteinuria caused by angiogenesis inhibitors
9. History of a serious allergic reaction to a KRAS G12C inhibitor or an anti-EGFR antibody
10. History of myocardial infarction or unstable angina within 6 months before enrollment
11. Women who are pregnant, breastfeeding, may currently be pregnant, or are unwilling to use adequate contraception
12. Any other condition that, in the judgment of the principal investigator or a subinvestigator, makes the patient unsuitable for participation in the study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Masuishi |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan
TEL
052-762-6111
tmasuishi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Mizuno |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan
TEL
052-762-6111
Homepage URL
ta.mizuno@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Institutional Review Board
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan
Tel
052-762-6111
irb@aichi-cc.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 01 | Day |
Last modified on
| 2026 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071345
