Trials Sponsors Conditions Drugs Pricing

Conditions

Cetuximab N01 Colorectal Cancer Fulzerasib KRAS G12C Mutant Advanced Solid Tumors

Keywords

fulzerasibcetuximab N01chemotherapy-freeKRAS G12C mutantlocally advanced colorectal cancer

Outcome Measures

Primary Outcomes (1)

overall response rate
the proportion of patients achieving pCR or cCR after neoadjuvant therapy
1 year

Secondary Outcomes (3)

objective response rate
1 year
1-year disease -free survival rate
1 year
3-year disease -free survival rate
3 years

Study Arms (1)

Arm A

EXPERIMENTAL

neoadjuvant therapy with fulzerasib and cetuximab N01

Drug: fulzerasib; cetuximab N01

Interventions

fulzerasib; cetuximab N01Drug

Eligible subjects will receive neoadjuvant therapy comprising fulzerasib ((qd, po, d1-28) and cetuximab N01 (500 mg/m², IV, q2w) for two months

Arm A

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
fulzerasib; cetuximab N01
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
Age: 18-80 years old, PS score 0-1;

Sponsors & Collaborators

Zhejiang University
Otherlead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Kefeng Ding, PhDCONTACT86-571-87784827 dingkefeng@zju.edu.cn

Kefeng Ding, PhDPRINCIPAL INVESTIGATOR

Related Publications (11)

Rona Yaeger et al. A phase 1b study of sotorasib combined with panitumumab as second-line treatment of KRAS G12C-mutated colorectal cancer. JCO 42, 128-128(2024).
BACKGROUND
Ying Yuan et al. Efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer harboring KRASG12C mutation: Preliminary results from a pooled analysis of two phase I studies. JCO 41, 3586-3586(2023).
BACKGROUND
Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):265-270. doi: 10.1038/s41591-023-02717-6. Epub 2024 Jan 4.
PMID: 38177853BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

Kefeng Ding, PhD
Second Affiliated Hospital, Zhejiang University, School of Medicine
PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefeng Ding, PhD

CONTACT

86-571-87784720 dingkefeng@zju.edu.cn

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start

April 30, 2026

Actual (reported)

Primary Completion

December 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

Those who meet any of the following criteria will not be included in this trial:
Patients with MSI-H/dMMR present;
Patients with multiple metastases that cannot be resected;
Combined diseases and medical history:
Has had or is currently suffering from other malignant tumors within the past 3 years. The following situations can be included in the group:
Cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\];
Patients with active inflammatory bowel disease within the first 4 weeks of enrollment;
Uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage;
Unrelieved toxic reactions above CTCAE grade 1 caused by any previous anti-tumor treatment (excluding hair loss and ≤ grade 2 neurotoxicity caused by oxaliplatin);
Within 4 weeks prior to the start of the study, any bleeding events ≥ CTCAE grade 3 occurred in patients with unhealed wounds, ulcers, or fractures;
History of arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
Individuals with a history of substance abuse involving psychotropic drugs who are unable to quit;
Subjects with any severe and/or uncontrolled diseases, including: uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg despite standard antihypertensive treatment); myocardial ischemia or myocardial infarction ≥grade 2, arrhythmia (QTc ≥450 ms in males, QTc ≥470 ms in females, and ≥grade 2 congestive heart failure (New York Heart Association (NYHA) classification); active or uncontrolled severe infections (≥CTC AE grade 2 infection); cirrhosis, active hepatitis\*; (\*Active hepatitis \[Hepatitis B reference: HBsAg positive and HBV DNA positive (\>2500 copies/mL or \>500 IU/mL); Hepatitis C reference: HCV antibody positive and HCV viral load exceeding the upper limit of normal\] Note: For subjects meeting enrollment criteria, those with hepatitis B surface antigen positive or hepatitis B core antibody positive, or hepatitis C patients, must receive continuous antiviral treatment to prevent viral activation); renal failure requiring hemodialysis or peritoneal dialysis; history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplantation history; poorly controlled diabetes (fasting blood glucose (FBG) \>10 mmol/L); urinalysis indicating proteinuria ≥++, and confirmed 24-hour urine protein quantification \>1.0g; a history of confirmed neurological or psychiatric disorders requiring treatment, including epilepsy or dementia.
Tumor-related symptoms and treatment: Previously received targeted drug therapy (including G12C inhibitors, bevacizumab, etc.);
According to the investigator's judgment, subjects with serious diseases that pose a significant risk to their safety or affect the completion of the study, or those deemed ineligible for enrollment due to other reasons.

Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Allen C, Barber RM, Barregard L, Bhutta ZA, Brenner H, Dicker DJ, Chimed-Orchir O, Dandona R, Dandona L, Fleming T, Forouzanfar MH, Hancock J, Hay RJ, Hunter-Merrill R, Huynh C, Hosgood HD, Johnson CO, Jonas JB, Khubchandani J, Kumar GA, Kutz M, Lan Q, Larson HJ, Liang X, Lim SS, Lopez AD, MacIntyre MF, Marczak L, Marquez N, Mokdad AH, Pinho C, Pourmalek F, Salomon JA, Sanabria JR, Sandar L, Sartorius B, Schwartz SM, Shackelford KA, Shibuya K, Stanaway J, Steiner C, Sun J, Takahashi K, Vollset SE, Vos T, Wagner JA, Wang H, Westerman R, Zeeb H, Zoeckler L, Abd-Allah F, Ahmed MB, Alabed S, Alam NK, Aldhahri SF, Alem G, Alemayohu MA, Ali R, Al-Raddadi R, Amare A, Amoako Y, Artaman A, Asayesh H, Atnafu N, Awasthi A, Saleem HB, Barac A, Bedi N, Bensenor I, Berhane A, Bernabe E, Betsu B, Binagwaho A, Boneya D, Campos-Nonato I, Castaneda-Orjuela C, Catala-Lopez F, Chiang P, Chibueze C, Chitheer A, Choi JY, Cowie B, Damtew S, das Neves J, Dey S, Dharmaratne S, Dhillon P, Ding E, Driscoll T, Ekwueme D, Endries AY, Farvid M, Farzadfar F, Fernandes J, Fischer F, G/Hiwot TT, Gebru A, Gopalani S, Hailu A, Horino M, Horita N, Husseini A, Huybrechts I, Inoue M, Islami F, Jakovljevic M, James S, Javanbakht M, Jee SH, Kasaeian A, Kedir MS, Khader YS, Khang YH, Kim D, Leigh J, Linn S, Lunevicius R, El Razek HMA, Malekzadeh R, Malta DC, Marcenes W, Markos D, Melaku YA, Meles KG, Mendoza W, Mengiste DT, Meretoja TJ, Miller TR, Mohammad KA, Mohammadi A, Mohammed S, Moradi-Lakeh M, Nagel G, Nand D, Le Nguyen Q, Nolte S, Ogbo FA, Oladimeji KE, Oren E, Pa M, Park EK, Pereira DM, Plass D, Qorbani M, Radfar A, Rafay A, Rahman M, Rana SM, Soreide K, Satpathy M, Sawhney M, Sepanlou SG, Shaikh MA, She J, Shiue I, Shore HR, Shrime MG, So S, Soneji S, Stathopoulou V, Stroumpoulis K, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tadese F, Tedla BA, Tessema GA, Thakur JS, Tran BX, Ukwaja KN, Uzochukwu BSC, Vlassov VV, Weiderpass E, Wubshet Terefe M, Yebyo HG, Yimam HH, Yonemoto N, Younis MZ, Yu C, Zaidi Z, Zaki MES, Zenebe ZM, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-years for 32 Cancer Groups, 1990 to 2015: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2017 Apr 1;3(4):524-548. doi: 10.1001/jamaoncol.2016.5688.

PMID: 27918777BACKGROUND

Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Arm A

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Arm A

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations