Everolimus in CDK12-Deficient Metastatic Colorectal Cancer (EVER-RECODE)

Starting soon · Phase 1/Phase 2

Conditions studied: Colorectal Cancer

In brief

This is a prospective, open-label, multicenter, single-arm Phase Ib/II study evaluating the safety and preliminary efficacy of everolimus in patients with CDK12-deficient refractory metastatic colorectal cancer.

Key facts

Study ID

NCT07435584

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

38

Starts

2026-03-01

Expected to finish

2028-12-31

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand and voluntarily sign an ethics committee-approved informed consent form and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
• Age 18 to 80 years (inclusive) at the time of signing informed consent; male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Estimated life expectancy ≥12 weeks.
• CDK12 deficiency confirmed by immunohistochemistry (IHC).
• Histologically confirmed metastatic colorectal cancer with documented disease progression after prior standard systemic antitumor therapies, including but not limited to oxaliplatin, fluoropyrimidine, and irinotecan.
• o Patients with deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) tumors must have experienced disease progression following anti-PD-1/PD-L1 therapy.
• At least one measurable lesion according to RECIST version 1.1, defined as:
• Non-nodal lesions ≥10 mm in longest diameter by CT scan (slice thickness ≤5 mm);
• Malignant lymph nodes with short axis ≥15 mm by CT scan (slice thickness ≤5 mm recommended).
• Adequate organ function meeting all of the following criteria:
• Hematologic (without growth factor support or transfusion within 7 days prior to testing):
• Absolute neutrophil count ≥1.5 × 10⁹/L
• Platelet count ≥75 × 10⁹/L
• Hemoglobin ≥90 g/L
• Biochemical:
• Total bilirubin ≤1.5 × upper limit of normal (ULN)
• AST and ALT ≤2.5 × ULN
• Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min (calculated using Cockcroft-Gault formula)
• Coagulation:
• International normalized ratio (INR) ≤1.5
• Activated partial thromboplastin time (aPTT or PTT) ≤1.5 × ULN
• Absence of high-risk conditions, including:
• Active or major cardiovascular events within 6 months (e.g., myocardial infarction, severe heart failure, stroke);
• Severe pulmonary dysfunction requiring long-term oxygen therapy or interstitial lung disease/pulmonary fibrosis;

You may not qualify if…

• Participants meeting any of the following criteria will be excluded:
• Untreated or active central nervous system (CNS) metastases. Patients with a history of leptomeningeal metastases or current leptomeningeal disease.
• Receipt of systemic antitumor therapy within 4 weeks prior to initiation of study treatment.
• For prior small-molecule targeted therapy: the interval between the end of prior therapy and first study dose must be ≥5 half-lives of the drug or ≥7 days, whichever is longer.
• For prior traditional Chinese antitumor medicines: ≥2 weeks washout is required.
• Palliative radiotherapy to non-target lesions, radioactive seed implantation, radiofrequency ablation, or similar local therapy within 28 days prior to first study dose.
• Toxicities or complications from prior therapies that have not recovered to NCI-CTCAE grade ≤1 or to eligibility-specified levels.
• o Patients with stable grade ≤2 toxicities may be enrolled at investigator discretion if no safety risk exists (e.g., immune checkpoint inhibitor-related type 1 diabetes or hypothyroidism controlled with hormone replacement therapy).
• Within 28 days prior to first study dose: inability to swallow oral medication, chronic diarrhea, active gastroenteritis, gastrointestinal perforation, prior major gastrointestinal resection, colitis, or other conditions that may impair drug administration or absorption.
• Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage within 2 weeks prior to study treatment.
• Small asymptomatic ascites detected by imaging is allowed.
• Uncontrolled or moderate-to-large pleural effusion or pericardial effusion.
• Evidence of intestinal obstruction or signs/symptoms of obstruction at baseline.
• Patients who underwent surgery with complete resolution of obstruction may be screened.
• Presence of an indwelling intestinal stent at screening.
• Uncontrolled or severe cardiovascular disease, including:
• Severe or unstable congestive heart failure (NYHA class II-IV)
• Myocardial infarction within 6 months prior to first dose
• Unstable angina within 1 month prior to treatment
• Unstable arrhythmia
• History of or concurrent malignancies other than colorectal cancer, unless in complete remission for ≥5 years prior to screening and not requiring ongoing therapy, except:
• Basal cell carcinoma of the skin
• Superficial bladder cancer
• Cutaneous squamous cell carcinoma
• Cervical carcinoma in situ

Full record on ClinicalTrials.gov

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