Not Yet RecruitingPhase 1/2

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

38 participantsStarted 2026-03-01

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.
✓. At least one measurable lesion according to RECIST version 1.1, defined as:
✓. Adequate organ function meeting all of the following criteria:

Exclusion criteria

✕. 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.
✕. 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.
✕. 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.
✕. Evidence of intestinal obstruction or signs/symptoms of obstruction at baseline.
✕. Uncontrolled or severe cardiovascular disease, including:

What they're measuring

Incidence of Dose-Limiting Toxicities (DLTs)

Timeframe: First 8 weeks after initial dose

Objective Response Rate (ORR)

Timeframe: Assessed every 8 weeks up to 24 months

Trial details

NCT IDNCT07435584

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Xiangxing Kong

+8615068803769 kongxiangxing@zju.edu.cn

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