Trial · NCT07435584
Everolimus in CDK12-Deficient Metastatic Colorectal Cancer (EVER-RECODE)
NCT07435584, Phase 1, Phase 2, Not yet recruiting, Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Everolimus in CDK12-Deficient Metastatic Colorectal Cancer (EVER-RECODE). Trials, record NCT07435584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07435584
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus in CDK12-Deficient Metastatic Colorectal Cancer (EVER-RECODE)
- NCT number
- NCT07435584
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 38 participants, estimated
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Conditions
- Colorectal Cancer
- Interventions
- Everolimus (Afinitor) tablets
- First posted
- 2026-02-27
- Last updated
- 2026-02-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Dose-Limiting Toxicities (DLTs) | First 8 weeks after initial dose | Dose-limiting toxicity (DLT) is defined as treatment-related toxicity occurring within the first 8 weeks (DLT observation window) that is assessed as definitely, probably, or possibly related to everolimus and meets any of the following criteria based on NCI-CTCAE version 5.0: * Grade ≥3 non-hematologic toxicity (excluding Grade 3 nausea/vomiting resolving within 48 hours with supportive care, Grade 3 alopecia, and Grade 3 fatigue without ECOG deterioration); * Grade 4 hematologic toxicity (including neutropenia lasting ≥7 days, thrombocytopenia with active bleeding, or hemoglobin \<60 g/L requiring urgent transfusion); * Grade 3 hematologic toxicity persisting ≥14 days without recovery to ≤Grade 2; * Treatment interruption ≥14 days due to drug-related toxicity; * Other toxicities considered by the investigator to significantly compromise patient safety. For Phase Ib study |
| Primary | Objective Response Rate (ORR) | Assessed every 8 weeks up to 24 months | Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST version 1.1. For Phase II study |
| Secondary | Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) | Up to 8 weeks | Determination of the highest dose level at which ≤1 of 6 participants experiences DLT during the first 8 weeks (3+3 design). For Phase Ib study |
| Secondary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | From first dose until end of treatment (up to 24 months) | Incidence and severity of adverse events graded according to NCI-CTCAE version 5.0. For Phase Ib and Phase II study |
| Secondary | Progression-Free Survival (PFS) | Up to 24 months | Time from first dose to disease progression per RECIST version 1.1 or death from any cause. For Phase II study |
| Secondary | Overall Survival (OS) | Up to 24 months | Time from first dose to death from any cause. For Phase II study |
| Secondary | Disease Control Rate (DCR) | Assessed every 8 weeks up to 24 months | Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1. |
| Secondary | Duration of Response (DoR) | Up to 24 months | Time from first documented response (CR or PR) to disease progression or death. For Phase II study |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07435584
GET https://conductscience.org/api/trials/v1/NCT07435584/registered