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NCT07461727NOT_YET_RECRUITINGanonymous

An Open-Label, Single-Arm, Dose-Escalation Phase I Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of EDB-102 in Patients With EGFR L858R-Mutant, Third-Generation TKI-Resistant Advanced Non-Small Cell Lung Cancer With Liver Metastases

Sponsor

Source record

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase

Source record

Phase 1

Modality

AI-normalized

gene therapy

Target

AI-normalized

EGFR L858R mutation in advanced non-small cell lung cancer (NSCLC)

Indication / condition

AI-normalized

Non-Small Cell Lung Cancer

Intervention

Source record

EDB-102

Source & freshness

Source record

NCT ID

NCT07461727

Original source

ClinicalTrials.gov

Source last updated

Mar 10, 2026

Ingested at

Jun 17, 2026

Internal sync

Jun 17, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT07461727

Title

An Open-Label, Single-Arm, Dose-Escalation Phase I Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of EDB-102 in Patients With EGFR L858R-Mutant, Third-Generation TKI-Resistant Advanced Non-Small Cell Lung Cancer With Liver Metastases

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

NOT_YET_RECRUITING

Phase

Phase 1

Condition raw

Non-Small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer, Liver Metastases, EGFR Gene Mutation, EGFR L858R

Condition normalized

Non-Small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer, Liver Metastases, EGFR Gene Mutation, EGFR L858R

Modality raw

gene therapy

Modality normalized

gene therapy

Target raw

EGFR L858R mutation in advanced non-small cell lung cancer (NSCLC)

Target normalized

EGFR L858R mutation in advanced non-small cell lung cancer (NSCLC)

Interventions

EDB-102

Public preview

Source record

EDB-102 represents a novel approach to treating EGFR L858R-mutant NSCLC patients who have developed resistance to third-generation TKIs, such as osimertinib. The targeted gene-editing mechanism using CRISPR-Cas9 encapsulated in lipid nanoparticles (LNPs) positions EDB-102 uniquely in the competitive landscape, particularly for patients with liver metastases. The market for NSCLC therapies is substantial, with increasing demand for innovative treatments that address resistance mechanisms. Successful outcomes in this trial could lead to significant commercial opportunities, especially if EDB-102 demonstrates improved efficacy and safety profiles compared to existing therapies. However, the competitive landscape includes established TKIs and emerging therapies targeting similar mutations, necessitating thorough diligence on market positioning and potential partnerships or licensing agreements.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

An Open-Label, Single-Arm, Dose-Escalation Phase I Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of EDB-102 in Patients With EGFR L858R-Mutant, Third-Generation TKI-Resistant Advanced Non-Small Cell Lung Cancer With Liver Metastases

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 17, 2026

NCT ID

NCT07461727

Status

NOT_YET_RECRUITING

Phase

Phase 1

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Executive brief

Investment-Ready Snapshot

EDB-102 represents a novel approach to treating EGFR L858R-mutant NSCLC patients who have developed resistance to third-generation TKIs, such as osimertinib. The targeted gene-editing mechanism using CRISPR-Cas9 encapsulated in lipid nanoparticles (LNPs) positions EDB-102 uniquely in the competitive landscape, particularly for patients with liver metastases. The market for NSCLC therapies is substantial, with increasing demand for innovative treatments that address resistance mechanisms. Successful outcomes in this trial could lead to significant commercial opportunities, especially if EDB-102 demonstrates improved efficacy and safety profiles compared to existing therapies. However, the competitive landscape includes established TKIs and emerging therapies targeting similar mutations, necessitating thorough diligence on market positioning and potential partnerships or licensing agreements.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedMar 10, 2026
Internal syncJun 17, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT07461727

Indication

Non-Small Cell Lung Cancer

Modality

gene therapy

Target

EGFR L858R mutation in advanced non-small cell lung cancer (NSCLC)

Intervention

EDB-102

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.