A Phase 1 Theranostic Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of SKL35501, an Alpha-Emitting Radiopharmaceutical Targeting NTSR1, With SKL35502 as Companion Imaging Agent in Adult Patients With Selected Advanced Solid Tumors

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT07812805

Title field or adapter rule

{'original_value': 'A Phase 1 Theranostic Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of SKL35501, an Alpha-Emitting Radiopharmaceutical Targeting NTSR1, With SKL35502 as Companion Imaging Agent in Adult Patients With Selected Advanced Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:26.266237+00:00

Published At

2026-09-10T00:00:00+00:00

Record Updated At

2026-09-10

Source Retrieved At

2026-10-31T22:17:56.788771+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Selected Advanced Solid Tumors", "Colorectal Cancer (CRC)", "Pancreatic Ductal Adenocarcinoma (PDAC)", "Biliary Tract Cancer (BTC)", "Gastric Cancer (GC)", "Esophageal Cancer (EC)", "Head and Neck Squamous Cell Cancer (HNSCC)"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-09-10", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT07812805"

protocolSection.identificationModule.officialTitle

"A Phase 1 Theranostic Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of SKL35501, an Alpha-Emitting Radiopharmaceutical Targeting NTSR1, With SKL35502 as Companion Imaging Agent in Adult Patients With Selected Advanced Solid Tumors"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Selected Advanced Solid Tumors (protocolSection.conditionsModule.conditions)
• Colorectal Cancer (CRC) (protocolSection.conditionsModule.conditions)
• Pancreatic Ductal Adenocarcinoma (PDAC) (protocolSection.conditionsModule.conditions)
• Biliary Tract Cancer (BTC) (protocolSection.conditionsModule.conditions)
• Gastric Cancer (GC) (protocolSection.conditionsModule.conditions)
• Esophageal Cancer (EC) (protocolSection.conditionsModule.conditions)
• Head and Neck Squamous Cell Cancer (HNSCC) (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['SKL35501 High Dose', 'SKL35501 Low Dose'], 'description': 'Therapeutic agent that consists of an NTSR1-targeting small molecule linked to alpha emitter 225Ac to induce killing of NTSR1-expressing tumor cells', 'name': 'SKL35501', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['SKL35501 High Dose', 'SKL35501 Low Dose'], 'description': 'Imaging agent that consists of an NTSR1-targeting small molecule linked to 111In to detect NTSR1-expressing tumors via SPECT imaging', 'name': 'SKL35502', 'type': 'DIAGNOSTIC_TEST'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• SKL35501 (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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