An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT07288359

Title field or adapter rule

{'original_value': 'An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:27.771721+00:00

Published At

2026-10-29T00:00:00+00:00

Record Updated At

2026-10-29

Source Retrieved At

2026-10-31T22:19:00.066997+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

["Advanced HR+/HER2- Breast Cancer", "Advanced CCNE1-amplified Solid Tumors", "Metastatic Castration-resistant Prostate Cancer"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-29", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT07288359"

protocolSection.identificationModule.officialTitle

"An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1", "PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Advanced HR+/HER2- Breast Cancer (protocolSection.conditionsModule.conditions)
• Advanced CCNE1-amplified Solid Tumors (protocolSection.conditionsModule.conditions)
• Metastatic Castration-resistant Prostate Cancer (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['GVV858 Single Agent (Arm A)', 'GVV858 in combination with fulvestrant (Arm B)', 'GVV858 in combination with fulvestrant (Arm D)', 'GVV858 in combination with fulvestrant (Arm E)', 'GVV858 in combination with letrozole (Arm C)'], 'description': 'Experimental', 'name': 'GVV858', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['GVV858 in combination with fulvestrant (Arm B)', 'GVV858 in combination with fulvestrant (Arm D)', 'GVV858 in combination with fulvestrant (Arm E)'], 'description': 'Approved medication', 'name': 'Fulvestrant', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['GVV858 in combination with letrozole (Arm C)'], 'description': 'Approved medication', 'name': 'Letrozole', 'type': 'DRUG'} (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

• GVV858 (protocolSection.armsInterventionsModule.interventions[].name)
• Fulvestrant (protocolSection.armsInterventionsModule.interventions[].name)
• Letrozole (protocolSection.armsInterventionsModule.interventions[].name)

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

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