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A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT04644068
Title field or adapter rule
{'original_value': 'A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At
2026-10-31T23:27:25.285865+00:00
Published At
2026-09-21T00:00:00+00:00
Record Updated At
2026-09-21
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
["Ovarian Cancer", "Breast Cancer", "Pancreatic Cancer", "Prostate Cancer", "Additional Indications Below for Module 4 and 5", "Non-small Cell Lung Cancer", "Colorectal Cancer", "Bladder Cancer", "Gastric Cancer", "Biliary Cancer", "Cervical Cancer", "Endometrial Cancer", "Small Cell Lung Cancer Only in Module 5"]
protocolSection.statusModule.lastUpdatePostDateStruct
{"date": "2026-09-21", "type": "ACTUAL"}
protocolSection.identificationModule.nctId
"NCT04644068"
protocolSection.identificationModule.officialTitle
"A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies"
protocolSection.statusModule.overallStatus
"ACTIVE_NOT_RECRUITING"
protocolSection.designModule.phases
["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct
null

Study condition terms

  • Ovarian Cancer (protocolSection.conditionsModule.conditions)
  • Breast Cancer (protocolSection.conditionsModule.conditions)
  • Pancreatic Cancer (protocolSection.conditionsModule.conditions)
  • Prostate Cancer (protocolSection.conditionsModule.conditions)
  • Additional Indications Below for Module 4 and 5 (protocolSection.conditionsModule.conditions)
  • Non-small Cell Lung Cancer (protocolSection.conditionsModule.conditions)
  • Colorectal Cancer (protocolSection.conditionsModule.conditions)
  • Bladder Cancer (protocolSection.conditionsModule.conditions)
  • Gastric Cancer (protocolSection.conditionsModule.conditions)
  • Biliary Cancer (protocolSection.conditionsModule.conditions)
  • Cervical Cancer (protocolSection.conditionsModule.conditions)
  • Endometrial Cancer (protocolSection.conditionsModule.conditions)
  • Small Cell Lung Cancer Only in Module 5 (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

  • {'armGroupLabels': ['Module 1: AZD5305 Monotherapy', 'Module 2: AZD5305 + Paclitaxel', 'Module 3: AZD5305 + Carboplatin with or without Paclitaxel', 'Module 4: AZD5305 + Trastuzumab Deruxtecan', 'Module 5 AZD5305 + Datopotamab Deruxtecan', 'Module 6 AZD5305 + Camizestrant'], 'description': 'Oral PARP inhibitor', 'name': 'AZD5305', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Module 2: AZD5305 + Paclitaxel', 'Module 3: AZD5305 + Carboplatin with or without Paclitaxel'], 'description': 'IV Anti-microtubule agent', 'name': 'Paclitaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Module 3: AZD5305 + Carboplatin with or without Paclitaxel'], 'description': 'IV Platinum chemotherapeutic', 'name': 'Carboplatin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Module 4: AZD5305 + Trastuzumab Deruxtecan'], 'description': 'IV Antibody-drug conjugate', 'name': 'T- Dxd', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Module 5 AZD5305 + Datopotamab Deruxtecan'], 'description': 'IV Antibody-drug conjugate', 'name': 'Dato-DXd', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Module 6 AZD5305 + Camizestrant'], 'description': 'Oral SERD Molecule', 'name': 'Camizestrant', '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

  • AZD5305 (protocolSection.armsInterventionsModule.interventions[].name)
  • Paclitaxel (protocolSection.armsInterventionsModule.interventions[].name)
  • Carboplatin (protocolSection.armsInterventionsModule.interventions[].name)
  • T- Dxd (protocolSection.armsInterventionsModule.interventions[].name)
  • Dato-DXd (protocolSection.armsInterventionsModule.interventions[].name)
  • Camizestrant (protocolSection.armsInterventionsModule.interventions[].name)

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

This index keeps the source fields it imported; it may not contain the complete original record. Verify wording and context in the linked source.