Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
PETRA
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
2 other identifiers
interventional
702
14 countries
68
Brief Summary
This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 ovarian-cancer
Started Nov 2020
Longer than P75 for phase_1 ovarian-cancer
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedStudy Start
First participant enrolled
November 12, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 28, 2027
February 19, 2026
February 1, 2026
6.5 years
October 26, 2020
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The number of subjects with adverse events/serious adverse events
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline
From time of Informed Consent to 28 + 7 days post last dose ( modules 1,2,3,5 and 6). 40+7 days post last dose for Module 4.
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
A DLT is defined as any toxicity that occurs from the first dose of study treatment (either AZD5305 or combination anti-cancer agent) up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. DLTs occurring outside the DLT window (ie, late onset toxicities) may be defined as a DLT after consultation with the sponsor and investigators, based on the emerging safety profile.
From first dose of study treatment until the end of Cycle 1.
Secondary Outcomes (33)
Best percentage change in target lesion
From Screening to confirmed progressive disease (approximately 1 year)
Objective Response Rate
From Screening to confirmed progressive disease (approximately 1 year)
Duration of Response
From Screening to confirmed progressive disease (approximately 1 year)
Progression Free Survival
From Screening to confirmed progressive disease (approximately 1 year)
Time To Response
From Screening to confirmed progressive disease (approximately 1 year)
- +28 more secondary outcomes
Study Arms (6)
Module 1: AZD5305 Monotherapy
EXPERIMENTALAZD5305 Monotherapy
Module 2: AZD5305 + Paclitaxel
EXPERIMENTALAZD5305 + Paclitaxel
Module 3: AZD5305 + Carboplatin with or without Paclitaxel
EXPERIMENTALAZD5305 + Carboplatin with or without Paclitaxel
Module 4: AZD5305 + Trastuzumab Deruxtecan
EXPERIMENTALAZD5305 + T- DXd
Module 5 AZD5305 + Datopotamab Deruxtecan
EXPERIMENTALAZD5305 + Dato-DXd
Module 6 AZD5305 + Camizestrant
EXPERIMENTALAZD5305 + Camizestrant
Interventions
Oral PARP inhibitor
IV Anti-microtubule agent
IV Platinum chemotherapeutic
Eligibility Criteria
You may qualify if:
- Age ≥ 18 at the time of screening
- Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..
- Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
- Life expectancy ≥ 12 weeks
- Progressive cancer at the time of study entry
- Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
- Adequate organ and marrow function as defined by the protocol.
- For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.
- For Part A:
- \- Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)
- For Part B:
- \- Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).
You may not qualify if:
- Treatment with any of the following:
- Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
- Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment
- Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
- Any live virus or bacterial vaccine within 28 days of the first dose of study treatment
- Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong inhibitors or inducers.
- Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
- Receiving continuous corticosteroids at a dose of \>10 mg prednisone/day or equivalent for any reason.
- Major surgery within 4 weeks of the first dose of study treatment.
- Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
- Any history of persisting (\> 2 weeks) severe pancytopenia due to any cause
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \>10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
- patient with known predisposition to bleeding (e.g., active peptic ulceration, recent \[within 6 months\] haemorrhagic stroke, proliferative diabetic retinopathy).
- Cardiac conditions as defined by the clinical study protocol
- Other cardiovascular diseases as defined by any of the following:
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (68)
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Boston, Massachusetts, 02215, United States
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New York, New York, 10021, United States
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Oklahoma City, Oklahoma, 73104, United States
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Houston, Texas, 77030, United States
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Heidelberg, 3084, Australia
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Melbourne, 3000, Australia
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Vancouver, British Columbia, V5Z 1K1, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Beijing, 100142, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Guangzhou, 510060, China
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Harbin, 150081, China
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Jining, 272029, China
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Shandong, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Taiyuan, 030001, China
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Wuhan, 430079, China
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Xi'an, 710061, China
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Brno, 656 53, Czechia
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Prague, 15006, Czechia
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Budapest, 1062, Hungary
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Milan, 20132, Italy
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Milan, 20141, Italy
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Modena, 41125, Italy
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Naples, 80131, Italy
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Padua, 35128, Italy
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Roma, 00168, Italy
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Chūōku, 104-0045, Japan
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Kōtoku, 135-8550, Japan
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Bydgoszcz, 85-796, Poland
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Gdansk, 80-214, Poland
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Gdynia, 81-519, Poland
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Grzepnica, 72-003, Poland
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Lodz, 90-302, Poland
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Torun, 87-100, Poland
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Warsaw, 02-781, Poland
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Moscow, 111123, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Moscow, 143442, Russia
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Barcelona, 08035, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28050, Spain
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Málaga, 29010, Spain
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Pozuelo de Alarcón, 28223, Spain
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Seville, 41013, Spain
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Chernivtsі, 58013, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kyiv, 03022, Ukraine
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Uzhhorod, 88000, Ukraine
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Cambridge, CB2 0QQ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Oxford, OX3 7LE, United Kingdom
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Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Illuzzi G, Staniszewska AD, Gill SJ, Pike A, McWilliams L, Critchlow SE, Cronin A, Fawell S, Hawthorne G, Jamal K, Johannes J, Leonard E, Macdonald R, Maglennon G, Nikkila J, O'Connor MJ, Smith A, Southgate H, Wilson J, Yates J, Cosulich S, Leo E. Preclinical Characterization of AZD5305, A Next-Generation, Highly Selective PARP1 Inhibitor and Trapper. Clin Cancer Res. 2022 Nov 1;28(21):4724-4736. doi: 10.1158/1078-0432.CCR-22-0301.
PMID: 35929986DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Yap
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
November 25, 2020
Study Start
November 12, 2020
Primary Completion (Estimated)
May 28, 2027
Study Completion (Estimated)
May 28, 2027
Last Updated
February 19, 2026
Record last verified: 2026-02