Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With A… (NCT05417594) | Clinical Trial Compass
RecruitingPhase 1/2
Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies
United States695 participantsStarted 2022-06-24
Plain-language summary
This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progressed.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed HER2-negative carcinoma of the breast with recurrent locally advanced or metastatic disease and evidence of a predicted loss of function germline or tumour mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D,
✓. Histologically or cytologically confirmed relapsed advanced ovarian, fallopian tube or primary peritoneal cancer and evidence of a predicted loss of function germline or tumour mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D
✓. Histologically or cytologically confirmed advanced/metastatic castration-resistant prostate cancer (CRPC) and evidence of a predicted loss of function germline or tumour mutation in in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.
✓. Histologically or cytologically confirmed advanced/metastatic pancreatic cancer and evidence of a predicted loss of function germline or tumour mutation in in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
✓. Must have previously treated and progressing or untreated brain metastases confirmed by brain MRI at screening that do not need immediate local therapy.
✓. Should have stable neurological function for ≥ 14 days prior to signing the main study ICF.
✓. If receiving steroids, the dose should be stable or decreasing for ≥ 14 days prior to signing the main study ICF.
✓. Breast cancer must be IHC 3+ or IHC 2+/ISH-positive or IHC 2+/ISH-negative or IHC 1+ as determined by local testing using current American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines for scoring HER2 + breast cancer.
Exclusion criteria
What they're measuring
1
Incidence of Adverse Events (AEs), and Serious Adverse Events (SAEs)
Timeframe: From first dose to post-treatment follow-up (approximately three years)
2
Changes from baseline in laboratory findings, electrocardiograms (ECGs), and vital signs
Timeframe: From last assessment prior to first dose to post-treatment follow up visit (approximately three years)
3
Change from baseline Eastern Cooperative Oncology Group performance status (ECOG PS)
Timeframe: From last assessment prior to first dose to post-treatment follow up visit (approximately three years)