IDE574 is a synthetically manufactured small molecule inhibitor that co-targets the lysine acetyltransferase enzymes KAT6 and KAT7.
The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IDE574 as monotherapy in participants with locally advanced or metastatic solid tumors and as combination therapy with fulvestrant in participants with advanced or metastatic ER+, HER2- breast cancer.
Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on/after at least one line of standard of care therapy or are intolerant to additional effective therapies.
Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4/6 inhibitor
Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only)
Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age <60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries
Known symptomatic brain metastases or leptomeningeal metastasis
Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor.
Have impairment of GI function or GI disease that may significantly alter the absorption of IDE574.
Have active liver or biliary disease.
Parallel
IDE574
DrugIDE574
Fulvestrant injection
DrugFulvestrant Injection
Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation
incidence of DLT; incidence and severity of AEs/serious adverse events (SAEs) graded based on CTCAE V6.0
Safety and Tolerability of IDE574 in Part 1B Monotherapy Dose expansion based on incidence and severity of AEs/SAEs
Incidence and severity of AEs/SAEs graded based on CTCAE V6.0
To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on the ORR per RECIST version 1.1
Objective Response Rate (ORR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on DOR per RECIST version 1.1.
Duration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on the ORR per RECIST version 1.1
Objective Response Rate (ORR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on DOR per RECIST version 1.1.
Duration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on Clinical Benefit Rate (CBR)
CBR will be assessed based on the proportion of participants with a Best Overall Response (BOR) of CR, PR or SD lasting for 24 weeks per RECIST version 1.1 from the first dose.
Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on Disease control rate
Disease Control Rate (DCR) is the proportion of participants with a BOR of CR, PR, and SD lasting for at least 6 weeks (± 7 days) from the first dose per RECIST version 1.1
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