A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies

Exclusion Criteria

• •Prior therapy with a specific CDK12/13 inhibitor, within any timeframe prior to the first dose of CT7439.
• •Participants with any other malignancy that have been active or treated within the past 3 years prior to enrolment, with the exception of cervical intraepithelial neoplasia and non-melanoma skin cancer.
• •Any unresolved toxicity (except alopecia) from prior therapy of ≥ 2 Common Terminology Criteria for Adverse Events (CTCAE) Grade.
• •Active or documented history of autoimmune disease.
• •Any current or prior central nervous system metastases
• •Active infection requiring systemic antibiotic, antifungal, or antiviral medication within 14 days prior to first dose of study drug.
• •Severe or uncontrolled medical condition or psychiatric condition.
• •Human immunodeficiency virus (HIV) infection, unless the study participant on anti-retroviral therapy for at least 4 weeks (28 days),and has not had an opportunistic infection within the past 12 months prior to enrollment.
• •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, unless participant with HBV patient is on a suppressive antiviral therapy, or participant with HCV has a viral load below the limit of quantification (LoQ).
• •Participant is breastfeeding or pregnant.
• •Receipt of cytotoxic and/or non- cytotoxic treatment for the malignancy within 28 days before the first dose of IMP.
• •Receipt of corticosteroids within 14 days before the first dose of IMP.
• •Receipt of any small molecule IMP within 28 days or 5 half-lives, whichever is longer, before the first dose of IMP.
• •Receipt of concomitant medication, herbal supplement, or food that is a moderate and/or strong inhibitor or inducer of CYP3A4,,strong inhibitor or inducer of CYP2D6 or P-gp or inhibitor of BCRP within 21 days before the first dose of IMP.
• •Inadequate hepatic, renal and bone marrow function, receipt of a blood transfusion (blood or blood products) within 14 days before the first dose of IMP.
• •Persistent (\> 4 weeks) severe pancytopenia due to previous therapy rather than to disease (ANC \< 0.5 × 109/L or platelets \< 50 x 109/L).
• •History of cardiac dysfunction and/or presence of clinically significant cardiovascular disease
• •Has received a live virus vaccination within 28 days or less of planned treatment start.