Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-Naïve and R/R CLL/SLL Subjects

Part 1 (Dose Escalation): Best Overall Response (BOR)/Progression Free Survival (PFS)

Defined by the length of time during the treatment of the disease, that a participant lives with the disease but it does not get worse based on investigator assessments

Time frame: Baseline up to 6 months on treatment

Part 2 (Dose Expansion): Overall CR/CRi rate

The proportion of subjects achieving CR/CRi based on iwCLL response criteria

Time frame: Baseline up to end of study (2 years after last patient enrolled)

Part 2: Duration of Clinical Response (DOR)

Time from initial response to disease progression or death from any cause

Time frame: Baseline up to end of study (2 years after last patient enrolled)

Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Incidence, nature, severity of treatment-emergent adverse events (TEAEs), and deaths, including cause of death, from screening up to the end of study visit of participants with CLL/SLL who have failed at least 1 line of therapy

Time frame: Baseline up to end of study (2 years after last patient enrolled)

Part 2: Assessment of Safety and Tolerability via Clinical Measurements

Assessments including but not limited to clinical laboratory measurements, ECGs, vital signs, and ECOG performance

Time frame: Baseline up to end of study (2 years after last patient enrolled)