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

Launched by TELIOS PHARMA, INC. · Jul 1, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TL-895 to see how safe it is and how well it works for patients with certain types of blood cancers, specifically chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The trial has two parts. The first part, which is no longer enrolling participants, focused on finding the best dose of TL-895 for people whose cancer had not responded to previous treatments. The second part of the trial includes different groups of participants who will receive either TL-895 alone or in combination with another drug called navtemadlin. Participants will be randomly assigned to receive either 100 mg or 150 mg of TL-895 twice a day.

To be eligible for this study, participants must have relapsed or refractory CLL/SLL, meaning their cancer returned or did not respond to treatment, or they must be treatment-naïve, meaning they have not received any treatment for their cancer yet. Other requirements include having a good performance status and adequate organ function. Throughout the study, participants will receive TL-895, and the goal is to determine how well it works and what side effects it may cause. It's important to note that individuals who have previously received certain types of cancer treatments or have major health issues may not qualify for this study.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Relapsed/refractory CLL or relapsed/refractory SLL (Arms 1, 2, 5, and 7)
• • Treatment naïve CLL or SLL (Arm 3, 4, and 6)
• • ECOG performance status of ≤ 2
• • Adequate hematologic, hepatic, and renal functions
• • Exclusion Criteria
• • Prior treatment with any BTK or PI3K inhibitors
• • History of major organ transplant
• • Women who are pregnant or breastfeeding