TL-895 + Navtemadlin for Chronic Lymphocytic Leukemia

Recruiting at 16 trial locations

Overseen By Nikki Stuart

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Telios Pharma, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants. Arms 1 \& 2 of Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Arms 1 \& 2 of Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in arms 1 or 2 of Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. Arms 3 and 4 of Part 2 of this study will test the 150mg and 100mg BID dose of TL-895, respectively in treatment naïve participants with CLL/SLL. Arms 5 and 6 of Part 2 will test 150mg TL-895 BID in combination with 240 mg navtemadlin QD in participants with relapsed/refractory and treatment naïve without 17p(del). Arm 7 will test 150mg TL-895 in combination with 240 mg navtemadlin QD in participants with relapsed/refractory CLL/SLL with 17p(del). Every participant in this study will receive TL-895.

Eligibility Criteria

This trial is for adults with certain types of blood cancers like CLL or SLL who have either not been treated before (treatment naïve) or whose disease came back after treatment (relapsed/refractory). They should be relatively active and able to care for themselves, with their major organs working well. Pregnant women, breastfeeding mothers, those who've had organ transplants, or previous treatments with BTK/PI3K inhibitors can't join.

Inclusion Criteria

My blood, liver, and kidney functions are all within normal ranges.

I have not received any treatment for my CLL or SLL.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I am not pregnant or breastfeeding.

I have had a major organ transplant.

I have been treated with BTK or PI3K inhibitors before.

Treatment Details

Interventions

• Navtemadlin (Other)
• TL-895 (Other)

Trial Overview The study tests the safety and best dose of a drug called TL-895 alone and in combination with Navtemadlin. Participants are randomly assigned to receive different doses of TL-895 twice daily. Some will also get Navtemadlin once daily if they haven't responded to prior therapies or if they're new patients without a specific genetic change (17p deletion).

Participant Groups

Group I: TL-895 900 mg QD in R/R Participants Experimental Treatment 1 Intervention

Participants received TL-895 900 mg PiC orally QD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group II: TL-895 80/160 mg QD in R/R Participants Experimental Treatment 1 Intervention

Participants received TL-895 80 mg powder in capsule (PiC) orally once daily (OD) for 3 days followed by TL-895 160 mg OD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group III: TL-895 600 mg QD in R/R Participants Experimental Treatment 1 Intervention

Participants received TL-895 600 mg PiC orally OD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group IV: TL-895 300 mg QD in R/R Participants Experimental Treatment 1 Intervention

Participants received TL-895 300 mg PiC orally OD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group V: TL-895 300 mg BID in R/R Participants Experimental Treatment 1 Intervention

Participants received TL-895 300 mg PiC orally twice daily (BID) in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group VI: TL-895 150 mg BID in Treatment Naïve Participants Experimental Treatment 1 Intervention

Participants received TL-895 150 mg BID orally with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group VII: TL-895 150 mg BID in R/R Participants Experimental Treatment 1 Intervention

Participants received TL-895 150 mg BID orally with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group VIII: TL-895 150 mg BID & navtemadlin 240mg QD in Treatment Naïve Participants without 17p(del) Experimental Treatment 2 Interventions

Participants received navtemadlin 240 mg administered QD on Days 1-7 in combination with TL-895 150 mg BID orally with food for 28 days with in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group IX: TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants without 17p(del) Experimental Treatment 2 Interventions

Participants received navtemadlin 240 mg administered QD on Days 1-7 in combination with TL-895 150 mg BID orally with food for 28 days with in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group X: TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants with 17p(del) Experimental Treatment 2 Interventions

Participants received navtemadlin 240 mg administered QD on Days 1-7 in combination with TL-895 150 mg BID orally with food for 28 days with in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group XI: TL-895 100 mg BID in Treatment Naïve Participants Experimental Treatment 1 Intervention

Participants received TL-895 100 mg BID orally with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Group XII: TL-895 100 mg BID in R/R Participants Experimental Treatment 1 Intervention

Participants received TL-895 100 mg BID orally with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.

Who Is Running the Clinical Trial?

Telios Pharma, Inc.

Lead Sponsor

Trials

11

Recruited

1,700+