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TL-895 + Navtemadlin for Chronic Lymphocytic Leukemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Telios Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatment naïve CLL or SLL for Arm 3, 4, and 6

ECOG performance status of ≤ 2

Must not have

Women who are pregnant or breastfeeding

History of major organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to end of study (2 years after last patient enrolled)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, TL-895, to see if it is safe and tolerable for people with relapsed or refractory B cell malignancies who have failed one to three prior therapies. The trial has two parts; the first part has already completed testing and the second part is currently enrolling participants. The second part of the trial will test different doses of TL-895 on two groups of people: those who have failed at least one prior therapy, and those who have not received any prior therapy. Every participant in the study will receive TL-895.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Specific side effects aren't listed here but generally could include issues related to how the body tolerates the drugs such as nausea, fatigue, allergic reactions, liver problems, changes in blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have had a major organ transplant.

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I have been treated with BTK or PI3K inhibitors before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to end of study (2 years after last patient enrolled)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to end of study (2 years after last patient enrolled)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of study (2 years after last patient enrolled) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 (Dose Escalation): DLTs (Dose Limiting Toxicities) during Cycle 1

Part 2 (Dose Expansion): Overall Response Rate (ORR)

Secondary study objectives

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

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

Part 2: Assessment of Safety and Tolerability via Clinical Measurements

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

12Treatment groups

Experimental Treatment

Group I: TL-895 900 mg QD in R/R ParticipantsExperimental Treatment1 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 ParticipantsExperimental Treatment1 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 ParticipantsExperimental Treatment1 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 ParticipantsExperimental Treatment1 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 ParticipantsExperimental Treatment1 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 ParticipantsExperimental Treatment1 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 ParticipantsExperimental Treatment1 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 Treatment2 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 Treatment2 Interventions

Group X: TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants with 17p(del)Experimental Treatment2 Interventions

Group XI: TL-895 100 mg BID in Treatment Naïve ParticipantsExperimental Treatment1 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 ParticipantsExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TL-895

2020

Completed Phase 1

~10

0 / 5Eligibility criteria met