Description:
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.
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. Part 2 of this study is randomized (like the flip
of a coin) to receive a specific treatment dose. If someone participates in Part 2, the dose
they receive will be either 100mg twice a day or 150mg twice a day. Every participant in this
study will receive TL-895.
Title
- Brief Title: Phase I/II, First in Human, Dose Escalation Trial of TL 895 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma
- Official Title: Phase I/II, First in Human, Dose Escalation Trial of TL 895 in Subjects With Relapsed/Refractory B-Cell Malignancies and Expansion in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
MS200662_0001
- SECONDARY ID:
2016-000286-23
- NCT ID:
NCT02825836
Conditions
- Relapsed/Refractory B Cell Malignancies
- Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
TL-895 | | TL-895 100 mg BID |
Purpose
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.
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. Part 2 of this study is randomized (like the flip
of a coin) to receive a specific treatment dose. If someone participates in Part 2, the dose
they receive will be either 100mg twice a day or 150mg twice a day. Every participant in this
study will receive TL-895.
Trial Arms
Name | Type | Description | Interventions |
---|
TL-895 80/160 mg QD | Experimental | 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. | |
TL-895 300 mg QD | Experimental | 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. | |
TL-895 600 mg QD | Experimental | 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. | |
TL-895 300 mg BID | Experimental | 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. | |
TL-895 900 mg QD | Experimental | 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. | |
TL-895 100 mg BID | Experimental | Participants received TL-895 100 mg BID orally BID with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study. | |
TL-895 150 mg BID | Experimental | Participants received TL-895 150 mg BID orally BID with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study. | |
Eligibility Criteria
Inclusion Criteria
- Relapsed/refractory CLL or relapsed/refractory SLL
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Part 1 (Dose Escalation): DLTs (Dose Limiting Toxicities) during Cycle 1 |
Time Frame: | Baseline up to the end of cycle 1 (28 days) |
Safety Issue: | |
Description: | DLT is defined as any of the adverse event (AEs) of a certain grade or above, related to drug. |
Secondary Outcome Measures
Measure: | Part 1 (Dose Escalation): Best Overall Response (BOR)/Progression Free Survival (PFS) |
Time Frame: | Baseline up to 6 months on treatment |
Safety Issue: | |
Description: | 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 |
Measure: | Part 2 (Dose Expansion): Overall CR/CRi rate |
Time Frame: | Baseline up to end of study (2 years after last patient enrolled) |
Safety Issue: | |
Description: | The proportion of subjects achieving CR/CRi based on iwCLL response criteria |
Measure: | Part 2: Duration of Clinical Response (DOR) |
Time Frame: | Baseline up to end of study (2 years after last patient enrolled) |
Safety Issue: | |
Description: | Time from initial response to disease progression or death from any cause |
Measure: | Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) |
Time Frame: | Baseline up to end of study (2 years after last patient enrolled) |
Safety Issue: | |
Description: | 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 |
Measure: | Part 2: Assessment of Safety and Tolerability via Clinical Measurements |
Time Frame: | Baseline up to end of study (2 years after last patient enrolled) |
Safety Issue: | |
Description: | Assessments including but not limited to clinical laboratory measurements, ECGs, vital signs, and ECOG performance |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Telios Pharma, Inc. |
Trial Keywords
- TL-895
- Tyrosine Kinase Inhibitor
- Lymphoma
- Open
- Phase I
- Phase II
- CLL
- SLL
Last Updated
August 5, 2021