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Phase I/II, First in Human, Dose Escalation Trial of TL-895 Monotherapy in Subjects with Relapsed/Refractory B-Cell Malignancies and Expansion of TL-895 Monotherapy and Combination Therapy with Navtemadlin in Treatment-Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Subjects and Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma
EU CTIS ID: 2024-516691-14-00
What this study is testing
For dose expansion, Part 2: Arms 1, 2, 3 and 4 To determine the overall response rate (ORR) based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) response criteria per Investigator assessment Arms 5, 6 and 7 To determine the ORR based on iwCLL response criteria per Investigator assessment
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults ≥18 years of age
- Arms 1 and 2 - Subject population (relapsed/refractory CLL or relapsed/refractory SLL)
- Arms 3 and 4 - Subject population (treatment-naive CLL or treatment-naïve SLL)
- Arm 5 - Subject population (relapsed/refractory CLL or relapsed/refractory SLL)
- Arm 6 - Subject population (treatment-naive CLL or treatment-naïve SLL)
- Arm 7 - Subject population (relapsed/refractory CLL or relapsed/refractory SLL)
You likely can't join if
- 1. Prior anticancer treatment with any BTK, MDM2 inhibitor or PI3K inhibitor
- 18. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.
- 2. Known history of central nervous system lymphoma or leukemia
- 20. Women who are pregnant or breastfeeding.
- 3. History of Richter’s transformation or prolymphocytic leukemia
- 4. Arms 1, 2, 5 and 7 - Prior therapy with: • Anticancer treatment with chemotherapy, immunomodulating therapy, biologic therapy, radiation therapy, or with any other anticancer therapy within 28 days prior to first dose of study treatment. • Any investigational agent within 28 days prior to first dose of study treatment. Participation in observational study is permitted. • Allogeneic stem cell transplant or active graft versus host disease following allogeneic transplant within 6 months prior to first dose of study treatment. • Autologous stem cell transplant within the last 3 months prior to first dose of study treatment
See the full eligibility criteria
Who can join
- Adults ≥18 years of age
- Arms 1 and 2 - Subject population (relapsed/refractory CLL or relapsed/refractory SLL)
- Arms 3 and 4 - Subject population (treatment-naive CLL or treatment-naïve SLL)
- Arm 5 - Subject population (relapsed/refractory CLL or relapsed/refractory SLL)
- Arm 6 - Subject population (treatment-naive CLL or treatment-naïve SLL)
- Arm 7 - Subject population (relapsed/refractory CLL or relapsed/refractory SLL)
- For the full list of inclusion criteria please refer to the Protocol
What rules you out
- 1. Prior anticancer treatment with any BTK, MDM2 inhibitor or PI3K inhibitor
- 18. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.
- 2. Known history of central nervous system lymphoma or leukemia
- 20. Women who are pregnant or breastfeeding.
- 3. History of Richter’s transformation or prolymphocytic leukemia
- 4. Arms 1, 2, 5 and 7 - Prior therapy with: • Anticancer treatment with chemotherapy, immunomodulating therapy, biologic therapy, radiation therapy, or with any other anticancer therapy within 28 days prior to first dose of study treatment. • Any investigational agent within 28 days prior to first dose of study treatment. Participation in observational study is permitted. • Allogeneic stem cell transplant or active graft versus host disease following allogeneic transplant within 6 months prior to first dose of study treatment. • Autologous stem cell transplant within the last 3 months prior to first dose of study treatment
- 5. Arms 3, 4 and 6 – Any prior therapy used for treatment of CLL/SLL
- 8. Received major surgical intervention within 28 days prior to first dose of study treatment, or history of major organ transplant.
- 9. Subjects with active fever (temperature higher than 38.2°C [100.8°F]) within 14 days prior to the first dose of study treatment
- For the full list of exclusion criteria please refer to the Protocol
- 10. Subjects with indwelling surgical drains (e.g., peritoneal, CNS, or pleural)
- 11. Having history of difficulty of swallowing, gastric or small bowel surgery with history of malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study treatment.
- 12. Uncontrolled intercurrent illness including, but not limited to clinically significant cardiac disease (New York Heart Association Class III or IV); symptomatic congestive heart failure; unstable angina pectoris; unstable ventricular arrhythmia; or psychiatric illness/ social situations that would limit compliance with study requirements.
- 13. Grade 2 or higher QTc prolongation (> 480 milliseconds per National Cancer Institute Common Terminology of Adverse Events [v 5.0]).
- 14. Subjects with uncontrolled bacterial, fungal, parasitic, or viral infection. Subjects with acute bacterial infections requiring antibiotic use should not enroll until the infection is stable in the judgement of the treating physician; these subjects may be on antibiotics at time of screening
- 15. Subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV)
- 16. Subjects with known history of human immunodeficiency virus (HIV)
- 17. Other malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with normal prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma.
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ukraine. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.