A Trial of TTI-622 in Patients With Advanced Hematologic Malignancies (TTI-622-01)
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- STATUS
- Recruiting
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- End date
- Jun 30, 2024
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- participants needed
- 350
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- sponsor
- Trillium Therapeutics Inc.
Summary
Multicenter, open-label, phase 1a/1b Dose Escalation and Expansion Trial of TTI-622 in subjects with Advanced Hematologic Malignancies, Including Lymphoma, Leukemia, and Multiple Myeloma.
Description
This is a trial of TTI-622 in subjects with relapsed or refractory lymphoma or multiple myeloma (MM) and subjects with newly diagnosed acute myeloid leukemia (AML).
This trial will be conducted in 2 phases: Phase 1a (Dose-Escalation Phase for Single-Agent TTI-622) and Phase 1b (TTI-622 Combinations and Single-Agent).
In the Dose-Escalation Phase for Single-Agent TTI-622, subjects with relapsed or refractory lymphoma will be enrolled in sequential dose cohorts.
In the Combination and Single-Agent Treatment part, subjects will be included in 1 of 9 cohorts: (Cohort A) subjects with newly diagnosed TP53-mutated AML will be treated with TTI-622 + azacitidine; (Cohort B) elderly subjects (≥75 years old) or subjects unfit for intensive induction chemotherapies with newly diagnosed TP53-wildtype AML will be treated with TTI-622 + azacitidine and venetoclax; (Cohort C1, C2, and C3) subjects with relapsed or refractory MM will be treated with TTI-622 + carfilzomib and dexamethasone; (Cohort D1 and D2) subjects in relapsed or refractory CD20+ diffuse large B-cell lymphoma will be treated with TTI-622 + an anti-CD20 targeting agent; and (Cohort E1 and E2) subjects with relapsed refractory MM will be treated with single-agent TTI-622.
Details
| Condition | Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, Diffuse Large B-Cell Lymphoma |
|---|---|
| Treatment | Dexamethasone, Azacitidine, Carfilzomib, venetoclax, TTI-622 Monotherapy, TTI-622 + Rituximab, TTI-622 + PD-1/PD-L1 Inhibitor, TTI-622 + Proteasome-inhibitor Regimen, TTI-622 + PD-1 Inhibitor, TTI-622, anti-CD20 Targeting agent |
| Clinical Study Identifier | NCT03530683 |
| Sponsor | Trillium Therapeutics Inc. |
| Last Modified on | 8 June 2022 |
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