A Phase 1a/1b Dose-Escalation and Expansion Trial of TTI-622 in Patients With Advanced Hematologic Malignancies, Including Lymphoma, Leukemia, and Multiple Myeloma
Description
Brief 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.
Detailed 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.
Phase
N/AInclusion and Exclusion Criteria
- Key Inclusion Criteria (Phase 1a and Phase 1b, all Cohorts):
- Available fresh or archived tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Adequate coagulation function.
- Adequate hepatic function.
- Adequate hematologic status.
- Adequate renal function.
- Recovery from non-hematopoietic toxicities of previous anticancer drugs or radiotherapy or previous surgeries to ≤Grade 1 (or to baseline grade if condition was pre-existing). Key Inclusion Criteria (Phase 1a): Histologically confirmed relapsed/refractory lymphoma (Hodgkin or non-Hodgkin). Key Inclusion Criteria (Phase 1b Cohort A): Histologically confirmed, newly diagnosed TP53-mutated Acute Myeloid Leukemia (AML). Key Inclusion Criteria (Phase 1b Cohort B): Histologically confirmed, newly diagnosed TP53-wildtype AML, elderly or unfit for more aggressive treatment. Key Inclusion Criteria (Phase 1b Cohorts C and E): Histologically documented relapsed/refractory Multiple Myeloma (MM). Key Inclusion Criteria (Phase 1b Cohort D): Pathologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) Key Exclusion Criteria (Phase 1a and Phase 1b, all Cohorts):
- Known, current central nervous system disease involvement.
- Use of any investigational agent or any anticancer drug within 14 days before planned start of study treatment (within 4 weeks for antibody-based therapies and within 8 weeks for cell-based therapies).
- Subjects who have undergone radiation therapy within 14 days of study treatment administration.
- Hematopoietic stem cell transplant within 90 days before the planned start of study treatment or subjects with active graft-vs-host disease, with the exception of Grade 1 skin involvement.
- Major surgery within 30 days before planned start of study treatment.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.