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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/A

Inclusion 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

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