A Trial of TTI-622 in Patients With Advanced Hematologic Malignancies

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trillium Therapeutics Inc.
• Treatments: Azacitidine; Dexamethasone; Immunoglobulin G; Proteasome Inhibitors; Rituximab; Venetoclax

Criteria

Key Inclusion Criteria (Phase 1a and Phase 1b, all Cohorts):

1. Available fresh or archived tumor tissue.

2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.

3. Adequate coagulation function.

4. Adequate hepatic function.

5. Adequate hematologic status.

6. Adequate renal function.

7. 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.

Inclusion Criteria (Phase 1b Cohort C): Histologically documented relapsed/refractory Multiple Myeloma (MM).

Key Exclusion Criteria (Phase 1a and Phase 1b, all Cohorts):

1. Known, current central nervous system disease involvement.

2. 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).

3. Subjects who have undergone radiation therapy within 14 days of study treatment administration.

4. 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.

5. Major surgery within 30 days before planned start of study treatment.