A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-622 in Patients With Advanced Relapsed or Refractory Lymphoma or Myeloma

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

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.

Additional Trial Information

Phase 1

Enrollment: 476 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

USC Norris Comprehensive Cancer Center University of Southern California

Los Angeles, CA

Open and Accepting

Colorado

Georgia

Northside Hospital (Atlanta)

Atlanta, GA

Open and Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, MI

Open and Accepting

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

Tennessee

University of Tennessee Medical Center Cancer Institute

Knoxville, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Washington

Swedish - Cherry Hill Campus Cherry Hill Campus

Seattle, WA

Open and Accepting

Washington, D.C.

Georgetown Lombardi Comprehensive Cancer Center Georgetown University

Washington, DC

Open and Accepting
Interested in this trial?
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