A Trial of TTI-622 in Patients With Advanced Hematologic Malignancies (TTI-622-01)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    350
  • sponsor
    Trillium Therapeutics Inc.
Updated on 8 June 2022
cancer
hematologic malignancy
lymphoma
multiple myeloma
rituximab
leukemia
dexamethasone
azacitidine
venetoclax
TP53
nivolumab
diffuse large b-cell lymphoma
b-cell lymphoma
carfilzomib
refractory lymphoma
large b-cell lymphoma
refractory multiple myeloma

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 IdentifierNCT03530683
SponsorTrillium Therapeutics Inc.
Last Modified on8 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Available fresh or archived tumor tissue
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Adequate hematologic status
Adequate coagulation function
Adequate hepatic function
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)

Exclusion Criteria

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
Major surgery within 30 days before planned start 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note