A Trial of TTI-621 in Combination With Doxorubicin in Patients With Leiomyosarcoma

Overview

About this study

The purpose of this study to evaluate TTI-621 combined with Doxorubicin in patients with unresectable or metastatic high-grade leiomyosarcoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

2. Histologically-confirmed high-grade soft tissue sarcoma that is metastatic or locally
advanced and not amenable to curative treatment with surgery or radiation.

1. In the Dose Escalation phase, indications will be limited to high-grade
leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma,
dedifferentiated liposarcoma, angiosarcoma and epithelioid sarcoma

2. In the Dose Expansion phase, indications will be limited to high-grade
leiomyosarcoma.

3. Objective evidence of disease progression unless disease is newly-diagnosed.

4. Measurable disease per RECIST v1.1 (expansion cohorts).

5. Adequate organ and hematologic function.

6. No more than 1 prior treatment regimen for advanced disease, which is limited to
gemcitabine with docetaxel.

7. Anthracycline-naïve.

8. Patients who were treated with a prior chemotherapy regimen must have completed
treatment at least three weeks before initiation of study treatment.

9. All adverse events from prior treatment must be NCI CTCAE v5 Grade ≤ 1, except
alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.

10. Radiotherapy, including palliative radiotherapy, completed at least two weeks prior to
treatment; palliative radiation to non-target lesions while on study is allowed.

Key Exclusion Criteria:

1. History of acute coronary syndromes.

2. History of or current Class II, III, or IV heart failure.

3. History or evidence of known CNS metastases or carcinomatous meningitis.

4. Significant bleeding disorders, vasculitis or a significant bleeding episode from the
GI tract.

5. History of severe hypersensitivity reactions to antibodies.

6. Systemic steroid therapy.

7. History or autoimmune disease that has required systemic treatment with
disease-modifying agents, corticosteroids, or immunosuppressive drugs.

8. Prior organ transplantation including allogenic or autologous stem cell
transplantation

9. Prior treatment with anti-CD47 or anti-SIRP? therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/4/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Attia, D.O.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions