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

  • STATUS
    Recruiting
  • End date
    Jan 4, 2024
  • participants needed
    80
  • sponsor
    Pfizer
Updated on 4 October 2022
measurable disease
doxorubicin
gemcitabine
docetaxel
cancer chemotherapy
angiosarcoma
soft tissue sarcoma
liposarcoma
undifferentiated pleomorphic sarcoma
leiomyosarcoma
epithelioid sarcoma

Summary

Multi-center, open-label, Phase I/II dose escalation and expansion trial of TTI-621 in patients with unresectable or metastatic high-grade leiomyosarcoma.

Description

This trial will be conducted in 2 phases: Phase I (Dose Escalation of TTI-621 in combination with doxorubicin) and Phase II (Dose Expansion of TTI-621 in combination with doxorubicin).

Phase I (Dose Escalation of TTI-621 in combination with doxorubicin) will enroll patients with soft-tissue sarcomas including leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma or epithelioid sarcoma

Phase II (Dose Expansion of TTI-621 in combination with doxorubicin) will include 2 cohorts: Cohort A and Cohort B. The lower selected dose of TTI-621 will be studied in Cohort A while the higher dose of TTI-621 will be studied in Cohort B. Patients with leiomyosarcoma will be enrolled.

Details
Condition Leiomyosarcoma
Treatment doxorubicin, TTI-621
Clinical Study IdentifierNCT04996004
SponsorPfizer
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Histologically-confirmed high-grade soft tissue sarcoma that is metastatic or locally advanced and not amenable to curative treatment with surgery or radiation
In the Dose Escalation phase, indications will be limited to high-grade leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma and epithelioid sarcoma
In the Dose Expansion phase, indications will be limited to high-grade leiomyosarcoma
Objective evidence of disease progression unless disease is newly-diagnosed
Measurable disease per RECIST v1.1 (expansion cohorts)
Adequate organ and hematologic function
No more than 1 prior treatment regimen for advanced disease, which is limited to gemcitabine with docetaxel
Anthracycline-naïve
Patients who were treated with a prior chemotherapy regimen must have completed treatment at least three weeks before initiation of study treatment
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
Radiotherapy, including palliative radiotherapy, completed at least two weeks prior to treatment; palliative radiation to non-target lesions while on study is allowed

Exclusion Criteria

History of acute coronary syndromes
History of or current Class II, III, or IV heart failure
History or evidence of known CNS metastases or carcinomatous meningitis
Significant bleeding disorders, vasculitis or a significant bleeding episode from the GI tract
History of severe hypersensitivity reactions to antibodies
Systemic steroid therapy
History or autoimmune disease that has required systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs
Prior organ transplantation including allogenic or autologous stem cell transplantation
Prior treatment with anti-CD47 or anti-SIRPα therapy
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