Clinical Trial 21728

• Overview

  Study Title:

  A Phase I/II Study of TTI-621 in Combination with Doxorubicin in Patients with Unresectable or Metastatic High-Grade Leiomyosarcoma

  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.

  Objective:

  Primary Objectives * Evaluate the safety of escalating dose levels of TTI-621 when administered in combination with 75 mg/m2 doxorubicin in 21-day cycles and establish the maximum tolerated dose level of TTI-621 when administered in combination with doxorubicin * Evaluate the safety of selected dose levels of TTI-621 when administered in combination with 75 mg/m2 doxorubicin in 21-day cycles and then as monotherapy in 28-day cycles until documentation of objective disease progression * Investigate clinical activity assessed as overall response rate of TTI-621 administered in combination with 75 mg/m2 doxorubicin for up to six cycles (18 weeks) and then as monotherapy until documentation of objective disease progression Secondary Objectives * Further assess safety of the selected dose levels of TTI-621 administered in combination with 75 mg/m2 doxorubicin * Describe other evidence of clinical benefit

• Treatments

  Therapies:

  Chemotherapy (NOS); Radiotherapy

  Medications:

  Adriamycin (doxorubicin); TTI-621 (); doxorubicin ()

• Inclusion Criteria

  Key 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. a. In the Dose Escalation phase, indications will be limited to high-grade leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma and epithelioid sarcoma b. In the Dose Expansion phase, indications will be limited to high-grade leiomyosarcoma. The patient may be enrolled based on a current or most recent pathology report that provides sufficient detail to support derivation of the histologic interpretation but a pre-treatment tissue specimen must be made available for confirmation during screening or within the first cycle of treatment
  • 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 > 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

  Key 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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