A Phase I/II Study of TTI-621 in Combination with Doxorubicin in Patients with Unresectable or Metastatic High-Grade Leiomyosarcoma
Multi-center, open-label, Phase I/II dose escalation and expansion trial of TTI-621 in patients with unresectable or metastatic high-grade leiomyosarcoma.
* 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
* 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
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.
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.
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.
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