Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas (NCT04242238) | Clinical Trial Compass
CompletedPhase 1
Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas
United States32 participantsStarted 2020-01-22
Plain-language summary
This study is being done to find the safest dose of DCC-3014 that can be given with avelumab to participants with advanced or metastatic sarcomas that will not cause serious side effects.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age \>/= 18 years at the time of informed consent
* Be capable, willing, and able to provide written informed consent/assent
* Be willing to comply with clinical trial instructions and requirement, including mandatory biopsies
* Dose escalation phase: Patients must have a histologically confirmed metastatic and/or locally advanced high grade sarcoma
* Dose expansion phase: Patients must have a histologically confirmed metastatic and/or locally undifferentiated pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, or dedifferentiated liposarcoma
* Adequate performance status: ECOG 0 or 1/KPS 100-70%
* Patients must have at least one prior line of systemic therapy (e.g. chemotherapy, targeted or biological therapy) for their sarcoma. Prior neoadjuvant and/or adjuvant therapy will count regardless of when it was completed. Treatment naïve patients can enroll if they refuse standard of care systemic chemotherapy.
* Presence of measurable disease per RECIST v1.1. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment
* Adequate organ function determined within 28 days of treatment initiation, as defined in Table 3:
Table 3: Laboratory values inclusion criteria
Hematological Absolute neutrophil count (ANC): ≥1,500 / mcL Platelets: ≥ 100,000 / mcL Hemoglobin: ≥ 9 g/dL or ≥ 5.6 mmol/L
Renal
Serum Creatinine OR Measured …