A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies (NCT02498665) | Clinical Trial Compass
CompletedPhase 1
A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies
United States24 participantsStarted 2015-11
Plain-language summary
This is a multicenter, open label, Phase 1 dose-escalation study of DSP-7888 Dosing Emulsion administered to adult patients with advanced malignancies. Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously in accordance with the following regimen: once weekly for four weeks during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a discontinuation criterion is met during the Maintenance Phase. Once RP2D is determined from either the intradermal or subcutaneous group, an additional 40 patients evaluable for response may be enrolled as an expansion cohort at this dose and route of administration to confirm safety and tolerability. Separate from the dose-ascending cohort and RP2D expansion cohort described previously, and once the intradermal dose-ascending cohort is completed, up to 20 MDS patients who are refractory to treatment with hypomethylating agents (HMAs) will be enrolled into an MDS expansion cohort. Of these 20 MDS patients, one-half will receive DSP-7888 at 10.5 mg according to the modified schedule employed in Phase 1 (every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks; \[MDS Cohort 1\]). The other half of the MDS patients will receive DSP-7888 at 10.5 mg in an alternative dosing schedule where DSP-7888 is administered every 2 weeks until Week 24, after which it will be administered every 4 weeks (MDS Cohort 2).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
✓. Patient has one of the following histologically or cytologically confirmed advanced malignancies: acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), glioblastoma multiforme (GBM), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, sarcoma, renal cell carcinoma (RCC)
✓. Patient must meet at least one of the following criteria: a. Progressed or recurrent despite standard therapy, b. No standard therapy exists for this malignancy, c. Patient is intolerant of standard therapy, d. Patient is not a candidate for standard therapy, e. For AML and MDS patients: patient is not a candidate for allogeneic hematopoietic stem cell transplantation, f, For sarcoma patients: f-1. Patient has disease that is metastatic or unresectable, f-2. Patient with metastatic disease has had at least one prior line of therapy for metastatic disease, f-3. No curative multimodality options exist
✓. Patients must be positive for at least one of the following human leukocyte antigens (HLA): a. HLA-A\*02:01, b. HLA-A\*02:06, c. HLA-A\*24:02
✓. ≥ 18 years of age
✓. For patients with solid tumors, one of the following must apply: a. Patient has measurable disease as defined by the immune-related response criteria (irRC), b. Patient has ovarian cancer and has disease evaluable by CA-125 only
What they're measuring
1
Determination of the safety and tolerability of DSP-7888 Dosing Emulsion by assessing dose-limiting toxicities (DLTs)
Timeframe: 4 weeks
2
Determination of the safety and tolerability of DSP-7888 Dosing Emulsion by assessing duration of study treatment
Timeframe: 12 months
3
Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs)
✓. For patients with solid tumors, the following criteria apply: a. Hemoglobin ≥ 9.0 g/dl, b. Absolute lymphocyte count ≥ 1.0 x 10\^9/L, c. Absolute neutrophil count ≥ 1.5 x 10\^9/L, d. Platelets ≥ 100.0 x 10\^9/L
✓. Patients with MDS must have been diagnosed as MDS by WHO (4th edition) or French-American-British (FAB) classification
Exclusion criteria
✕. Patient has an extensively disseminated primary glioblastoma
✕. Patient has acute promyelocytic leukemia (APML)
✕. For AML and MDS patients: patients with a dry tap on bone marrow aspiration during screening
✕. Patient has symptomatic brain metastases (i.e., metastases that are accompanied by neurological symptoms or that require treatment with corticosteroids)
✕. Patient has an infection requiring treatment with systemic antibiotics or antiviral medication or has completed treatment for such an infection within 14 days prior to planned first dose of study drug
✕. Patient requires systemic, pharmacologic doses of corticosteroids (equivalent to \>30 mg hydrocortisone/day) Note: Replacement doses (equivalent to ≤ 5 mg prednisone/day), and topical, ophthalmic, and inhalation steroids are permitted as needed
✕. Patient has a positive test for Hepatitis B surface antigen, Hepatitis C antibody, human immunodeficiency virus HIV-1 or HIV-2 antibody, or has a history of a positive result for hepatitis C virus (HCV) or HIV
✕. Patient has received any of the following treatments within the specified timeframes: a. Surgery, radiotherapy, chemotherapy (including molecular-targeted drugs): 4 weeks (28 days), b. Immunosuppressants or cytokine formulations (excluding G-CSF): 4 weeks (28 days), c. Endocrine therapy or immunotherapy (including biological response modifier therapy): 2 weeks (14 days)