Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Neoplasm Metastasis

Stomach Neoplasms

Pancreatic Neoplasms

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Wilms Tumor

Neoplastic Processes

Stomach Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Wilms' Tumor

CUE-102 (1 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

CUE-102 (2 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

CUE-102 (4 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

CUE-102 (8 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

Dose expansion of CUE-102 at determined RP2D Monotherapy IV infusion every 3 weeks for up to 2 years

CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.

CUE-102

Steven Margossian, M.D., Ph.D.

Reena Lynam

Bekaii Saab

Katherine Eckert

Lauren Ponto

Katie Coleman

Lei Zheng, M.D, PhD

Preston Buechler

Zhaohui Jin

Amanda Hall

Christopher Chen

Gunnar Lauer

Ashley Wallace

John Powderly, M.D.

Carrie Smith

Nashat Gabrail, M.D.

UH SCC Cancer Information Services

Jing Peng

Sue Quinsey

Cancer Connect

Matteo Levisetti, MD

This is a Phase 1, open-label, 2-part, multi-center study evaluating the safety, tolerability, PK, pharmacodynamics (PD), immunogenicity, and antitumor activity of CUE-102 intravenous (IV) monotherapy in HLA-A\*0201 positive patients with WT1 positive recurrent/metastatic solid tumors who have failed conventional therapies.

CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies by selective engagement and expansion of tumor antigen-specific T cells that should allow for increased potential for anti-cancer efficacy and reduced toxicity relative to non-targeted forms of immunotherapy that result in systemic activation of the immune system.

The goal of Part A is to characterize the safety, tolerability, and biological effects of CUE-102.

The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A, and to evaluate antitumor activity at this dose.

A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers

A Phase 1, Open-Label, Dose Escalation and Expansion Study of CUE-102 Monotherapy in HLA-A*0201 Positive Patients With WT1 Positive Recurrent/Metastatic Cancers

Evaluate dose-limiting toxicities (DLTs) during the first cycle of treatment with CUE-102, and to establish a recommended Phase 2 dose (RP2D)

Evaluate maximum tolerated dose (MTD) to establish a recommended Phase 2 dose (RP2D)

Area under the concentration-time curve (AUC) of CUE-102.

Maximum serum concentration (Cmax) of CUE-102.

To evaluate safety and tolerability of CUE-102 using NCI CTCAE v5.0.

To evaluate antitumor response rate of CUE-102 by RECIST 1.1

To evaluate antitumor duration of response of CUE-102 by RECIST 1.1

To evaluate antitumor clinical benefit rate of CUE-102 by RECIST 1.1

To evaluate antitumor progression-free survival of CUE-102 by RECIST 1.1

To evaluate overall survival after treatment with CUE-102

To evaluate the potential for immune response after treatment with CUE-102 using assessment of number of WT1 tetramer-positive T cell lymphocytes.

To evaluate the potential for immune response after treatment with CUE-102 using assessment of cytotoxic T lymphocyte (CTL) markers of activation

Cue Biopharma

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Skin and Connective Tissue Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Syndrome

Leukemia

Melanoma

Carcinoma, Renal Cell

Glioblastoma

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Sarcoma

Preleukemia

Myelodysplastic Syndromes

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Hematologic Diseases

Bone Marrow Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Myeloid Leukemia

Acute Myeloid Leukemia

Renal Cell Carcinoma

Acute Non Lymphoblastic Leukemia

Clear Cell Renal Cell Carcinoma

Soft Tissue Sarcoma

Acute Graft Versus Host Disease

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously. Dose-escalation will proceed according to the Criteria for Dose Escalation and Criteria for Determination of Dose-Limiting Toxicity (DLT) as indicated below. Dose Level I: 3.5 mg, Dose Level II: 10.5 mg, Dose Level III: 17.5 mg

Patients will be intradermally administered of DSP-7888 at 10.5 mg every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks.

Patients will be intradermally administered of DSP-7888 at 10.5 mg every 2 weeks until Week 24, and then every 4 weeks.

Dose escalation cohort: 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.

MDS cohort 1: Patients will be intradermally administered of DSP-7888 at 10.5 mg every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks.

MDS cohort 2: Patients will be intradermally administered of DSP-7888 at 10.5 mg every 2 weeks until Week 24, and then every 4 weeks.

DSP-7888 Dosing Emulsion

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).

A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies

A Phase I Clinical Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies

Evaluation of anti-tumor activity will be performed according to Immune Related Response Criteria (irRC) for solid tumors. For patients with ovarian cancer who have disease at baseline that is evaluable by CA-125 criteria only, the Gynecologic Cancer Intergroup (GCIG) criteria will be used for response assessment. For patients with AML, response assessment will be performed according to the AML International Working Group (IWG) criteria.

Cytotoxic T lymphocyte induction, histopathology and Reverse transcription polymerase chain reaction (RT-PCR) assays will be performed to provide information of the biomarkers on biopsied patient tumor tissue, archival samples and peripheral blood samples.

Sumitomo Pharma America, Inc.

Precancerous Conditions

Antineoplastic Agents

Decitabine

Antimetabolites

Enzyme Inhibitors

36 mg/m2 on day 42 after transplantation and administered daily for 5 consecutive days every 28 days for up to a total of 10 cycles

decitabine

Fu chengcheng, Phd

Allo - hematopoietic stem cell transplantation is currently the only way to cure myelodysplastic syndrome /acute leukemia . The existing experimental results showed that decitabine and 5-azacytidine up-regulated the expression of tumor Ags on leukemic blasts in vitro and expanded the numbers of immunomodulatory T regulatory cells in animal models. Reasoning that decitabine might selectively augment a graft versus leukemia effect, the investigators used decitabine administration after allogeneic stem cell transplantation to studied the immunologic sequelae.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers	NCT05360680	Colorectal Canc... Gastric Cancer Pancreatic Canc... Ovarian Cancer	CUE-102	18 Years -	Cue Biopharma
A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies	NCT02498665	Acute Myeloid L... Myelodysplastic... Glioblastoma Mu... Melanoma Non-Small Cell ... Ovarian Cancer Pancreatic Canc... Sarcoma Renal Cell Carc...	DSP-7888 Dosing...	18 Years -	Sumitomo Pharma America, Inc.
Decitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome	NCT01809392	Acute Myelocyti... Myelodysplastic...	decitabine	18 Years - 55 Years	The First Affiliated Hospital of Soochow University

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