Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose
(RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with
investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable,
advanced, well-differentiated, somatostatin receptor expressing (SSTR+)
gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following
treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as
177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.
(RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with
investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable,
advanced, well-differentiated, somatostatin receptor expressing (SSTR+)
gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following
treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as
177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.
Not Available
I/III
Not Available
NCT05477576
VICCGIP2209
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound
that targets both EGFR with TGF. Based on preclinical data, this bifunctional antibody may
exert synergistic activity in patients with EGFR-driven tumors.
that targets both EGFR with TGF. Based on preclinical data, this bifunctional antibody may
exert synergistic activity in patients with EGFR-driven tumors.
Not Available
I
Choe, Jennifer
NCT04429542
VICCPHI2254
A Study of SNDX-5613 in Combination with Chemotherapy for Patients Diagnosed with Relapsed or Refractory Leukemia
This phase II trial tests the safety and best dose of SNDX-5613 (revumenib) in combination with chemotherapy, and evaluates whether this treatment improves the outcome in infants and young children who have leukemia that has come back (relapsed) or does not respond to treatment (refractory) and is associated with a KMT2A (MLL) gene rearrangement (KMT2A-R). Leukemia is a cancer of the white blood cells, where too many underdeveloped (abnormal) white blood cells, called blasts, are found in the bone marrow, which is the soft, spongy center of the bones that produces the three major blood cells: white blood cells to fight infection; red blood cells that carry oxygen; and platelets that help blood clot and stop bleeding. The blasts crowd out the normal blood cells in the bone marrow and spread to the blood. They can also spread to the brain, spinal cord, and/or other organs of the body. The leukemia cells of some children have a genetic change in which a gene (KMT2A) is broken and combined with other genes that typically do not interact with one another; this is called rearranged. This genetic rearrangement alters how other genes are turned on or off in the cell, turning on genes that drive the development of leukemia. Patients with KMT2A rearrangement have higher risk for cancer coming back after treatment. Revumenib is an oral medicine that directly targets the changes that occur in a cell with a KMT2A rearrangement and has been shown to specifically kill these leukemia cells in preclinical laboratory settings and in animals. Drugs used in chemotherapy, such as vincristine, prednisone, asparaginase, fludarabine and cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial is being done to find out if the combination of revumenib and chemotherapy would be safe and/or effective in treating infants and young children with relapsed or refractory KMT2A-R leukemia.
Not Available
II
Smith, Brianna
NCT05761171
VICC-NTPED23556
Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial
This phase II clinical trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumors DNA.
Not Available
II
Choe, Jennifer
NCT05554367
ECOGMDEAY191-A3
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus
standard of care (SOC) in first-line therapy in participants with high-risk large B-cell
lymphoma.
standard of care (SOC) in first-line therapy in participants with high-risk large B-cell
lymphoma.
Not Available
III
Jallouk, Andrew
NCT05605899
VICCCTT2298
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
The purpose of this study is to find out whether the study drug, LY3537982, is safe and
effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must
have already received or were not able to tolerate the standard of care, except for specific
groups who have not had cancer treatment. The study will last up to approximately 4 years.
effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must
have already received or were not able to tolerate the standard of care, except for specific
groups who have not had cancer treatment. The study will last up to approximately 4 years.
Not Available
I/II
Not Available
NCT04956640
VICCTHOP2155
A Study of Oral TP-3654 in Patients With Myelofibrosis
This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety,
tolerability, pharmacokinetics and pharmacodynamics of TP-3654 in patients with intermediate
or high-risk primary or secondary MF.
tolerability, pharmacokinetics and pharmacodynamics of TP-3654 in patients with intermediate
or high-risk primary or secondary MF.
Not Available
I/II
Kishtagari, Ashwin
NCT04176198
VICC-DTHEM23002P
A Study with Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.
Not Available
II
Not Available
NCT05828069
VICC-NTPED24012
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
Multiple Cancer Types
CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity
of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after
lymphodepletion consisting of cyclophosphamide and fludarabine.
of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after
lymphodepletion consisting of cyclophosphamide and fludarabine.
Lymphoma,
Phase I
I
Oluwole, Olalekan
NCT04637763
VICC-DTCTT23155P
Stopping Anti-HER2 Therapy to Improve Outcomes for Exceptional Responder Patients with Metastatic HER2-Positive Breast Cancer, The STOP-HER2 Trial
This phase II trial studies how well stopping anti-HER2 therapy works in improving outcomes of patients with HER2-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and have experienced long-term benefit from first-line treatment (exceptional responders). Patients with metastatic HER2-positive breast cancer are currently treated with systemic drugs indefinitely. These drugs include chemotherapy and/or biological agents targeting the HER2 protein. The first drug combination administered after diagnosis of metastatic spread (i.e., first-line treatment) usually combines chemotherapy with anti-HER2 agents (trastuzumab with or without pertuzumab). Chemotherapy is administered for a limited number of months, and anti-HER2 agents are continued indefinitely as maintenance therapy. Some of these patients experience a long-term benefit from first-line treatment without cancer growth and can be defined as exceptional responders. Nevertheless, all patients with this type of tumor typically continue maintenance treatment with anti-HER2 therapy indefinitely. Exceptional responders usually receive treatment for many years. Information learned from this trial may help researchers understand whether maintenance anti-HER2 treatment can be safely stopped in patients with exceptional response to first-line therapy.
Not Available
II
Abramson, Vandana
NCT05721248
VICC-ETBRE23085