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KaCrole Higgins was diagnosed with breast cancer in 2020. “In May 2020, I found a lump in my breast. I cried. By June, it was diagnosed as breast cancer, triple positive, stage 1A. While getting this cancer diagnosis was devastating, it also became an opportunity. Suddenly, the cancer gave me clarity. It gave me clarity about what was important, what was good in my life, what was toxic in my life, and what I needed to do.” Click below to read more of KaCrole’s story

https://momentum.vicc.org/2022/04/cancer-gave-me-clarity/

If Landon Ryan had been diagnosed with bilateral retinoblastoma 10, 20 or 30 years ago, she might not be here today with nearly perfect vision.Thanks to recent improvements in the treatment for this rare form of cancer that almost exclusively affects children under the age of 5, the diagnosis had the power to change Landon’s life when she was 11 months old, but not to take it — or her eyesight. Click below to learn more about Landon and her story.

https://momentum.vicc.org/2022/04/brighter-outlook/
Displaying 1 - 10 of 26

Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

Multiple Cancer Types

The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy
of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed
acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have
comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of
the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination
therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax)
exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and
venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will
follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
Leukemia, Phase I
I/II
Savona, Michael
NCT04657081
VICCHEMP20102

A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors

Multiple Cancer Types

This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a
lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of
lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects
with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with
related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.
Pancreatic, Phase I
I/II
Cardin, Dana
NCT05726864
VICCPHI2249

Selinexor and Venetoclax in Combination with Chemotherapy for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage

Multiple Cancer Types

This phase I trial evaluates the side effects and best dose of selinexor and venetoclax in combination with chemotherapy in treating patients with acute myeloid leukemia or acute leukemia of ambiguous linage that has come back (relapsed) or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Selinexor may stop the growth of cancer cells by blocking CRM1, which help the body's immune system to find and kill cancer cells. Chemotherapy drugs, such as 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. Colony-stimulating factors, such as granulocyte colony-stimulating factor, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving venetoclax and selinexor with chemotherapy may help control the disease in patients with acute myeloid leukemia or acute leukemia of ambiguous lineage.
Leukemia, Pediatric Leukemia, Pediatrics, Phase I
I
Smith, Brianna
NCT04898894
VICCPEDP2235

A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors

Multiple Cancer Types

The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:

1. what is the maximum tolerated dose and recommended dose for phase 2?

2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
Breast, Cervical, Gastrointestinal, Gynecologic, Head/Neck, Lung, Phase I, Urologic
I
Berlin, Jordan
NCT05683418
VICC-DTPHI23103

Phase 1b Combo w/ Ribociclib and Alpelisib

Multiple Cancer Types

This is a Phase 1b open-label, 2-part study in 2 treatment groups. The 2 treatment groups are
as follows:

Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI, Novartis Pharmaceuticals
Corporation).

Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY, Novartis Pharmaceuticals
Corporation).
Breast, Phase I
I
Nunnery, Sara
NCT05508906
VICCBREP2267

A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML

Multiple Cancer Types

Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of
an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose
levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)
followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label
crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a
randomized open-label crossover study comparing the final oral ASTX030 dose to SC
azacitidine. The duration of the study is expected to be approximately 48 months.
Leukemia, Myelodysplastic Syndrome, Phase I
I/II/III
Savona, Michael
NCT04256317
VICCHEMP19146

A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor

Multiple Cancer Types

The primary objective of this study is to assess the safety and tolerability and to determine
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).
Gynecologic, Liver, Phase I
I
Heumann, Thatcher
NCT04008797
VICC-DTPHI23106

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Multiple Cancer Types

The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination
with talquetamab or teclistamab, and to characterize the safety and tolerability of
talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.
Multiple Myeloma, Phase I
I
Baljevic, Muhamed
NCT05338775
VICCHEMP2253

RBS2418 Evaluation in Subjects With Unresectable or Metastatic Tumors

Phase I

RBS2418 (investigational product) is a specific immune modulator, working through
ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor
immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine
monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine
production in the tumors. RBS2418 has the potential to be an important therapeutic option for
subjects both as monotherapy and in combination with checkpoint blockade. This study is an
open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in
combination with pembrolizumab or as a monotherapy in subjects with advanced unresectable,
recurrent or metastatic tumors.
Phase I
I
Berlin, Jordan
NCT05270213
VICCPHI2289

FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies

Multiple Cancer Types

This Phase 1, multicenter, open-label, dose escalation study is designed to assess the
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical
activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects
with advanced hematologic malignancies.
Leukemia, Myelodysplastic Syndrome, Phase I
I
Kishtagari, Ashwin
NCT04891757
VICCHEMP2138