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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 |
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/ |
A Dose-Escalation and Dose-Expansion Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
Miscellaneous
Miscellaneous
The primary objective of this study is to identify the recommended dose for expansion (RDE)
(and recommended schedule) and/or the maximum tolerated dose (MTD), and characterize the
safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.
(and recommended schedule) and/or the maximum tolerated dose (MTD), and characterize the
safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.
Miscellaneous
I
Davis, Elizabeth
NCT05389462
VICCPHI2225
A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Multiple Cancer Types
This is a first in human, multicenter, open label, Phase 1a/b dose escalation and dose
expansion study to establish the maximum tolerated dose (MTD), recommended Phase 2 dose
(RP2D), and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose
escalating fashion in subjects with advanced solid tumors. Up to 36 subjects will be enrolled
into the Phase 1a dose escalation part of the study. Every effort will be made to ensure
approximately 50% of all subjects enrolled in this study will be subjects with the tumors of
special interest such as squamous cell carcinoma of the head and neck (SCCHN), colorectal
cancer (CRC), non-small cell lung cancer (NSCLC), and transitional cell carcinoma of the
bladder (TCC). Subjects with other solid tumor types are also eligible provided study
selection criteria are met and they do not exceed 50% of all enrolled subjects. The study
will be conducted in the United States at approximately 3 to 5 sites. This Phase 1a/b study
will follow a traditional 3+3 design. The starting dose level will be 10 mg QD, escalating to
20, 40, 75, 125, and 150 mg QD as safety allows. All doses are to be administered in the
fasting state with water at least 1 hour before food or at least 2 hours after food. The
Phase 1b dose expansion part will involve cohort expansion at up to 2 dose levels selected
from the dose escalation data by the safety monitoring committee (SMC), to obtain additional
safety and preliminary efficacy information. Each cohort in Phase 1b will enroll 15 subjects.
The study will be expanded into a Phase 2 study via protocol amendment which will then assess
the dose and tumor type(s) selected in Phase 1a/b as the most appropriate for further
clinical development. Subjects will be dosed until unacceptable toxicity, disease progression
per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST), discontinuation of
treatment for other protocol allowed reason (eg, subject refusal), any other administrative
reasons, or after 2 years of treatment, whichever occurs first. For scheduling purposes,
dosing will occur in 3 week cycles and computed tomography (CT) scans will be conducted once
every 6 weeks with the first postbaseline scan after 6 weeks of dosing (precycle 3).
expansion study to establish the maximum tolerated dose (MTD), recommended Phase 2 dose
(RP2D), and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose
escalating fashion in subjects with advanced solid tumors. Up to 36 subjects will be enrolled
into the Phase 1a dose escalation part of the study. Every effort will be made to ensure
approximately 50% of all subjects enrolled in this study will be subjects with the tumors of
special interest such as squamous cell carcinoma of the head and neck (SCCHN), colorectal
cancer (CRC), non-small cell lung cancer (NSCLC), and transitional cell carcinoma of the
bladder (TCC). Subjects with other solid tumor types are also eligible provided study
selection criteria are met and they do not exceed 50% of all enrolled subjects. The study
will be conducted in the United States at approximately 3 to 5 sites. This Phase 1a/b study
will follow a traditional 3+3 design. The starting dose level will be 10 mg QD, escalating to
20, 40, 75, 125, and 150 mg QD as safety allows. All doses are to be administered in the
fasting state with water at least 1 hour before food or at least 2 hours after food. The
Phase 1b dose expansion part will involve cohort expansion at up to 2 dose levels selected
from the dose escalation data by the safety monitoring committee (SMC), to obtain additional
safety and preliminary efficacy information. Each cohort in Phase 1b will enroll 15 subjects.
The study will be expanded into a Phase 2 study via protocol amendment which will then assess
the dose and tumor type(s) selected in Phase 1a/b as the most appropriate for further
clinical development. Subjects will be dosed until unacceptable toxicity, disease progression
per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST), discontinuation of
treatment for other protocol allowed reason (eg, subject refusal), any other administrative
reasons, or after 2 years of treatment, whichever occurs first. For scheduling purposes,
dosing will occur in 3 week cycles and computed tomography (CT) scans will be conducted once
every 6 weeks with the first postbaseline scan after 6 weeks of dosing (precycle 3).
Miscellaneous,
Phase I
I
Berlin, Jordan
NCT05121948
VICCPHI2229
9-ING-41 in Patients With Advanced Cancers
Multiple Cancer Types
GSK-3 is a potentially important therapeutic target in human malignancies. The Actuate 1801
Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3
inhibitor, as a single agent and in combination with cytotoxic agents, in patients with
refractory cancers.
Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3
inhibitor, as a single agent and in combination with cytotoxic agents, in patients with
refractory cancers.
Miscellaneous,
Phase I
I/II
Davis, Elizabeth
NCT03678883
VICCPHI19127
A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors
Multiple Cancer Types
This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized
anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with
nivolumab or standard of care. It is being tested against advanced and/or metastatic solid
tumors including gastric, gastroesophageal junction, pancreatic cancers.
anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with
nivolumab or standard of care. It is being tested against advanced and/or metastatic solid
tumors including gastric, gastroesophageal junction, pancreatic cancers.
Miscellaneous,
Phase I
I
Berlin, Jordan
NCT04396821
VICCPHI2047
Study of DF1001 in Patients With Advanced Solid Tumors
Multiple Cancer Types
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell
activation signals to specific receptors on cancer cells. The study will occur in two phases.
The first phase will be a dose escalation phase, enrolling patients with various types of
solid tumors that express human epidermal growth factor receptor 2 (HER2). Two combination
therapy cohorts will be opened for enrollment, DF1001 + nivolumab and DF1001 + Nab
paclitaxel. The second phase will include a dose expansion using the best dose selected from
the first phase of the study. Multiple cohorts will be opened with eligible patients having
either selected solid tumors, or solid tumors expressing high levels of HER2.
activation signals to specific receptors on cancer cells. The study will occur in two phases.
The first phase will be a dose escalation phase, enrolling patients with various types of
solid tumors that express human epidermal growth factor receptor 2 (HER2). Two combination
therapy cohorts will be opened for enrollment, DF1001 + nivolumab and DF1001 + Nab
paclitaxel. The second phase will include a dose expansion using the best dose selected from
the first phase of the study. Multiple cohorts will be opened with eligible patients having
either selected solid tumors, or solid tumors expressing high levels of HER2.
Miscellaneous,
Phase I
I/II
Berlin, Jordan
NCT04143711
VICCPHI2064
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, with a Specific Focus on Patients with Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer
Multiple Cancer Types
This phase I trial investigates the side effects and best dose of BAY 1895344 when given together with usual chemotherapy (irinotecan or topotecan) in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), with a specific focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding BAY 1895344 to irinotecan or topotecan may help to slow the growth of tumors for longer than seen with those drugs alone.
Miscellaneous,
Phase I
I
Heumann, Thatcher
NCT04514497
VICCNCIPHI10402
TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
Multiple Cancer Types
TTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to
determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy
(HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor) or cetuximab
(EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies.
The study is enrolling in the dose expansion arms.
determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy
(HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor) or cetuximab
(EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies.
The study is enrolling in the dose expansion arms.
Miscellaneous,
Phase I
I
Keedy, Vicki
NCT04485013
VICCMD2172
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
Miscellaneous
Miscellaneous
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo
given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous
cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with
radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in
increasing recurrence free survival (RFS).
given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous
cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with
radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in
increasing recurrence free survival (RFS).
Miscellaneous
III
Choe, Jennifer
NCT03833167
VICCHN18177
Impact of Human-Animal Interactions on Children with Life-Threatening Conditions and their Parents
Multiple Cancer Types
This clinical trial explores the impact of human-animal interactions on children with life-threatening conditions and their parent. Studies have shown that animals can be entertaining and promote relaxation and comfort during stressful events. Having animal-assisted interaction visits on a routine basis, with a trained animal-handler and his/her dog, may make the cancer treatment process less stressful for the parent and children.
Miscellaneous,
Pediatrics
N/A
Gilmer, Mary Jo
NCT04310345
VICCPED2003
Improving Care after Inherited Cancer Testing (IMPACT) Study
Miscellaneous
Miscellaneous
This clinical trial investigates factors associated with access to genetic risk assessment, counseling, and testings services. The trial also seeks to refine and evaluate the effectiveness of online tools on improving cancer risk management practices and family communication of genetic test results.
Miscellaneous
N/A
Pal, Tuya
NCT04763915
VICCSUPP2112