Clinical Trials Search at Vanderbilt-Ingram Cancer Center
A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Multiple Cancer Types
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma
cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of
ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change
in disease activity will be assessed.
ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will
be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2,
participants are placed in 1 of 3 groups called treatment arms. Each group receives a
different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult
participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites
worldwide.
In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily
(QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral
ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day
cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets
QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral
dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will
receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous
injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and
oral dexamethasone tablets once weekly, in 28-day cycles.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, and side effects.
cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of
ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change
in disease activity will be assessed.
ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will
be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2,
participants are placed in 1 of 3 groups called treatment arms. Each group receives a
different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult
participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites
worldwide.
In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily
(QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral
ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day
cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets
QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral
dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will
receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous
injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and
oral dexamethasone tablets once weekly, in 28-day cycles.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, and side effects.
Multiple Myeloma,
Phase I
I
Baljevic, Muhamed
NCT05308654
VICCHEMP2230
Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
Hematologic
Hematologic
Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose
optimization part, and a dose expansion part consisting of two groups evaluating DFV890 in
patients with myeloid diseases. The purpose of this study is to assess the safety,
tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single
agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk)
myelodysplastic syndromes (LR MDS) and lower risk chronic myelomonocytic leukemia (LR CMML).
optimization part, and a dose expansion part consisting of two groups evaluating DFV890 in
patients with myeloid diseases. The purpose of this study is to assess the safety,
tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single
agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk)
myelodysplastic syndromes (LR MDS) and lower risk chronic myelomonocytic leukemia (LR CMML).
Hematologic
I
Kishtagari, Ashwin
NCT05552469
VICC-DTHEM23007P
A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms
Leukemia
Leukemia
This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity
(DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion
(RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.
(DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion
(RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.
Leukemia
I
Savona, Michael
NCT06034002
VICC-DTHEM23416P
Phase 1 Study of Oral TP-1454
Multiple Cancer Types
This study will evaluate the safety and tolerability of oral TP-1454 in patients with
advanced metastatic or progressive solid tumors and anal cancer.
advanced metastatic or progressive solid tumors and anal cancer.
Kidney (Renal Cell),
Phase I
I
Eng, Cathy
NCT04328740
VICCGIP2286
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Phase I
Phase I
This is a Phase 1/2, open-label, non-randomized, 4-part Phase 1 trial to determine the safety
profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint
inhibitor (CPI) pembrolizumab (Keytruda).
profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint
inhibitor (CPI) pembrolizumab (Keytruda).
Phase I
I
Davis, Elizabeth
NCT04198766
VICCPHI2135
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.
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
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.
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.
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
A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101
alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
Not Available
I
Berlin, Jordan
NCT05753722
VICC-DTPHI23182
Nilotinib, Trametinib, and Dabrafenib for the Treatment of BRAF V600 Mutant Metastatic or Unresectable Melanoma
Multiple Cancer Types
This phase I trial is to find out the best dose, possible benefits and/or side effects of nilotinib given together with trametinib and dabrafenib in treating patients with BRAF V600 mutant melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Nilotinib, trametinib, and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nilotinib together with trametinib and dabrafenib may lower the chance of cancer growing or spreading.
Melanoma,
Phase I
I
Johnson, Douglas
NCT04903119
VICCMELP2274
