Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call
1-800-KARMANOS (1-800-527-6266)
or request an appointment below
Back to Results
An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors
Cancer Categories
Gastrointestinal (GI),Lung
Karmanos Trial ID
2022-098
NCT ID
NCT04794699
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Dipesh
Uprety, M.D.
Oncology - Medical
View Profile
Objective:
Primary Objectives:
To assess safety and tolerability at increasing
dose levels of IDE397 in successive cohorts of
participants with selected advanced or
metastatic solid tumors to estimate the
Maximum Tolerated Dose (MTD) and/or
Recommended Phase 2 Dose (RP2D)/schedule
(Part 1: IDE397 Monotherapy Dose
Escalation).
To further assess the safety and tolerability of
IDE397 (MTD and/or RP2D) monotherapy
(Part 2: IDE397 Monotherapy Dose
Expansion).
To assess safety and tolerability at increasing
dose levels of IDE397 in combination with
either docetaxel, paclitaxel, gemcitabine and
nab-paclitaxel or pemetrexed (Part 3: IDE397 Combination Therapy with docetaxel or
paclitaxel Dose Escalation, Part 5:
IDE397 Combination Therapy with
Gemcitabine + nab-paclitaxel Dose Escalation,
Part 7: IDE397 Combination Therapy with
pemetrexed Dose Escalation).
To further assess safety and tolerability of
IDE397 (MTD and/or RP2D) in combination
with either docetaxel, paclitaxel, gemcitabine
and nab-paclitaxel or pemetrexed (Part 4:
IDE397 Combination Therapy with docetaxel
or paclitaxel Dose Expansion, Part 6: IDE397
Combination Therapy with gemcitabine and
nab-paclitaxel Dose Expansion, Part 8: IDE397
Combination Therapy with pemetrexed Dose
Expansion ).
To evaluate preliminary anti-tumor activity
(Parts 2, 4, 6, 8).
Seconday Objectives:
To characterize the single and multiple dose
Pharmacokinetics (PK) of IDE397 and
metabolite following oral administration as a
single agent, and in combination with either
docetaxel, paclitaxel, gemcitabine, and nabpaclitaxel or pemetrexed (all Parts).
To evaluate drug interaction between IDE397
and paclitaxel or docetaxel (Parts 3 and 4).
To evaluate drug interaction between IDE397
and nab-paclitaxel and Gemcitabine (Parts 5
and 6).
To evaluate drug interaction between IDE397
and pemetrexed (Parts 7 and 8).
To evaluate the PD effect of IDE397 as single
agent, and in combination with either
docetaxel, paclitaxel, gemcitabine and nabpaclitaxel, or pemetrexed (all Parts).
To evaluate preliminary anti-tumor activity
(Parts 1, 3, 5, 7).
To assess efficacy of IDE397 administered as
a single agent, and in combination with
docetaxel, paclitaxel, gemcitabine, nabpaclitaxel and pemetrexed by Blinded Imaging
Committee Review (BICR) (Parts 1, 2, 3, 4, 5,
6, 7, 8).
Request an Appointment
Refer a Patient
NCI Dictionary of Cancer Terms
KCI Clinical Trials App
Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Participant must be at least 18 years of age
Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
Have evidence of homozygous loss of MTAP or MTAP deletion
Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns
Measurable disease
ECOG performance status <= 1
Adequate organ function
Able to swallow and retain orally administered study treatment
Recovery from acute effects of prior therapy
Able to comply with contraceptive/barrier requirements
Exclusion Criteria:
Known symptomatic brain metastases
Known primary CNS malignancy
Current active liver or biliary disease
Impairment of gastrointestinal (GI) function
Active uncontrolled infection
Clinically significant cardiac abnormalities
Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor
Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
Radiation therapy within 2 weeks prior to study entry
Prior irradiation to >25% of the bone marrow
Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
Currently receiving another investigational study drug.
Known or suspected hypersensitivity to IDE397/excipients or components
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
Get Directions
Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions
Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Esophagus; Lung; Pancreas
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Chemotherapy
Drugs
IDE397
Loading...