This is a multicenter, Phase 1/2 clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with advanced/metastatic solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Administered orally
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
SCRI HealthONE
Denver, Colorado, United States
SCRI Florida Cancer Specialists
Orlando, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Oncology
San Antonio, Texas, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
DLTs reported during ModA Part 1.
Time frame: Cycle 1 (28 days)
Objective Response Rate (ORR) (ModA Part 2)
ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.
Time frame: Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
ORR (ModA Part 1)
ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.
Time frame: Start of Therapy to PD, Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Progression-Free Survival (PFS) (ModA Part 1 and 2)
PFS is the time from start of therapy to PD or death due to any cause.
Time frame: Start of Therapy to PD or Death Due to Any Cause (Estimated up to 24 months)
Overall Survival (OS) (ModA Part 1 and 2)
OS is the time from start of therapy to death from any cause.
Time frame: Start of Therapy to Death Due to Any Cause (Estimated up to 36 months)
Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2)
Cmax (ModA Part 1 and 2)
Time frame: Predose up to 12 hours postdose
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