A Phase 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations
Summary
This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.
Arms & interventions
- DrugD3S-002
Oral Tablet
- DrugD3S-001
Oral Capsule
Outcome measures
Primary
Number of Participants With Adverse Events (AEs)
Time frame: First dose until 30 days after the last dose (or specified in the protocol)
Maximum tolerated dose (MTD) based on Dose limiting toxicities (DLTs)
Time frame: First dose up to 24 months
Recommended Phase 2 dose (RP2D)
Time frame: First dose up to 24 months
Secondary
Part 1: D3S-002 maximum observed plasma concentration (Cmax)
Time frame: First dose up to 24 months
Part 2: D3S-002 and D3S-001 maximum observed plasma concentration (Cmax)
Time frame: First dose up to 24 months
Part 1: D3S-002 time to maximum plasma concentration (tmax)
Time frame: First dose up to 24 months
Part 2: D3S-002 and D3S-001 time to maximum plasma concentration (tmax)
Time frame: First dose up to 24 months
Part 1: D3S-002 half-life (t1/2)
Time frame: First dose up to 24 months
Part 2: D3S-002 and D3S-001 half-life (t1/2)
Time frame: First dose up to 24 months
Part 1: D3S-002 area under the concentration-time curve (AUC)
Time frame: First dose up to 24 months
Part 2: D3S-002 and D3S-001 area under the concentration-time curve (AUC)
Time frame: First dose up to 24 months
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Until disease progression or end of treatment (up to approximately 24 months)
Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Until disease progression or end of treatment (up to approximately 24 months)
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Until disease progression or end of treatment (up to approximately 24 months)
Eligibility criteria
Study locations (3)
D3 Bio Investigative Site
Detroit, Michigan, 48202
D3 Bio Investigative Site
New York, New York, 10029
D3 Bio Investigative Site
Nashville, Tennessee, 37203