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Trial Title: Study of D3S-002 as Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

NCT ID: NCT05886920

Condition: Advanced Solid Tumors With MAPK Pathway Mutations

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Advanced solid tumors
mitogen-activated protein kinase
mutation

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: D3S-002
Description: Oral
Arm group label: D3S-002

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.

Criteria for eligibility:
Criteria:
Inclusion: - Subjects must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor with evidence of progressive disease. - Subjects must have documented mitogen-activated protein kinase (MAPK) pathway mutation(s) within the last 5 years identified by a local test on tumor tissue or blood (eg, rat sarcoma (RAS), rapidly accelerated fibrosarcoma (RAF), and MAPK kinase (MAPKK) mutations). - Subjects must be refractory to or intolerable with standard treatment, or have no available standard of care. - Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. - Subject must have adequate organ and marrow function within the screening period. Exclusion: - Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol. - Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent. - Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia). - Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy. - Any concurrent chemotherapy, immunotherapy, targeted therapy, cell therapy, biologic or hormonal therapy and any medical devices for cancer treatment.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations: