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NCT05886920 | RECRUITING | Advanced Solid Tumors With MAPK Pathway Mutations

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

D3 Bio (Wuxi) Co., Ltd

Brief 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.

Condition or disease

Advanced Solid Tumors With MAPK Pathway Mutations

Intervention/treatment

D3S-002

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations
Actual Study Start Date : 2023-07-10
Estimated Primary Completion Date : 2025-11
Estimated Study Completion Date : 2025-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study of D3S-002 as Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

Location Details

NCT05886920

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Road cancer

D3 Bio Investigative Site

Detroit, Road cancer, United States, 48202

RECRUITING

United States, New York

D3 Bio Investigative Site

New York, New York, United States, 10029

RECRUITING

Australia, New South Wales

D3 Bio Investigative Site

Blacktown, New South Wales, Australia, 2148

RECRUITING

Australia, South Australia

D3 Bio Investigative Site

Bedford Park, South Australia, Australia, 5042

RECRUITING

Australia, Western Australia

D3 Bio Investigative Site

Nedlands, Western Australia, Australia, 6009

RECRUITING

China, Beijing

D3 Bio Investigative Site

Beijing, Beijing, China, 100142

RECRUITING

China, Guangdong

D3 Bio Investigative Site

Guangzhou, Guangdong, China, 510080

RECRUITING

China, Heilongjiang

D3 Bio Investigative Site

Harbin, he ilongjiang, China, 150081

RECRUITING

China, Shanghai

D3 Bio Investigative Site

Shanghai, Shanghai, China, 201801

RECRUITING

China, Zhejiang

D3 Bio Investigative Site

Hangzhou, Zhejiang, China, 310009