Testing D3S-002 for advanced solid tumors with specific mutations
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
This study is testing a new oral medication called D3S-002 to see if it can help adults with advanced solid tumors that have specific mutations and haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | D3 Bio (Wuxi) Co., Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 10 sites (Detroit, Michigan and 9 other locations) |
| Trial ID | NCT05886920 on ClinicalTrials.gov |
What this trial studies
This first-in-human study evaluates the safety and tolerability of D3S-002, an oral medication administered daily for 21-day cycles, in adults with advanced solid tumors that have mutations in the MAPK pathway. Participants must have confirmed metastatic or locally advanced tumors that are progressing and have not responded to standard treatments. The study will also assess the pharmacokinetics of D3S-002 and determine the recommended phase 2 dose for future studies.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced solid tumors that have documented MAPK pathway mutations and who have not responded to standard treatments.
Not a fit: Patients with uncontrolled illnesses or those who have received certain prior treatments without adequate washout periods may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have specific genetic mutations.
How similar studies have performed: While this approach is novel in its specific targeting of MAPK pathway mutations, similar studies have shown promise in treating advanced solid tumors with targeted therapies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Detroit, Michigan and 9 other locations
- D3 Bio Investigative Site — Detroit, Michigan, United States (Recruiting)
- D3 Bio Investigative Site — New York, New York, United States (Recruiting)
- D3 Bio Investigative Site — Blacktown, New South Wales, Australia (Recruiting)
- D3 Bio Investigative Site — Bedford Park, South Australia, Australia (Recruiting)
- D3 Bio Investigative Site — Nedlands, Western Australia, Australia (Recruiting)
- D3 Bio Investigative Site — Beijing, Beijing, China (Recruiting)
- D3 Bio Investigative Site — Guangzhou, Guangdong, China (Recruiting)
- D3 Bio Investigative Site — Harbin, Heilong Jiang, China (Recruiting)
- D3 Bio Investigative Site — Shanghai, Shanghai, China (Recruiting)
- D3 Bio Investigative Site — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Medical Director
- Email: D3bio_CT@d3bio.com
- Phone: +86 21 61635900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.