← Back to Search

MAPK Pathway Inhibitor

D3S-002 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by D3 Bio (Wuxi) Co., Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose up to 24 months

Awards & highlights

Study Summary

This trial aims to test a new drug called D3S-002 in adult patients with advanced solid tumors. The study will look at how safe and tolerable the drug is, how the body processes

Who is the study for?

Adults with advanced solid tumors showing MAPK pathway mutations, who have not responded to standard treatments or for whom no standard care exists. Participants must be in relatively good health (ECOG status 0-1) and have proper organ/marrow function. Those with ongoing serious illnesses, unresolved side effects from past cancer treatments, or conditions affecting drug absorption are excluded.Check my eligibility

What is being tested?

The trial is testing D3S-002, an oral medication taken daily over 21-day cycles. It's aimed at adults with specific genetic changes in their tumors that affect the MAPK pathway—a key signaling route that can lead to cancer growth when altered.See study design

What are the potential side effects?

As this is a first-in-human study of D3S-002, detailed side effects are unknown but may include typical reactions related to cancer medications such as fatigue, digestive issues, skin reactions and potential impacts on blood counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Adverse Events (AEs)

Number of Participants With Dose-Limiting Toxicities (DLTs)

Secondary outcome measures

D3S-002 area under the concentration-time curve (AUC)

D3S-002 half-life (t1/2)

D3S-002 maximum observed plasma concentration (Cmax)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: D3S-002Experimental Treatment1 Intervention

Dose Escalation, D3S-002 administered orally.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

D3 Bio (Wuxi) Co., LtdLead Sponsor

2 Previous Clinical Trials

462 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of subjects actively involved in this research investigation?

"Affirmative. The information found on clinicaltrials.gov reveals that this investigation is presently enlisting subjects. The study was initially uploaded on July 10, 2023, and most recently revised on March 14, 2024. A total of 60 individuals will be enrolled at nine distinct sites."

Answered by AI

In how many locations is this trial currently being conducted?

"The current trial is operational in 9 locations, including Harbin, Shanghai, and Hangzhou. Opting for the nearest site can reduce travel requirements for participants."

Answered by AI

Has the medication D3S-002 received approval from the FDA?

"The safety rating for D3S-002 is a 1 according to our assessment at Power. This Phase 1 trial indicates that there is minimal available data supporting both the safety and efficacy of this intervention."

Answered by AI

Is the process of enrolling participants still ongoing for this medical study?

"Indeed, the details on clinicaltrials.gov highlight that this particular clinical study is presently in search of potential candidates. The trial was originally shared on July 10th, 2023 and last revised on March 14th, 2024. To complete the study successfully, they aim to recruit a total of 60 individuals from nine different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of D3S-002 as Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05886920.