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Monoclonal Antibodies

D3L-001 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 until disease progression or end of treatment (up to approximately 24 months)

Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe, works against cancer, and how it affects the body.

Who is the study for?

This trial is for people with advanced solid tumors that test positive for HER2. Participants should be relatively healthy and active (ECOG status of 0 or 1), have a heart pumping function (LVEF) of at least 50%, and good organ/marrow function. They can't join if they've had certain cancer treatments, major surgery, or immunosuppressive meds within specific time frames before the study starts.Check my eligibility

What is being tested?

The trial is testing D3L-001 as a solo treatment to see how safe it is, how the body handles it (PK/PD), if it causes an immune response, and whether it works against HER2-positive tumors. It's in Phase I which means this is the first time humans are trying it out.See study design

What are the potential side effects?

Since this is a first-in-human study, exact side effects aren't known yet. However, similar drugs often cause immune system reactions, fatigue, nausea, potential heart issues due to its action on HER2-positive cells which could also affect normal cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until disease progression or end of treatment (up to approximately 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until disease progression or end of treatment (up to approximately 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until disease progression or end of treatment (up to approximately 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

Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs)

Number of Participants With Adverse Events (AEs)

Secondary outcome measures

D3L-001 area under the concentration-time curve (AUC)

D3L-001 half-life (t1/2)

D3L-001 maximum observed plasma concentration (Cmax)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: D3L-001Experimental Treatment1 Intervention

Part 1 Dose Escalation in subjects with HER2-positive advanced solid tumors Cohort 1 (starting dose) Cohort 2 Cohort 3 Cohort 4 Cohort 5 Part 2 Dose Expansion Cohort A for subjects with HER2-positive advanced breast cancer Cohort B for subjects with HER2-positive advanced gastric cancer/gastroesophageal junction cancer

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

412 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 risks have been associated with the administration of D3L-001?

"There is limited evidence to support the efficacy and safety of D3L-001, thus it has been scored a 1 on our rating scale."

Answered by AI

Are there still opportunities for volunteers to join the experiment?

"Data available on clinicaltrials.gov reveals that this medical trial is presently enrolling participants, having initially been posted on September 19th 2023 and most recently updated on October 16th 2023."

Answered by AI

To what extent is the participant pool for this research endeavor expanding?

"Indeed, current information hosted on clinicaltrials.gov exhibits that this trial is actively recruiting participants. This study was initially publicized on September 19th 2023 and the most recent update occurred October 16th of the same year. The medical research requires 110 individuals across 1 site to be enrolled in order for the experiment to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors

2023. "A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05957536.