What side effects are associated with this type of intervention?

Common treatments for HER2-positive solid tumors, such as trastuzumab, trastuzumab-emtansine (T-DM1), and fam-trastuzumab deruxtecan, are associated with several side effects. Trastuzumab can cause chills, fever, nausea, vomiting, weakness, headache, and cardiac dysfunction. T-DM1 may lead to decreased neutrophil count, anemia, nausea, fatigue, and interstitial lung disease. Fam-trastuzumab deruxtecan is linked to decreased neutrophil count, anemia, nausea, and interstitial lung disease, with a risk of severe lung complications. These side effects highlight the importance of monitoring and managing toxicities during treatment.

What prior FDA approvals exist?

Several FDA-approved treatments target the HER2 protein in solid tumors, similar to the investigational drug D3L-001. Trastuzumab (Herceptin) was one of the first monoclonal antibodies approved for HER2-positive breast cancer. Pertuzumab (Perjeta) is another monoclonal antibody that targets HER2 and is often used in combination with trastuzumab. T-DM1 (ado-trastuzumab emtansine, Kadcyla) is an antibody-drug conjugate that combines trastuzumab with a cytotoxic agent. These therapies have significantly improved outcomes for patients with HER2-positive cancers and are used in various treatment settings, including metastatic disease.

What other types of research exist?

Promising alternatives to D3L-001 for HER2-positive solid tumors include: 1) Trastuzumab Deruxtecan (Enhertu), which has shown significant improvements in PFS and OS in previously treated HER2-positive breast cancer patients. 2) Trastuzumab Emtansine (T-DM1), which has demonstrated improved survival outcomes compared to lapatinib plus capecitabine in the EMILIA trial. 3) Margetuximab, which has shown efficacy in patients with pretreated HER2-positive advanced breast cancer. These therapies have been evaluated in recent clinical trials and have shown promising results in terms of efficacy and safety.

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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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called D3L-001 for patients with advanced cancers that have a specific protein called HER2. The study aims to see if the drug is safe and how it affects the body. Researchers hope that D3L-001 will help slow down or stop the growth of these tumors.

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.

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.

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 ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors, particularly those targeting the HER2 protein, include targeted therapies and monoclonal antibodies. These treatments work by specifically binding to the HER2 receptors on cancer cells, inhibiting pathways that promote cell proliferation and survival. This targeted mechanism is significant for patients as it aims to reduce tumor growth while minimizing damage to normal cells, leading to fewer side effects compared to traditional chemotherapy.

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