What side effects are associated with this type of intervention?

Common treatments for advanced solid tumors, including immune checkpoint inhibitors, antiangiogenic agents, and chemotherapy, are associated with a range of side effects. Immune checkpoint inhibitors can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. Antiangiogenic agents like bevacizumab and pazopanib often lead to hypertension, diarrhea, and hypothyroidism. Chemotherapy agents, including doxorubicin and paclitaxel, frequently result in myelosuppression, alopecia, mucosal inflammation, and peripheral neuropathy. These side effects vary in severity and frequency, necessitating careful monitoring and management during treatment.

What prior FDA approvals exist?

Several FDA-approved treatments for advanced solid tumors include immunoconjugates and targeted therapies. For instance, Gemtuzumab ozogamicin, an immunoconjugate consisting of an anti-CD33 monoclonal antibody linked to calicheamicin, is approved for certain types of leukemia and has shown efficacy in solid tumors expressing specific markers. Additionally, pembrolizumab and atezolizumab, both immune checkpoint inhibitors, have been approved for various solid tumors, including non-small cell lung cancer and melanoma, often in combination with other therapies. These treatments highlight the trend towards targeted and immunotherapy approaches in managing advanced solid tumors.

What other types of research exist?

Promising novel alternatives to DB-1311 for solid tumor patients include: 1) Pembrolizumab, which has shown efficacy in various solid tumors including non-small cell lung cancer and melanoma, as evidenced by the KEYNOTE studies. 2) Atezolizumab, which has been effective in non-small cell lung cancer and other solid tumors, as demonstrated in the IMpower trials. 3) Cabozantinib, which has shown activity in medullary thyroid cancer and other solid tumors. These alternatives have demonstrated safety and efficacy in recent clinical trials and could be considered for treatment in 2024.

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DB-1311 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by DualityBio Inc.

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 follow-up period, approximately 1 year post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, DB-1311, in patients with advanced solid tumors. It aims to find the safest and most effective dose and then confirm its safety and effectiveness in more patients.

Who is the study for?

Adults with advanced solid tumors that have worsened after standard treatments or for whom no standard treatment exists. Participants must be over 18, have a measurable tumor, an expected lifespan of at least 3 months, good performance status and heart function. They should agree to use contraception and not donate gametes during the trial.

What is being tested?

The safety and effectiveness of DB-1311 are being tested in adults with advanced solid tumors. This Phase 1/2a trial will gradually increase doses to find the safest dose that can still work effectively.

What are the potential side effects?

Specific side effects of DB-1311 aren't listed but may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection, allergic reactions or issues related to where the drug acts on the body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to follow-up period, approximately 1 year post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to follow-up period, approximately 1 year post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to follow-up period, approximately 1 year post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of DB-1311

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs

Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

+5 more

Secondary study objectives

Phase 1 & 2a: ADA incidence

Phase 1 & 2a: Anti-drug antibody (ADA) prevalence

Phase 1 & Phase 2a: Overall Survival (OS)

+10 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

13Treatment groups

Experimental Treatment

Group I: DB-1311 Dose Level 5Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 5 on Day 1 of each cycle Q3W

Group II: DB-1311 Dose Level 4Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 4 on Day 1 of each cycle Q3W

Group III: DB-1311 Dose Level 3Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 3 on Day 1 of each cycle Q3W

Group IV: DB-1311 Dose Level 2Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 2 on Day 1 of each cycle Q3W

Group V: DB-1311 Dose Level 1Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 1 on Day 1 of each cycle Q3W

Group VI: DB-1311 Dose Expansion 8Experimental Treatment1 Intervention

Subjects with other advanced or metastatic solid tumors who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.

Group VII: DB-1311 Dose Expansion 7Experimental Treatment1 Intervention

Subjects with advanced/unresectable, or metastatic cervical cancer who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.

Group VIII: DB-1311 Dose Expansion 6Experimental Treatment1 Intervention

Subjects with advanced/unresectable, or metastatic HCC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.

Group IX: DB-1311 Dose Expansion 5Experimental Treatment1 Intervention

Subjects with advanced/unresectable, or metastatic melanoma who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.

Group X: DB-1311 Dose Expansion 4Experimental Treatment1 Intervention

Subjects with advanced/unresectable, or metastatic castration-resistant prostate cancer (CRPC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.

Group XI: DB-1311 Dose Expansion 3Experimental Treatment1 Intervention

Subjects with advanced/unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.

Group XII: DB-1311 Dose Expansion 2Experimental Treatment1 Intervention

Subjects with advanced/unresectable, or metastatic NSCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.

Group XIII: DB-1311 Dose Expansion 1Experimental Treatment1 Intervention

Subjects with advanced/unresectable, or metastatic SCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.

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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 include chemotherapy, targeted therapy, immunotherapy, and hormone therapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapy, such as tyrosine kinase inhibitors, specifically targets molecular pathways crucial for cancer cell growth and survival, minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Hormone therapy blocks hormones that fuel certain cancers, like breast and prostate cancer. These mechanisms are crucial for solid tumor patients as they offer multiple strategies to control tumor growth, improve survival rates, and enhance quality of life. The DB-1311 trial, which evaluates a new treatment for advanced solid tumors, aims to find safer and more effective options by focusing on the safety and tolerability of novel therapies.

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