What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy and targeted therapies, often result in a range of side effects. Chemotherapy agents like gemcitabine and paclitaxel can cause neutropenia, fatigue, neuropathy, and gastrointestinal issues such as nausea and diarrhea. Targeted therapies, including PI3K inhibitors like buparlisib, frequently lead to hyperglycemia, decreased appetite, and fatigue. Additionally, immune checkpoint inhibitors used in some solid tumors can cause immune-related adverse events such as pneumonitis, rash, and pruritus. These side effects are generally manageable but require careful monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of advanced or metastatic solid tumors. Notable examples include pembrolizumab (Keytruda), an immune checkpoint inhibitor that targets PD-1 and is used for various solid tumors, including melanoma and non-small cell lung cancer. Another example is cabozantinib (Cabometyx), a tyrosine kinase inhibitor approved for medullary thyroid cancer and renal cell carcinoma. Additionally, bevacizumab (Avastin), an angiogenesis inhibitor, has been approved for multiple solid tumors, including colorectal and lung cancers. These treatments, like DB-1305, aim to target and inhibit specific pathways involved in tumor growth and progression.

What other types of research exist?

Promising novel alternatives to DB-1305 for treating advanced solid tumors include: <ol> <li>Dabrafenib and Trametinib: These agents have shown efficacy in patients with BRAF V600E mutations across various tumor types, including biliary tract cancer and other solid tumors.</li> <li></li> </ol> Regorafenib: Demonstrated efficacy and safety in adult patients with metastatic osteosarcoma in phase 2 studies. 3. Cabozantinib: Shown to be effective in patients with advanced Ewing sarcoma or osteosarcoma in phase 2 trials. 4. Sorafenib: Evaluated in relapsed and unresectable high-grade osteosarcoma after failure of standard multimodal therapy. 5. PI3K/mTOR inhibitors: Emerging as potential treatments for osteosarcoma, with ongoing research into their efficacy.

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Unknown

DB-1305 for Solid Tumors

Verified Trial

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

Do you have one of the following types of cancer?: Mesothelioma, Non-Small Cell Lung Cancer, Cervical Cancer, Endometrial Cancer, or Breast Cancer?

Is your cancer HER2 positive?

Must not have

Have you had a medical history of symptomatic congestive heart failure (CHF), interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases?

Do you currently have an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals, or do you currently have or have had human immunodeficiency virus (HIV) infection with acquired immune deficiency syndrome (AIDS) defining illness?

Timeline

Screening 28 days

Treatment Varies

Follow Up from first study treatment administration until the initiation of phase 2a, approximately up to 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called DB-1305 to see if it is safe for patients with advanced solid tumors that are hard to treat. The study will begin with smaller amounts of the drug and increase them over time to find the safest and most effective dose.

Who is the study for?

Adults with advanced solid tumors that have worsened after standard treatments or when no standard treatment exists. Participants must be willing to provide tumor samples, have a life expectancy of at least 3 months, be in good physical condition (ECOG 0-1), and have proper organ function.

What is being tested?

DB-1305 is being tested for safety and effectiveness in treating advanced solid tumors. This early-phase trial gradually increases the dose to find the right balance between benefits and side effects before expanding to more patients.

What are the potential side effects?

As this is a first-in-human study, specific side effects of DB-1305 are not yet known but may include typical reactions seen with cancer drugs such as nausea, fatigue, allergic reactions, or issues related to organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 28 days1 visit

Treatment ~ Varies

Follow Up ~ from first study treatment administration until the initiation of phase 2a, approximately up to 12 months.

Screening ~ 28 days

Treatment ~ Varies

Follow Up ~from first study treatment administration until the initiation of phase 2a, approximately up to 12 months.

This trial's timeline: 28 days for screening, Varies for treatment, and from first study treatment administration until the initiation of phase 2a, approximately up to 12 months. 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-1305/BNT325

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

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

+5 more

Secondary study objectives

Phase 1 & Phase 2a: Pharmacokinetic parameters: (the area under the concentration-time curve from the time zero to the last quantifiable concentration [AUC0-last] of DB-1305/BNT325

Phase 1 & Phase 2a: Pharmacokinetic parameters: the area under the concentration-time curve from time 0 to tau [AUC0-tau] of DB-1305/BNT325

Phase 1 & Phase 2a: Pharmacokinetic parameters: time to Cmax [Tmax] of DB-1305/BNT325

+9 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

28Treatment groups

Experimental Treatment

Group I: Experimental: DB-1305/BNT325 in combination with BNT327Experimental Treatment2 Interventions

Enrolled subjects will receive DB-1305/BNT325 in combination with BNT327

Group II: Experimental: DB-1305/BNT325 Dose Level 8Experimental Treatment1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 8

Group III: Experimental: DB-1305/BNT325 Dose Expansion PM5Experimental Treatment2 Interventions

Enrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group IV: Experimental: DB-1305/BNT325 Dose Expansion PM4Experimental Treatment2 Interventions

Enrolled subjects with OC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group V: Experimental: DB-1305/BNT325 Dose Expansion PM3Experimental Treatment2 Interventions

Enrolled subjects with CC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group VI: Experimental: DB-1305/BNT325 Dose Expansion PM2Experimental Treatment2 Interventions

Enrolled subjects with NSCLC with AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group VII: Experimental: DB-1305/BNT325 Dose Expansion PM1Experimental Treatment2 Interventions

Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group VIII: Experimental: DB-1305/BNT325 Dose Expansion 10Experimental Treatment1 Intervention

Enrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group IX: DB-1305/BNT325 in combination with pembrolizumabExperimental Treatment2 Interventions

Enrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab

Group X: DB-1305/BNT325 Dose Level 7Experimental Treatment1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 7

Group XI: DB-1305/BNT325 Dose Level 6Experimental Treatment1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 6

Group XII: DB-1305/BNT325 Dose Level 5Experimental Treatment1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 5

Group XIII: DB-1305/BNT325 Dose Level 4Experimental Treatment1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 4

Group XIV: DB-1305/BNT325 Dose Level 3Experimental Treatment1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 3

Group XV: DB-1305/BNT325 Dose Level 2Experimental Treatment1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 2

Group XVI: DB-1305/BNT325 Dose Level 1Experimental Treatment1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 1

Group XVII: DB-1305/BNT325 Dose Expansion PB1Experimental Treatment2 Interventions

Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with pembrolizumab

Group XVIII: DB-1305/BNT325 Dose Expansion 9Experimental Treatment1 Intervention

Enrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XIX: DB-1305/BNT325 Dose Expansion 8Experimental Treatment1 Intervention

Enrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XX: DB-1305/BNT325 Dose Expansion 7Experimental Treatment1 Intervention

Enrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXI: DB-1305/BNT325 Dose Expansion 6Experimental Treatment1 Intervention

Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXII: DB-1305/BNT325 Dose Expansion 5Experimental Treatment1 Intervention

Enrolled subjects with Triple-Negative Breast Cancer (TNBC) who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXIII: DB-1305/BNT325 Dose Expansion 4Experimental Treatment1 Intervention

Enrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXIV: DB-1305/BNT325 Dose Expansion 3Experimental Treatment1 Intervention

Enrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2

Group XXV: DB-1305/BNT325 Dose Expansion 2Experimental Treatment1 Intervention

Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on either dose level 1 or dose level 2

Group XXVI: DB-1305/BNT325 Dose Expansion 12Experimental Treatment1 Intervention

Enrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXVII: DB-1305/BNT325 Dose Expansion 11Experimental Treatment1 Intervention

Enrolled subjects with Castration-Resistant Prostate Cancer (CRPC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXVIII: DB-1305/BNT325 Dose Expansion 1Experimental Treatment1 Intervention

subjects with Non-Small Cell Lung Cancer (NSCLC) with actionable genetic alterations (AGAs) who will receive DB-1305/BNT325 on either dose level 1 or dose level 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 6Eligibility criteria met

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, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways crucial for tumor growth and survival, offering a more precise approach with potentially fewer side effects. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. These mechanisms are crucial for solid tumor patients as they provide multiple avenues to control tumor growth, manage symptoms, and potentially improve survival. Treatments like DB-1305, which target advanced solid tumors, are particularly important as they offer hope for patients with limited options due to the advanced stage of their disease.