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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 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
~3150

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.

Find a Location

Who is running the clinical trial?

BioNTech SEIndustry Sponsor
77 Previous Clinical Trials
114,920 Total Patients Enrolled
DualityBio Inc.Lead Sponsor
9 Previous Clinical Trials
4,020 Total Patients Enrolled
Lily HuStudy DirectorDualityBio Inc.
5 Previous Clinical Trials
2,412 Total Patients Enrolled
Raymond Zhao, MDStudy DirectorDualityBio Inc.
1 Previous Clinical Trials
1,000 Total Patients Enrolled

Media Library

DB-1305 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05438329 — Phase 1 & 2
Solid Tumors Research Study Groups: DB-1305/BNT325 Dose Level 1, DB-1305/BNT325 Dose Level 2, DB-1305/BNT325 Dose Level 3, DB-1305/BNT325 Dose Level 4, DB-1305/BNT325 Dose Level 5, DB-1305/BNT325 Dose Level 6, DB-1305/BNT325 Dose Level 7, DB-1305/BNT325 in combination with pembrolizumab, DB-1305/BNT325 Dose Expansion 2, Experimental: DB-1305/BNT325 Dose Expansion PM1, Experimental: DB-1305/BNT325 Dose Expansion PM2, Experimental: DB-1305/BNT325 Dose Expansion PM3, Experimental: DB-1305/BNT325 Dose Expansion PM4, DB-1305/BNT325 Dose Expansion 1, DB-1305/BNT325 Dose Expansion 3, DB-1305/BNT325 Dose Expansion 4, DB-1305/BNT325 Dose Expansion 5, DB-1305/BNT325 Dose Expansion 6, DB-1305/BNT325 Dose Expansion 7, DB-1305/BNT325 Dose Expansion 8, DB-1305/BNT325 Dose Expansion 9, Experimental: DB-1305/BNT325 Dose Expansion 10, DB-1305/BNT325 Dose Expansion 11, DB-1305/BNT325 Dose Expansion PB1, Experimental: DB-1305/BNT325 Dose Level 8, Experimental: DB-1305/BNT325 in combination with BNT327, Experimental: DB-1305/BNT325 Dose Expansion PM5, DB-1305/BNT325 Dose Expansion 12
Solid Tumors Clinical Trial 2023: DB-1305 Highlights & Side Effects. Trial Name: NCT05438329 — Phase 1 & 2
DB-1305 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438329 — Phase 1 & 2
~155 spots leftby Jun 2025