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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 up to follow-up period, approximately 1 year post-treatment
Awards & highlights
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 belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 28 days1 visit
Treatment ~ Varies
Follow Up ~ up to follow-up period, approximately 1 year post-treatment
Screening ~ 28 days
Treatment ~ Varies
Follow Up ~up to follow-up period, approximately 1 year post-treatment
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
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
+5 moreSecondary study objectives
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
+1 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Trial Design
16Treatment groups
Experimental Treatment
Group I: DB-1305 Dose Level 5Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 5 on Day 1 of each cycle Q3W
Group II: DB-1305 Dose Level 4Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 4 on Day 1 of each cycle Q3W
Group III: DB-1305 Dose Level 3Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 3 on Day 1 of each cycle Q3W
Group IV: DB-1305 Dose Level 2Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 2 on Day 1 of each cycle Q3W
Group V: DB-1305 Dose Level 1Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 1 on Day 1 of each cycle Q3W
Group VI: DB-1305 Dose Expansion 9Experimental Treatment1 Intervention
Enrolled subjects with CC who have progressed on or after standard systemic treatments who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group VII: DB-1305 Dose Expansion 8Experimental Treatment1 Intervention
Enrolled subjects with malignant mesothelioma who have progressed on or after standard systemic treatments who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group VIII: DB-1305 Dose Expansion 7Experimental Treatment1 Intervention
Enrolled subjects with EC with disease progression on or after treatment with at least one platinum-containing regimen for advanced or metastatic disease with or without immune checkpoint inhibitor (ICI) who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group IX: DB-1305 Dose Expansion 6Experimental Treatment1 Intervention
Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group X: DB-1305 Dose Expansion 5Experimental Treatment1 Intervention
Enrolled subjects with TNBC who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group XI: DB-1305 Dose Expansion 4Experimental Treatment1 Intervention
Enrolled subjects with BC who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group XII: DB-1305 Dose Expansion 3Experimental Treatment1 Intervention
Enrolled subjects with OC who will receive a single-dose of DB-1305 on a selected dose level once every 3 weeks
Group XIII: DB-1305 Dose Expansion 2Experimental Treatment1 Intervention
Enrolled subjects with NSCLC without AGAs who will receive a single-dose of DB-1305 on a selected dose level once every 3 weeks
Group XIV: DB-1305 Dose Expansion 11Experimental Treatment2 Interventions
Enrolled subjects with NSCLC without AGAs who has not received PD-1/PD-L1, PD-L2, CTLA-4 directed immunotherapy and previously received ≤1 line of platinum-based chemotherapy for advanced or metastatic NSCLC who will receive a single-dose of DB-1305 on a selected dose level in combination with pembrolizumab 200mg once every 3 weeks
Group XV: DB-1305 Dose Expansion 10Experimental Treatment1 Intervention
Enrolled subjects with other advanced or metastatic solid tumors who have progressed on or after standard systemic treatments who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group XVI: DB-1305 Dose Expansion 1Experimental Treatment1 Intervention
Enrolled subjects with NSCLC with AGAs who will receive a single-dose of DB-1305 on a selected dose level once every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2850
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
70 Previous Clinical Trials
110,042 Total Patients Enrolled
DualityBio Inc.Lead Sponsor
8 Previous Clinical Trials
3,645 Total Patients Enrolled
Raymond Zhao, MDStudy DirectorDualityBio Inc.
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: DB-1305 Dose Expansion 3
- Group 2: DB-1305 Dose Level 5
- Group 3: DB-1305 Dose Expansion 8
- Group 4: DB-1305 Dose Expansion 2
- Group 5: DB-1305 Dose Level 1
- Group 6: DB-1305 Dose Expansion 4
- Group 7: DB-1305 Dose Expansion 11
- Group 8: DB-1305 Dose Level 2
- Group 9: DB-1305 Dose Level 4
- Group 10: DB-1305 Dose Level 3
- Group 11: DB-1305 Dose Expansion 1
- Group 12: DB-1305 Dose Expansion 5
- Group 13: DB-1305 Dose Expansion 6
- Group 14: DB-1305 Dose Expansion 7
- Group 15: DB-1305 Dose Expansion 9
- Group 16: DB-1305 Dose Expansion 10
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 28 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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