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.

← Back to Search

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 up to follow-up period, approximately 1 year post-treatment

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 ~ 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

This trial's timeline: 28 days 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-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 more

Secondary study objectives

Phase 1 & Phase 2a: Pharmacokinetic-AUC

Phase 1 & Phase 2a: Pharmacokinetic-Cmax

Phase 1 & Phase 2a: Pharmacokinetic-T1/2

+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

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

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

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

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

~3150

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.