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New treatment option for Advanced Solid Tumor
Official title A Study of DB-1310 in Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05785741
What this study is testing
What is DB-1310?
DB-1310 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed...
- Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is...
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1...
- Has a life expectancy of ≥ 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
You likely can't join if
- Prior treatment with HER3 targeted therapy.
- Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled people in Combo...
- Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia...
- Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6...
- Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch...
- Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) based on a 12-lead electrocardiogram...
See the full eligibility criteria
Who can join
- Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
- Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after...
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
- Has a life expectancy of ≥ 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
- Is willing to provide archived tumor tissue or undergo fresh tumor biopsy for the retrospective measurement of human epidermal growth factor receptor 3 (HER3) level and other biomarkers if no contraindication. For HER2...
- Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.
- Male and female people of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months...
- Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal...
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Male people must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration.
- Female people must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
- Phase 1 monotherapy people (Phase 1 monotherapy ONLY):
- Pathologically documented advanced/unresectable, or metastatic solid tumors that is refractory to or intolerable with standard treatment, or for which standard treatment is not available.
What rules you out
- Prior treatment with HER3 targeted therapy.
- Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled people in Combo A of Phase 1 and people in Cohort 2e of Phase 2a, and not applicable...
- Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
- Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as...
- Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR...
- Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.
- Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval. For Combo B of Phase 1 and Cohort 2g, 2k of Phase 2a, patients currently receiving (or unable to stop use prior to...
- Has a history of (non-infectious) ILD/pneumonitis and/or radiation pneumonitis that required glucocorticoids, or has current ILD/pneumonitis and/or radiation pneumonitis, or where suspected ILD/pneumonitis and/or...
- Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to Cycle 1 Day 1, severe asthma, severe...
- Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
- Know human immunodeficiency virus (HIV) infection. people should be tested for HIV prior to enrollment if required by local regulations or by the IRB/ EC.
- people have active viral (any etiology) hepatitis are excluded.
- Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by serum pregnancy tests performed within 7 days prior to Cycle 1 Day 1.
- Has clinically active central nervous system (CNS) metastases, defined as untreated, or symptomatic, or requiring therapy with glucocorticoids or anticonvulsants to control associated symptoms. However, people with...
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, grade ≤ 1 or baseline.
- Has multiple primary malignancies within 5 years before enrollment, except adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer), curatively treated in-situ disease (e.g...
- Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation or evaluation of the clinical study in the opinion of the investigator.
- Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- Patients with other reasons that, in the opinion of the Investigator, make them unsuitable to participate in this study.
- For Combo B of Phase 1 and Cohort 2g, 2k, 2m of Phase 2a, patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel...
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Santa Monica, California, United States
- Coral Gables, Florida, United States
- Margate, Florida, United States
- Orlando, Florida, United States
- Plantation, Florida, United States
- Sarasota, Florida, United States
- Tamarac, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Florham Park, New Jersey, United States
- Cincinnati, Ohio, United States
- Nashville, Tennessee, United States
- Fairfax, Virginia, United States
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Wuxi, Jiangsu, China
- Changchun, Jilin, China
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Santa Monica, California, United States; Coral Gables, Florida, United States; Margate, Florida, United States; Orlando, Florida, United States; Plantation, Florida, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.