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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to follow-up period, approximately 1 year post-treatment
Awards & highlights
Study Summary
This trial tests a new drug to treat advanced cancers. It evaluates how safe and tolerable it is.
Who is the study for?
Adults with advanced solid tumors that have worsened after standard treatments or for whom no standard treatment exists. Participants must be over 18, have a measurable tumor, an expected lifespan of at least 3 months, good performance status and heart function. They should agree to use contraception and not donate gametes during the trial.Check my eligibility
What is being tested?
The safety and effectiveness of DB-1311 are being tested in adults with advanced solid tumors. This Phase 1/2a trial will gradually increase doses to find the safest dose that can still work effectively.See study design
What are the potential side effects?
Specific side effects of DB-1311 aren't listed but may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection, allergic reactions or issues related to where the drug acts on the body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to follow-up period, approximately 1 year post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to follow-up period, approximately 1 year post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of DB-1311
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
+5 moreSecondary outcome measures
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
+1 moreTrial Design
11Treatment groups
Experimental Treatment
Group I: DB-1311 Dose Level 5Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 5 on Day 1 of each cycle Q3W
Group II: DB-1311 Dose Level 4Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 4 on Day 1 of each cycle Q3W
Group III: DB-1311 Dose Level 3Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 3 on Day 1 of each cycle Q3W
Group IV: DB-1311 Dose Level 2Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 2 on Day 1 of each cycle Q3W
Group V: DB-1311 Dose Level 1Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1311 at Dose Level 1 on Day 1 of each cycle Q3W
Group VI: DB-1311 Dose Expansion 6Experimental Treatment1 Intervention
Subjects with other advanced or metastatic solid tumors who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.
Group VII: DB-1311 Dose Expansion 5Experimental Treatment1 Intervention
Subjects with advanced/unresectable, or metastatic melanoma who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.
Group VIII: DB-1311 Dose Expansion 4Experimental Treatment1 Intervention
Subjects with advanced/unresectable, or metastatic castration-resistant prostate cancer (CRPC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.
Group IX: DB-1311 Dose Expansion 3Experimental Treatment1 Intervention
Subjects with advanced/unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.
Group X: DB-1311 Dose Expansion 2Experimental Treatment1 Intervention
Subjects with advanced/unresectable, or metastatic NSCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.
Group XI: DB-1311 Dose Expansion 1Experimental Treatment1 Intervention
Subjects with advanced/unresectable, or metastatic SCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311.
Find a Location
Who is running the clinical trial?
DualityBio Inc.Lead Sponsor
7 Previous Clinical Trials
2,637 Total Patients Enrolled
Raymond ZhaoStudy DirectorDualityBio Inc.
3 Previous Clinical Trials
906 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart failure or serious heart rhythm problems that need treatment.I have been treated with a specific cancer drug linked to a toxin (like trastuzumab deruxtecan).I do not have active hepatitis, or if I have had hepatitis B or C, it is under control.I have an autoimmune or inflammatory condition affecting my lungs.I understand the study's procedures and risks, can consent in writing, and will follow the study requirements.I am fully active or can carry out light work.I do not have active brain metastases needing steroids or seizure meds.I had a heart attack or unstable chest pain in the last 6 months.I have a serious lung condition or need extra oxygen.I cannot or will not stop taking medications that may affect my heart's rhythm.I will not donate or use my eggs for 7 months after the last study drug.I have previously been treated with B7-H3 targeted therapy.I agree to use effective birth control during and after the study for the required time.My heart's pumping ability is normal, confirmed by a heart scan within the last 28 days.I don't have serious side effects from past cancer treatments, except for possible mild ones or hair loss.I have or might have lung scarring or inflammation according to my medical records or recent scans.I haven't had any new cancers, except for certain skin cancers or early-stage cancers treated with curative intent, in the last 3 years.My cancer is advanced, cannot be surgically removed, and has not responded to or cannot be treated with standard therapies.I am 18 years old or older.I have at least one tumor that can be measured or I have prostate cancer with only bone involvement.I agree to provide previous tumor samples or undergo a biopsy for testing.I am currently receiving IV treatment for an uncontrolled infection.I am not pregnant or breastfeeding.I agree not to donate or freeze sperm during and for 4 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: DB-1311 Dose Expansion 5
- Group 2: DB-1311 Dose Expansion 6
- Group 3: DB-1311 Dose Level 4
- Group 4: DB-1311 Dose Expansion 1
- Group 5: DB-1311 Dose Expansion 3
- Group 6: DB-1311 Dose Expansion 4
- Group 7: DB-1311 Dose Expansion 2
- Group 8: DB-1311 Dose Level 1
- Group 9: DB-1311 Dose Level 3
- Group 10: DB-1311 Dose Level 2
- Group 11: DB-1311 Dose Level 5
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 3 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the chief aims underlying this research project?
"The principal aim of this clinical experiment, which will be assayed over a three-week period from Cycle 1 Day 1, is to evaluate the percentage of participants exhibiting adverse events as measured according to CTCAE v5.0. Secondary objectives include determining DB-1311's maximum observed plasma concentration (Cmax), time to reach peak concentration (Tmax) and terminal elimination half-life (T1/2)."
Answered by AI
Are there still positions available for participants in this study?
"According to the clinicaltrials.gov website, this medical trial is not presently enrolling patients. It was initially submitted on July 1st of 2023 and revised 13 days ago. However, there are 2,638 active studies currently seeking participants at this time."
Answered by AI
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