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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 see if it's safe and works for advanced cancer patients.
Who is the study for?
Adults (≥18 years) with advanced solid tumors who've tried standard treatments without success or can't tolerate them. They must have a life expectancy of ≥3 months, good organ function, and an ECOG performance status of 0-1. Participants need measurable lesions per RECIST criteria or qualify for Phase 2a Cohort 2c. Women shouldn't be pregnant/breastfeeding and along with men, must use contraception.Check my eligibility
What is being tested?
DB-1310 is being tested in this Phase 1/2a trial to see how safe it is and how well people with advanced solid tumors can handle different doses. The study will gradually increase the dose (dose-escalation) and then give it to more people at the best dose found (dose-expansion).See study design
What are the potential side effects?
Specific side effects are not listed but generally, participants may experience issues related to drug tolerance including reactions at the infusion site, fatigue, digestive problems, changes in blood counts or chemistry that reflect organ function.
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-1310
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-1310 Dose Level 5Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 5 on Day 1 of each cycle Q3W
Group II: DB-1310 Dose Level 4Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 4 on Day 1 of each cycle Q3W
Group III: DB-1310 Dose Level 3Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 3 on Day 1 of each cycle Q3W
Group IV: DB-1310 Dose Level 2Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 2 on Day 1 of each cycle Q3W
Group V: DB-1310 Dose Level 1Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W
Group VI: DB-1310 Dose Expansion 6Experimental Treatment1 Intervention
Enrolled Subject with other advanced/unresectable, or metastatic solid tumors who have progressed on or after standard systemic treatment, or for which no standard systemic treatment is available will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group VII: DB-1310 Dose Expansion 5Experimental Treatment1 Intervention
Enrolled Subjects with advanced/unresectable, or metastatic BC with HER2-positive (IHC3+, or IHC2+ and ISH+) who have progressed on or after HER2 targeted systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group VIII: DB-1310 Dose Expansion 4Experimental Treatment1 Intervention
Enrolled Subjects with advanced/unresectable, or metastatic HNSCC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group IX: DB-1310 Dose Expansion 3Experimental Treatment1 Intervention
Enrolled Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group X: DB-1310 Dose Expansion 2Experimental Treatment1 Intervention
Enrolled Subjects with advanced/unresectable, or metastatic NSCLC without EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group XI: DB-1310 Dose Expansion 1Experimental Treatment1 Intervention
Enrolled Subjects with advanced/unresectable, or metastatic adenocarcinoma NSCLC with EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Find a Location
Who is running the clinical trial?
DualityBio Inc.Lead Sponsor
7 Previous Clinical Trials
2,630 Total Patients Enrolled
Raymond Zhao, MDStudy DirectorDualityBio Inc.
1 Previous Clinical Trials
345 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study's procedures and risks, can consent in writing, and will follow the study requirements.I have active hepatitis.I agree not to freeze or donate sperm during and for 4 months after the study.I have at least one tumor that can be measured.I had a heart attack or unstable chest pain in the last 6 months.I am an adult and meet the age requirement for the trial.I agree to use birth control during and for months after the study.I have brain metastases that are untreated and causing symptoms.I will not donate or use my eggs for 7 months after the last study drug.I have a serious eye condition affecting my cornea.My organs are functioning well, as tested within the last week.I have completed the required waiting period after my last treatment.I have a history of serious heart issues, including heart failure or irregular heartbeat needing treatment.I have been treated with HER3 targeted therapy before.I have an infection that needs IV treatment.My cancer has worsened or didn't respond well to standard treatments.I have been treated with a specific cancer drug before, but not trastuzumab deruxtecan for a certain study group.I am fully active or restricted in physically strenuous activity but can do light work.I have or might have interstitial lung disease.I am willing to provide tumor samples for testing.I cannot or will not stop taking medications that may affect my heart's rhythm.
Research Study Groups:
This trial has the following groups:- Group 1: DB-1310 Dose Level 1
- Group 2: DB-1310 Dose Level 2
- Group 3: DB-1310 Dose Level 3
- Group 4: DB-1310 Dose Level 4
- Group 5: DB-1310 Dose Level 5
- Group 6: DB-1310 Dose Expansion 1
- Group 7: DB-1310 Dose Expansion 2
- Group 8: DB-1310 Dose Expansion 3
- Group 9: DB-1310 Dose Expansion 4
- Group 10: DB-1310 Dose Expansion 5
- Group 11: DB-1310 Dose Expansion 6
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.
Are there any current openings in this medical trial for patient participation?
"According to clinicaltrials.gov, the current recruitment for this trial has been suspended; its first posting was on April 7th 2023 and it last updated March 14th 2023. Nevertheless, 2,591 other studies are currently seeking volunteers."
Answered by AI
What aim does this medical experiment strive to attain?
"The key aim of this trial, to be monitored up until 21 days after Cycle 1 Day 1, is the Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0. Secondary objectives include an analysis of DB-1310's Maximum observed plasma concentration (Cmax), Time to Cmax and Terminal elimination half-life."
Answered by AI
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