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Monoclonal Antibodies
DB-1303 for Solid Cancers
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
Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
ECOG performance status (PS) of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to follow-up period, approximately 1 year post-treatment
Awards & highlights
Study Summary
This trial is testing a new drug, DB-1303, to see if it is safe and works well against HER2-expressing solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that are HER2-positive or express HER2, and have not responded to standard treatments or have no standard options left. Participants must be relatively healthy (ECOG 0-1), have a life expectancy of at least 3 months, a functioning heart (LVEF ≥ 50%), and adequate organ function.Check my eligibility
What is being tested?
The study tests DB-1303's safety and effectiveness in different doses for those with specific types of advanced cancer. It includes other drugs like Itraconazole, Pertuzumab Injection, Ritonavir as part of the treatment regimen in a Phase 1/2a setting.See study design
What are the potential side effects?
Possible side effects may include reactions related to the immune system, liver or kidney issues due to drug interactions, heart problems from Pertuzumab Injection, and general symptoms like nausea or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is HER2-positive or expresses HER2, is advanced, and doesn't respond to standard treatments.
Select...
I am fully active or can carry out light work.
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
Phase 1: Maximum Tolerated Dose (MTD) of DB-1303
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 outcome measures
Phase 1 & 2: Disease Control Rate (DCR) as assessed by RECIST 1.1
Phase 1 & 2: Duration of Response (DoR) as assessed by RECIST 1.1
Phase 1 & 2: Time to Response (TTR) as assessed by RECIST 1.1
+10 moreTrial Design
20Treatment groups
Experimental Treatment
Group I: DB-1303 Dose Level 7Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 7 on Day 1 of each cycle Q3W
Group II: DB-1303 Dose Level 6Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 6 on Day 1 of each cycle Q3W
Group III: DB-1303 Dose Level 5Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 5 on Day 1 of each cycle Q3W
Group IV: DB-1303 Dose Level 4Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 4 on Day 1 of each cycle Q3W
Group V: DB-1303 Dose Level 3Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 3 on Day 1 of each cycle Q3W
Group VI: DB-1303 Dose Level 2Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 2 on Day 1 of each cycle Q3W
Group VII: DB-1303 Dose Level 1Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 1 on Day 1 of each cycle Q3W
Group VIII: DB-1303 Dose Expansion 9Experimental Treatment1 Intervention
Enrolled Subjects will be randomized to receive a single-dose of DB-1303 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W
Group IX: DB-1303 Dose Expansion 8Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group X: DB-1303 Dose Expansion 7Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group XI: DB-1303 Dose Expansion 6Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group XII: DB-1303 Dose Expansion 5Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group XIII: DB-1303 Dose Expansion 4Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group XIV: DB-1303 Dose Expansion 3Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group XV: DB-1303 Dose Expansion 2Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group XVI: DB-1303 Dose Expansion 13Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group XVII: DB-1303 Dose Expansion 12Experimental Treatment2 Interventions
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W
Group XVIII: DB-1303 Dose Expansion 11Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Group XIX: DB-1303 Dose Expansion 10Experimental Treatment3 Interventions
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir and itraconazole to assess the DDI potential
Group XX: DB-1303 Dose Expansion 1Experimental Treatment1 Intervention
Enrolled Subjects will be randomized to receive a single-dose of DB-1303 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritonavir
2005
Completed Phase 4
~2200
Itraconazole
2017
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
DualityBio Inc.Lead Sponsor
7 Previous Clinical Trials
2,286 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious heart failure or heart rhythm problems needing treatment.I haven't had a heart attack or unstable chest pain in the last 6 months.I am fully active or can carry out light work.I don't have lasting side effects from cancer treatment worse than mild.My cancer is HER2-positive or expresses HER2, is advanced, and doesn't respond to standard treatments.My cancer is HER2 positive and has not responded to standard treatments.I can provide a HER2 status report or a sample of my tumor.I am fully active or can carry out light work.I have active brain tumors.My organs are functioning well.I have a history of serious lung problems.I haven't had any cancer except skin cancer or treated in-situ disease in the last 3 years.I do not have an infection needing IV drugs.I have HIV with AIDS or active hepatitis.
Research Study Groups:
This trial has the following groups:- Group 1: DB-1303 Dose Level 6
- Group 2: DB-1303 Dose Expansion 13
- Group 3: DB-1303 Dose Expansion 8
- Group 4: DB-1303 Dose Expansion 7
- Group 5: DB-1303 Dose Level 1
- Group 6: DB-1303 Dose Level 4
- Group 7: DB-1303 Dose Level 7
- Group 8: DB-1303 Dose Level 2
- Group 9: DB-1303 Dose Expansion 6
- Group 10: DB-1303 Dose Expansion 4
- Group 11: DB-1303 Dose Level 3
- Group 12: DB-1303 Dose Level 5
- Group 13: DB-1303 Dose Expansion 1
- Group 14: DB-1303 Dose Expansion 9
- Group 15: DB-1303 Dose Expansion 2
- Group 16: DB-1303 Dose Expansion 3
- Group 17: DB-1303 Dose Expansion 5
- Group 18: DB-1303 Dose Expansion 10
- Group 19: DB-1303 Dose Expansion 11
- Group 20: DB-1303 Dose Expansion 12
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.
Solid Tumors Patient Testimony for trial: Trial Name: NCT05150691 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being accepted for this clinical experiment at present?
"Per the information on clinicaltrials.gov, this medical trial is still recruiting participants and has been since it was published in January of 2022. The details were last updated by the research team in November of that same year."
Answered by AI
How many participants is this clinical trial accepting?
"Indeed, according to clinicaltrials.gov, this medical trial is actively seeking participants. First advertised on the 31st of January 2022 and last edited on November 4th 2022, 360 patients need to be recruited from 7 distinct sites."
Answered by AI
What key goals is this trial working towards accomplishing?
"The primary end-point that will be monitored for the duration of this study (roughly 12 months) is Serious Adverse Events as assessed by CTCAE v5.0. Secondary objectives include Pharmacokinetic-Ctrough, Overall Survival using RECIST 1.1, and Progression Free Survival determined via RECIST V1.1 measurements."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Ohio
Florida
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
BRCR Medical Center Inc.
D&H Cancer Research Center LLC
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I believe in trials and God.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 1 Day
Most responsive sites:
- BRCR Medical Center Inc.: < 24 hours
Typically responds via
Phone Call
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