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DB-1202 for Advanced Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by DualityBio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has histologically or cytologically confirmed metastatic or locally advanced solid tumors for which no effective standard therapy existed or standard of care has failed or is not considered as an option.
Has an Eastern Cooperative Oncology Group performance status (ECOG 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 tests a new cancer drug to see if it's safe and effective for treating advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors, who are in good physical condition (ECOG PS 0-1), have proper organ function, and at least one measurable tumor lesion. They must not have severe heart issues, bowel inflammation like Crohn's disease or ulcerative colitis, recent heart attacks, certain infections including HIV and hepatitis B/C, or be pregnant/breastfeeding. Participants should agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing DB-1202 as a single treatment for advanced solid tumors. It's an early-stage study (Phase 1/2a) that will first find the safest dose of DB-1202 (dose escalation) and then see how well it works at that dose (dose expansion).See study design
What are the potential side effects?
While specific side effects of DB-1202 aren't listed here since it's a new drug being tested, common side effects from cancer drugs can include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer has no effective standard treatment options left.
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
Maximum Tolerated Dose (MTD) of DB-1202
Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) 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
9Treatment groups
Experimental Treatment
Group I: DB-1202 Dose Level 6Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 6 on Day 1 of each cycle Q3W
Group II: DB-1202 Dose Level 5Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 5 on Day 1 of each cycle Q3W
Group III: DB-1202 Dose Level 4Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 4 on Day 1 of each cycle Q3W
Group IV: DB-1202 Dose Level 3Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 3 on Day 1 of each cycle Q3W
Group V: DB-1202 Dose Level 2Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 2 on Day 1 of each cycle Q3W
Group VI: DB-1202 Dose Level 1Experimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 1 on Day 1 of each cycle Q3W
Group VII: DB-1202 Dose Expansion 3Experimental Treatment1 Intervention
Enrolled Subjects in selected solid malignant tumors can be added will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D.
Group VIII: DB-1202 Dose Expansion 2Experimental Treatment1 Intervention
Enrolled Subjects in selected solid malignant tumors can be added will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D.
Group IX: DB-1202 Dose Expansion 1Experimental Treatment1 Intervention
Enrolled Subjects with locally advanced or metastatic primary thyroid cancers with pathology of epithelial tumors that originated from thyroid follicular cells will be enrolled regardless of PD-L1 expression will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D.
Find a Location
Who is running the clinical trial?
DualityBio Inc.Lead Sponsor
7 Previous Clinical Trials
2,767 Total Patients Enrolled
Raymond ZhaoStudy DirectorDualityBio Inc.
3 Previous Clinical Trials
1,036 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack or unstable chest pain in the last 6 months.I am not pregnant or breastfeeding.Your hemoglobin level is at least 8.5 g/dL.Your absolute neutrophil count is at least 1500/mm3.Creatinine levels are at or below 1.5 times the maximum permissible value.Your creatinine clearance is 60 mL/min or higher, as calculated by the Cockcroft-Gault equation.I have HIV or active hepatitis B or C.I have had an autoimmune disease in the last 2 years, but not thyroid issues, vitiligo, or psoriasis without systemic treatment.I have or had Crohn's disease or ulcerative colitis.I am currently receiving IV treatment for an uncontrolled infection.I have a history of serious heart issues, including heart failure or irregular heartbeat that needs treatment.I am willing to use effective birth control during and for 7 months after the study.I am fully active or can carry out light work.My organs are functioning well enough for treatment.You have received an organ transplant from another person in the past.Your platelet count is greater than or equal to 100 000/mm3.I am 18 years old or older.I understand the study's procedures and risks and agree to participate.You have at least one measurable lesion as judged by the investigator in accordance with RECIST version 1.1 guidelines.My advanced cancer has no effective standard treatment options left.
Research Study Groups:
This trial has the following groups:- Group 1: DB-1202 Dose Expansion 1
- Group 2: DB-1202 Dose Level 5
- Group 3: DB-1202 Dose Level 4
- Group 4: DB-1202 Dose Expansion 3
- Group 5: DB-1202 Dose Level 2
- Group 6: DB-1202 Dose Level 6
- Group 7: DB-1202 Dose Expansion 2
- Group 8: DB-1202 Dose Level 3
- Group 9: DB-1202 Dose Level 1
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.
Is this research initiative actively seeking volunteers?
"Judging by clinicaltrials.gov, this medical trial is not currently looking for participants although it was initially posted on June 28th 2023 and recently updated on March 14th 2023. However, there are 480 other trials in progress that require volunteers at the moment."
Answered by AI
What outcomes is this trial hoping to attain?
"The primary assessment of this experiment, which is to be conducted over a three week period beginning on Cycle 1 Day 1, will measure the percentage of participants with Serious Adverse Events. There are also secondary objectives including Cmax (maximum observed plasma concentration) and T1/2 (terminal elimination half-life)."
Answered by AI
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