DB-1419 for Advanced/Metastatic Solid Tumors
This study is testing a new drug called DB-1419 for people with advanced or metastatic (spread to other parts of the body) solid tumors. You might be able to join if your cancer has come back, gotten worse after standard treatments, or if there are no other standard treatments available. The main goals are to see how safe DB-1419 is, what side effects it causes, and to find the highest dose that can be given safely. The study is currently recruiting, with a plan to enroll up to 360 adult participants.
- Study design
- This is a Phase 1/2a, multicenter, open-label study, meaning both you and your doctors will know you are receiving DB-1419. It plans to enroll up to 360 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 90 days after your last study treatment or before starting new anticancer treatment, whichever comes first.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
At a glance
Conditions
NCT06554795
Where you'd take part
This study runs at 36 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
AUS02-0
Nedlands, Washington, Australiastudy coordinator listed
Recruiting
AUS01-0
Randwick, New South Wales, Australiano site contact published
Recruiting
AUS03-0
North Ryde, New South Wales, Australiano site contact published
Recruiting
Site CHN01-0
Shanghai, Shanghai Municipality, Chinano site contact published
Recruiting
Site CHN03-0
Luoyang, Henan, Chinano site contact published
Recruiting
Site CHN08-0
Harbin, Heilongjiang, Chinano site contact published
Recruiting
Site CHN09-0
Zhengzhou, Henan, Chinano site contact published
Not yet recruiting
Site CHN13-0
Jilin City, Changchun, Chinano site contact published
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Lily Hu · STUDY_DIRECTOR · DualityBio Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE)Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Percentage of participants with TEAEs graded according to NCI CTCAE v5.0
- Phase 1/2a: Percentage of Participants with serious AE (SAE)Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Percentage of participants with SAEs graded according to NCI CTCAE v5.0
- Phase 1a: Maximum Tolerated Dose (MTD)From first study treatment administration until the initiation of Phase1b/2a, approximately up to 12 months.
MTD on the data collected during Part 1
- Phase 1a: Recommended Phase 2 Dose (RP2D)From first study treatment administration until the initiation of Phase 1b/2a, approximately up to 12 months.
RP2D of DB-1419 based on the data collected during Part 1
- Phase 1b/2a: Objective Response Rate (ORR) determined by Investigator per RECIST v1.1Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.
The percentage of subjects with best overall response of CR and PR