A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Recruiting
Phase 1
Phase 2
Interventional Study
HER2-positive Advanced Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 796 (estimated)
- Sponsor
- DualityBio Inc. · Industry
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About This Trial
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 stand…
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