Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0HEAGN)
ADC Name
DB-1202
Synonyms
DB-1202
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Organization
Duality Biotherapeutics (DualityBio) (Originator)
Drug Status
Phase 1/2 (discontinued)
Antibody Name
Undisclosed
Antigen Name
Undisclosed
Payload Name
Undisclosed
Payload Target
Undisclosed
Linker Name
Undisclosed
Conjugate Type
Undisclosed
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Disease Name Phase 1 Phase 2 Phase 3 Approved
Unspecific solid tumor
1 Trials
Clinical trial identifier
NCT05785728
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT05785728
PHASE1|||PHASE2
Phase 1/2, Multicenter, Open-label, First-in-human Study of DB-1202 Monotherapy in Patients With Advanced Solid Malignant Tumors to Evaluate the Tolerability, Safety, Pharmacokinetics and Antitumor Activity

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Undisclosed  NCT05785728
Phase 1/2
Phase 1/2, multicenter, open-label, first-in-human study of DB-1202 monotherapy in patients with advanced solid malignant tumors to evaluate the tolerability, safety, pharmacokinetics and antitumor activity.

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible subjects must be ≥18 years with advanced solid tumors (RECIST 1.1 measurable), ECOG 0-1, and adequate organ function. Key exclusions include cardiac dysfunction (NYHA II-IV, recent MI/unstable angina), active autoimmune/inflammatory diseases, uncontrolled infections, HIV/HBV/HCV, pregnancy/lactation, or unwillingness to use contraception.

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Administration Dosage
Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 1 on Day 1 of each cycle Q3W
Related Clinical Trial
NCT Number NCT05785728  Clinical Status PHASE1|||PHASE2
Clinical Description Phase 1/2, Multicenter, Open-label, First-in-human Study of DB-1202 Monotherapy in Patients With Advanced Solid Malignant Tumors to Evaluate the Tolerability, Safety, Pharmacokinetics and Antitumor Activity
Primary Endpoint
The study evaluates safety through DLTs (21 days post-Cycle 1), TEAEs/SAEs (CTCAE v5.0) over 1 year, and determines MTD/RP2D of DB-1202 in Phase 1, while Phase 2a assesses TEAEs/SAEs and ORR (RECIST 1.1) over 1 year.
Other Endpoint
Pharmacokinetic parameters (AUC, Cmax, Tmax, T1/2) of DB-1202 are analyzed within 8 treatment cycles (21-day cycles) across both Phase 1 and Phase 2a.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT05785728  Clinical Status Phase 1/2
Clinical Description Phase 1/2, multicenter, open-label, first-in-human study of DB-1202 monotherapy in patients with advanced solid malignant tumors to evaluate the tolerability, safety, pharmacokinetics and antitumor activity.
References
Ref 1 A Study of DB-1202 Monotherapy in Advanced Solid Tumors
Ref 2 Phase 1/2, Multicenter, Open-label, First-in-human Study of DB-1202 Monotherapy in Patients With Advanced Solid Malignant Tumors to Evaluate the Tolerability, Safety, Pharmacokinetics and Antitumor Activity, NCT05785728