RecruitingSolid Tumor, Adult

First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors

Sponsor: DualityBio Inc.

You may qualify if…

✓ 1. Adults aged ≥ 18 years at the time of voluntarily signing informed consent.
✓ 2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.
✓ 3. At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b/2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor.
✓ 4. Has a life expectancy of ≥ 3 months.
✓ 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
✓ 6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
✓ 7. Has adequate organ function within 7 days prior to the first dose of study treatment.
✓ 8. Has adequate treatment washout period prior to the first dose of study treatment.

You may not qualify if…

✕ 1. Prior treatment with B7-H3 targeted therapy or prior treatment with ADC containing a topoisomerase I inhibitor payload.
✕ 2. Has a medical history of symptomatic congestive heart failure (New York Heart Association \[NYHA\] classes II-IV or serious cardiac arrhythmia requiring treatment.
✕ 3. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
✕ 4. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.
✕ 5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
✕ 6. Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.
✕ 7. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
✕ 8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals within 2 weeks before first dose of study treatment.