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โ† Trials
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A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllDualityBio Inc.
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In plain words

What the trial is, and whether it could suit you

This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes one randomized dose expansion cohort and two single-arm dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. Male or female adults 2. Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments. 3. Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants. 4. Has a life expectancy of โ‰ฅ 3 months. 5. Has an ECOG PS of 0-1. 6. Has LVEF โ‰ฅ 50% within 28 days before enrollment. 7. Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication. 8. Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods Key Exclusion Criteria: 1. Prior treatment with ADAM9 targeted therapy. 2. Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor. 3. Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment. 4. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment. 5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG 6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 ms in males and females 7. Has a history of (non-infectious) ILD/pneumonitis 8. Has a lung-specific intercurrent clinically significant illness 9. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals. 10. Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B; 11. Known chronic, active, or uncontrolled hepatitis C 12. Has clinically significant corneal disease. 13. Has clinically active brain metastases 14. Has unresolved toxicities from previous anticancer therapy Concurrent malignancy \< 3 years. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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What it tests

  • DB-1317
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Where

14 sites
USA04-0
Los Angeles, United States
USA05-0
Ann Arbor, United States
Site USA06-0
Pittsburgh, United States
USA02-0
Houston, United States
USA03-0
San Antonio, United States
USA01-0
Fairfax, United States
AUS03-0
Liverpool, Australia
AUS01-0
Randwick, Australia

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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