Phase I Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors

What is the Purpose of this Study?

The purpose of this Phase 1 study is to assess the safety and tolerability of an experimental drug called DB-1317 in patients with an advanced/metastatic (cancer that has spread from its original site) solid tumor for which there is no standard treatment available. DB-1317 is a type of drug known as an antibody-drug conjugate (ADC), a type of targeted therapy that delivers anti-cancer drugs directly to cancer cells. The study will also assess the anti-cancer activity of DB-1317, measure the amount of the drug in the patient’s blood at various time points, and determine whether the body makes antibodies against DB-1317. Additionally, the study may look into the relationship between biomarkers (biological molecules in blood or tissue that may be a sign of a disease) in the body. This study will accept patients with no standard options and any tumor type.

Eligibility

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 ≥ 3 months.

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 ≥ 3 months.
5. Has an ECOG PS of 0-1.
6. Has LVEF ≥ 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.

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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute : Marquis Keene, Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants with Selected Advanced/Metastatic Solid Tumors

Study Details

Disease Type/Condition

Anus, Breast, Colon, Liver, Lung, Pancreas, Prostate, Rectum

Principal Investigator

Hamid, Omid

Co-Investigators

Cathie T Chung, Erwin Grussie, Inderjit Mehmi, Iryna Singh, Justin Moyers, Kristopher Wentzel

Age Group

Adult

Phase

IRB Number

STUDY00004474

ClinicalTrials.gov ID

NCT07141706

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org