Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCLA
Dates
study started
completion around

Description

Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.

Official Title

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic Solid Tumors

Details

This is a multicenter, non-randomized, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts the standard "3+3" design to identify the MTD and/or RP2D; Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1310 as monotherapy or in combination with trastuzumab.

Keywords

Advanced Solid Tumor, HER3, NSCLC, CRPC, HNSCC, BC, non-small cell lung cancer, castration-resistant prostate cancer, head and neck squamous cell carcinoma, breast cancer, Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
  2. Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.
  3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria. Subjects with nonmeasurable disease only are allowed in Cohort 2c of Phase 2a.
  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 functions within 7 days prior to Day 1 of Cycle 1.
  8. Has adequate treatment washout period prior to Day 1 of Cycle 1.
  9. Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of HER3 level and other biomarkers if no contraindication.

    10. Is capable of comprehending study procedures and risks outlined in the informed

    consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.

    11. Male and female subjects of reproductive/childbearing potential must agree to use

    adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months after the last dose of study drug, respectively.

    12. Male subjects must not freeze or donate sperm starting at screening and throughout the

    study period, and at least 4 months after the final study drug administration.

    13. Female subjects must not donate, or retrieve for their own use, ova from the time of

    screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.

You CAN'T join if...

  1. Prior treatment with HER3 targeted therapy.
  2. Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (exclusive of trastuzumab deruxtecan for Cohort 2e of Phase 2a).
  3. Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) 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 electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250 milliseconds (ms).
  6. 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.
  7. Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval.
  8. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
  9. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.

    10. Has clinically significant corneal disease. 11. Know human immunodeficiency virus (HIV) infection. 12. Subjects have active viral (any etiology) hepatitis are excluded. However, subjects

    with positive hepatitis B surface antigen (HBsAg) who have the HBV DNA (viral load) below the lower limit quantification or HBV DNA titer < 1000 cps/mL or 200 IU/mL per local testing and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor. However, subjects with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have the HCV RNA below the lower limit of quantification per local testing are eligible for study entry.

    13. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding

    will also be excluded), or pregnant as confirmed by serum pregnancy tests performed within 7 days prior to Cycle 1 Day 1.

    14. Has clinically active brain metastases, defined as untreated and symptomatic, or

    requiring therapy with steroids or anticonvulsants to control associated symptoms. However, subjects with asymptomatic central nervous system (CNS) metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy, and who are on stable or decreasing doses of corticosteroids equivalent to ≤10 mg/day prednisone are eligible for study entry.

    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • University of California, Davis Comprehensive Cancer Center not yet accepting patients
    Sacramento California 95817 United States
  • UCLA Hematology/Oncology - Santa Monica accepting new patients
    Santa Monica California 90404 United States
  • Tennessee Oncology, PLLC accepting new patients
    Nashville Tennessee 37203 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
DualityBio Inc.
ID
NCT05785741
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 287 study participants
Last Updated