RECRUITING

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

Conditions

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 ESCC BTC

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-04-10

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05785741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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.	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.

Inclusion Criteria

Exclusion Criteria

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.

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.

Contacts and Locations

Study Contact

Jenny Li

CONTACT

1-650-237-9339

jenny.li@dualitybiologics.com

Junhua Gao

CONTACT

wei.wang@dualitybiologics.com

Principal Investigator

Lily Hu

STUDY_DIRECTOR

DualityBio Inc.

Study Locations (Sites)

University of California, Davis Comprehensive Cancer Center

Sacramento, California, 95817

United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, 90404

United States

D&H Cancer Research Center LLC

Margate, Florida, 33063

United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827

United States

BRCR global

Plantation, Florida, 33322

United States

Florida Cancer Specialists

Sarasota, Florida, 34232

United States

BRCR Medical Center Inc.

Tamarac, Florida, 33321

United States

Research Site 111

Atlanta, Georgia, 30322

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center

Cincinnati, Ohio, 45219

United States

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: DualityBio Inc.

Lily Hu, STUDY_DIRECTOR, DualityBio Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-10

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-04-10

Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

HER3
NSCLC
CRPC
HNSCC
BC
non-small cell lung cancer
castration-resistant prostate cancer
head and neck squamous cell carcinoma
breast cancer
ESCC
BTC

Additional Relevant MeSH Terms

Advanced Solid Tumor