Trial Title:
A Study of DB-1310 in Advanced/Metastatic Solid Tumors
NCT ID:
NCT05785741
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Trastuzumab
Osimertinib
Conditions: Keywords:
HER3
NSCLC
CRPC
HNSCC
BC
non-small cell lung cancer
castration-resistant prostate cancer
head and neck squamous cell carcinoma
breast cancer
ESCC
BTC
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DB-1310
Description:
Administered I.V.
Arm group label:
DB-1310 Dose Expansion 1
Arm group label:
DB-1310 Dose Expansion 10
Arm group label:
DB-1310 Dose Expansion 11
Arm group label:
DB-1310 Dose Expansion 2
Arm group label:
DB-1310 Dose Expansion 3
Arm group label:
DB-1310 Dose Expansion 4
Arm group label:
DB-1310 Dose Expansion 5
Arm group label:
DB-1310 Dose Expansion 6
Arm group label:
DB-1310 Dose Expansion 7
Arm group label:
DB-1310 Dose Expansion 8
Arm group label:
DB-1310 Dose Expansion 9
Arm group label:
DB-1310 Dose Level 1
Arm group label:
DB-1310 Dose Level 10
Arm group label:
DB-1310 Dose Level 11
Arm group label:
DB-1310 Dose Level 2
Arm group label:
DB-1310 Dose Level 3
Arm group label:
DB-1310 Dose Level 4
Arm group label:
DB-1310 Dose Level 5
Arm group label:
DB-1310 Dose Level 6
Arm group label:
DB-1310 Dose Level 7
Arm group label:
DB-1310 Dose Level 8
Arm group label:
DB-1310 Dose Level 9
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
Administered I.V.
Arm group label:
DB-1310 Dose Expansion 5
Arm group label:
DB-1310 Dose Level 10
Arm group label:
DB-1310 Dose Level 11
Arm group label:
DB-1310 Dose Level 9
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Administered I.V.
Arm group label:
DB-1310 Dose Expansion 7
Arm group label:
DB-1310 Dose Expansion 8
Arm group label:
DB-1310 Dose Level 6
Arm group label:
DB-1310 Dose Level 7
Arm group label:
DB-1310 Dose Level 8
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.
Detailed description:
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts
the standard "3+3" design to identify: the MTD and/or RP2D of DB-1310 as monotherapy, the
RCD_A of DB-1310 in combination with trastuzumab and the RCD_B of DB-1310 in combination
with Osimertinib; 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 or in combination with Osimertinib.
Criteria for eligibility:
Criteria:
Inclusion 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.
Exclusion Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Davis Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Tianhong Li, PhD
Facility:
Name:
UCLA Hematology/Oncology - Santa Monica
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aaron E. Lisberg, MD
Facility:
Name:
D&H Cancer Research Center LLC
Address:
City:
Margate
Zip:
33063
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Kahn, MD
Facility:
Name:
Sarah Cannon Research Institute at Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cesar Batista, MD
Facility:
Name:
BRCR global
Address:
City:
Plantation
Zip:
33322
Country:
United States
Status:
Recruiting
Contact:
Last name:
H Amin, MD
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Judy SZ Wang, MD
Facility:
Name:
BRCR Medical Center Inc.
Address:
City:
Tamarac
Zip:
33321
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chintan Gandhi
Facility:
Name:
Research Site 111
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julia Rotow, MD
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Weise, DO
Facility:
Name:
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexander Starodub, MD, PhD
Facility:
Name:
Tennessee Oncology, PLLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erika P. Hamilton, MD
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
A Spira, MD
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qiming Wang
Facility:
Name:
Hunan cancer hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Wu
Facility:
Name:
Jiangsu Province hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong mei Yin
Facility:
Name:
Affiliated Hospital of Jiangnan University
Address:
City:
Wuxi
Zip:
214000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Mao
Facility:
Name:
The first hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiuwei Cui
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110010
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming fang Zhao
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shun Lu
Facility:
Name:
Sichuan Provincial People's Hospital
Address:
City:
Chendu
Zip:
610030
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Lan
Start date:
April 10, 2023
Completion date:
August 31, 2026
Lead sponsor:
Agency:
DualityBio Inc.
Agency class:
Industry
Source:
DualityBio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05785741
