Trial Title:
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
NCT ID:
NCT06554795
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DB-1419
Description:
Administered Injection of Vein (I.V.)
Arm group label:
Dose Expansion 1
Arm group label:
Dose Expansion 2
Arm group label:
Dose Expansion 3
Arm group label:
Dose Expansion 4
Arm group label:
Dose Expansion 5
Arm group label:
Dose Expansion 6
Arm group label:
Dose Expansion 7
Arm group label:
Dose Expansion 8
Arm group label:
Dose Level 1
Arm group label:
Dose Level 2
Arm group label:
Dose Level 3
Arm group label:
Dose Level 4
Arm group label:
Dose Level 5
Arm group label:
Dose Level 6
Summary:
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors
Detailed description:
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety,
Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in
Participants with Advanced/Metastatic Solid Tumors
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adults aged ≥ 18 years at the time of voluntarily signing informed consent.
2. Histologically or cytologically confirmed unresectable advanced/metastatic solid
tumor that has relapsed or progressed on or after standard systemic treatments, or
refused the standard treatment, or for which no standard treatment is available.
3. At least one measurable lesion as assessed by the Investigator according to RECIST
v1.1 criteria (Only applicable to backfill participants in phase 1a and participants
in phase 1b/2a). CRPC participants with bone-only disease may be eligible on a
case-by-case basis after discussion with the Medical Monitor.
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 function within 7 days prior to the first dose of study
treatment.
8. Has adequate treatment washout period prior to the first dose of study treatment.
9. Is willing to provide pre-existing resected tumor samples when available or undergo
fresh tumor biopsy if feasible for the measurement of B7-H3/PD-L1 level and other
biomarkers if no contraindication.
Note: there is no minimum B7-H3/PD-L1 expression level mandatory for entry into the
study.
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.
Exclusion Criteria:
1. Prior treatment with B7-H3 targeted therapy.
2. Has a medical history of symptomatic congestive heart failure (New York Heart
Association [NYHA] classes II-IV or serious cardiac arrhythmia requiring treatment.
3. Has a medical history of myocardial infarction or unstable angina within 6 months
before enrollment.
4. 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.
5. Has a medical history of interstitial lung diseases (e.g., non-infectious
interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation
pneumonitis which needs glucocorticoids and antibiotics) or current interstitial
lung diseases or who are suspected to have these diseases by imaging at screening.
6. Has a history of underlying pulmonary disorder including, but not limited to,
pulmonary emboli within 3 months of the start of study treatment, severe asthma,
severe COPD, restrictive lung disease, and other clinically significant pulmonary
compromise or requirement for supplemental oxygen.
7. Has an active autoimmune disease that has required systemic treatment in past 2
years (i.e., with use of disease modifying agents, corticosteroids, or
immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is allowed.
8. Has an uncontrolled infection requiring intravenous injection of antibiotics,
antivirals, or antifungals within 2 weeks before first dose of study treatment.
9. Know human immunodeficiency virus (HIV) infection.
10. Has spinal cord compression or clinically active central nervous system (CNS)
metastases, defined as untreated and symptomatic, or requiring therapy with
corticosteroids or anticonvulsants to control associated symptoms. Participants with
asymptomatic CNS metastases who are radiologically and neurologically stable for at
least 4 weeks following CNS-directed therapy (defined as 2 brain images, same
imaging modality, both of which are obtained after treatment to the brain
metastases; these imaging scans should be obtained at least 4 weeks apart and show
no evidence of intracranial progression), and 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:
Site USA08-0
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Site USA06-0
Address:
City:
Washington, D.C.
Zip:
20007
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Site USA02
Address:
City:
Florida City
Zip:
32827
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Site USA04-0
Address:
City:
Edison
Zip:
08837
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Site USA03
Address:
City:
Carolina
Zip:
28078
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Site USA05-0
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Site USA07-0
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
AUS03-0
Address:
City:
North Ryde
Zip:
2109
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
AUS01-0
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
AUS02-0
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jennifer Senior Clinical Trial Coordinator
Phone:
08-6382-5100
Email:
jmarks@linear.org.au
Facility:
Name:
Site CHN08-0
Address:
City:
Ha'erbin
Zip:
150001
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site CHN03-0
Address:
City:
Luoyang
Zip:
471000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site CHN06-0
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site CHN13-0
Address:
City:
Changchun
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site CHN01-0
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site CHN05-0
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site CHN09-0
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Start date:
September 3, 2024
Completion date:
February 2027
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/NCT06554795
