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Trial Title:
A Study of DB-1202 Monotherapy in Advanced Solid Tumors
NCT ID:
NCT05785728
Condition:
Advanced Solid Tumor
Conditions: Keywords:
TGF-β
thyroid cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DB-1202
Description:
Administered I.V.
Arm group label:
DB-1202 Dose Expansion 1
Arm group label:
DB-1202 Dose Expansion 2
Arm group label:
DB-1202 Dose Expansion 3
Arm group label:
DB-1202 Dose Level 1
Arm group label:
DB-1202 Dose Level 2
Arm group label:
DB-1202 Dose Level 3
Arm group label:
DB-1202 Dose Level 4
Arm group label:
DB-1202 Dose Level 5
Arm group label:
DB-1202 Dose Level 6
Summary:
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and
tolerability of DB-1201 in subjects with advanced solid tumors.
Detailed description:
This is a multicenter, non-randomized, open-label, multiple-dose, FIH study. The study
consists of two parts: Part 1 adopts a rule based "3 + 3" design to identify MTD/RP2D;
Part 2 is a dose expansion phase to confirm the safety, tolerability and efficacy in
selected solid malignant tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female at least 18 years old.
2. Has histologically or cytologically confirmed metastatic or locally advanced solid
tumors for which no effective standard therapy existed or standard of care has
failed or is not considered as an option.
3. Is capable of comprehending study procedures and risks outlined in the informed
consent and is willing to provide written consent.
4. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
5. At least one measurable lesion as assessed by the investigator according to response
evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
6. Has adequate organ function within 7 days prior to initiation of the first Treatment
Cycle
7. Platelet count ≥ 100 000/mm3
8. Hemoglobin (Hb) ≥ 8.5 g/dL
9. Absolute neutrophil count (ANC) ≥ 1500/mm3
10. Creatinine ≤ 1.5 × upper limit of normal (ULN), or
11. Creatinine clearance ≥ 60 mL/min (modification Cockcroft-Gault equation)
Exclusion Criteria:
1. Has a medical history of symptomatic chronic heart failure (CHF) (New York Heart
Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
2. Has a medical history of myocardial infarction or unstable angina within 6 months
before Day 1.
3. Has a QTc prolongation to > 470 millisecond (ms) based on a 12-lead
electrocardiogram (ECG) in triplicate.
4. Active or prior documented autoimmune disease within the past 2 years. NOTE:
Subjects with a history of autoimmune thyroid disease are not excluded. Subjects
with vitiligo or psoriasis not requiring systemic treatment (within the past 2
years) are not excluded.
5. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease,
ulcerative colitis).
6. History of primary immunodeficiency.
7. History of allogeneic organ transplant.
8. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or
antifungals.
9. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C
infection.
10. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding
will also be excluded), or pregnant as confirmed by pregnancy tests performed within
7 days prior to initiation of the first Treatment Cycle.
11. Male and female subjects who are unwilling to use adequate contraceptive methods
(double barrier or intrauterine contraceptive) during the study and for at least 7
months after the last dose of study drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200120
Country:
China
Contact:
Last name:
Jian Zhang, PhD
Email:
Syner2000@163.com
Start date:
June 28, 2023
Completion date:
February 28, 2024
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/NCT05785728
