DB-1303-O-1001
A Phase 1/2a, Multicenter, Open-Label, Non-Randomized First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303 in Patients With Advanced/Metastatic Solid Tumors. (DB-1303-O-1001)
Trial summary:
Dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303 in subjects with advanced solid tumors that express HER2.
Receptor status / problem studied:
Low HER2 expressing Breast Cancer and Endometrial Cancer
Inclusion criteria
- Has a pathologically documented HER2-positive or HER2-expressing advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- At least 1 measurable lesion (per RECIST 1.1)
- Provide signed informed consent
- ECOG performance status (PS) of 0-1.
- LVEF ≥ 50% by ECHO or MUGA
- Adequate organ functions
- Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
- Life expectancy of ≥ 3 months.
Exclusion criteria
- History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
- History of myocardial infarction or unstable angina within 6 months before Day 1.
- Average QTcF > 450 ms in males and > 470 ms in females
- History of clinically significant lung diseases
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- HIV infection with AIDS defining illness or active viral hepatitis.
- Clinically active brain metastases
- Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
- A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
- Part 2 only: Prior treatment with HER2 ADC agents except T-DM1, RC48-ADC
Open for recruitment
Trial Title
DB-1303-O-1001
Diagnosis
Breast cancer Endometrial cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
II
Locations
Investigators
Principal Investigator