A Study of DB-1310 in Advanced/Metastatic Solid Tumors
Breast Cancer
Head and Neck Cancer
Lung Cancer
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
DB-1310-O-1001 (primary)
NCI-2023-06649
CTR20231736
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.
Objectives
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 or approved trastuzumab biosimilar 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 approved
trastuzumab biosimilar or in combination with Osimertinib.
Eligibility
- 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).
- 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.
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
- Has a life expectancy of = 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Has LVEF = 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
- Has adequate organ functions within 7 days prior to Day 1 of Cycle 1.
- Has adequate treatment washout period prior to Day 1 of Cycle 1.
- 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. For HER2 IHC 0 breast cancer subjects, it is highly recommended to collect additional tumor sample (Refer to Lab Manual).
- 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.
- 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. Females must be using highly effective contraceptive measures during the study and for at least 7 months after the last dosing of study drug, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
- Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- 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.
- 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.
Treatment Sites in Georgia
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