Status and phase
Conditions
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About
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
Full description
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD and/or RP2D. Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1311/BNT324 as monotherapy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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).
Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment; or for which no standard treatment is available.
At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria (measurable disease as defined by RANO 2.0 criteria for GBM subjects). Castrate-resistant prostate cancer (CRPC) subjects with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.
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 function 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 B7-H3 level and other biomarkers if no contraindication.
Note: there is no minimum B7-H3 expression level mandatory for entry into the study.
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.
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.
SCLC subjects (Phase 2a Cohort 1 ONLY):
NSCLC subjects (Phase 2a Cohort 2 ONLY):
ESCC subjects (Phase 2a Cohort 3 ONLY):
CRPC subjects (Phase 2a Cohort 4 ONLY):
Melanoma subjects (Phase 2a Cohort 5 ONLY)
• Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy, must have had either:
HCC subjects (Phase 2a Cohort 6 ONLY)
Note: Subjects basically should receive prior standard therapy.
Cervical cancer subjects (Phase 2a Cohort 7 ONLY)
Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and:
Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either:
d. paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or e. paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or f. paclitaxel + topotecan + bevacizumab + anti-PD-(L)1 agent Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the subject was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required.
Has received 1 or 2 prior systemic therapy regimens for recurrent or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for recurrent or metastatic cervical cancer should be counted.
Subjects with other solid tumors (Phase 2a Cohort 8 ONLY)
HNSCC subjects (Phase 2a Cohort 9 and Cohort 13)
Subjects with rare tumors (Phase 2a Cohort 10 ONLY) Histologically or cytologically confirmed rare tumor types. Progressed or relapsed after at least one prior standard therapeutic regimen (Patients who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving DB-1311/BNT324 are available prior to consenting to participate in this trial).
Post lutetium-177 CRPC subjects (Phase 2a Cohort 11 ONLY):
Pathologically documented metastatic adenocarcinoma of the prostate cancer. Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease as defined by PCWG3 criteria.
Taxane-naive CRPC subjects (Phase 2a Cohort 12 ONLY) • Pathologically documented metastatic adenocarcinoma of the prostate cancer. Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease as defined by PCWG3 criteria.
Exclusion criteria
Unless otherwise specified, the exclusion criteria are common to both Phase 1 and Phase 2a. Subjects who meet any of the following criteria will be excluded from the study:
Primary purpose
Allocation
Interventional model
Masking
610 participants in 18 patient groups
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Central trial contact
Tianna Zhao; Ling Li
Data sourced from clinicaltrials.gov
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