A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or … (NCT06118333) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma(PANKU-NPC01)
China386 participantsStarted 2023-12-04
Plain-language summary
A phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic nasopharyngeal carcinoma who had failed at least two lines of platinum-based chemotherapy after receiving PD-1/PD-L1 monoclonal antibody as the last line of therapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign the informed consent form and comply with the protocol requirements;
✓. Age ≥18 years and ≤75 years;
✓. Expected survival time ≥3 months;
✓. Patients with recurrent or metastatic nasopharyngeal carcinoma confirmed by histology or cytology, who have failed treatment with PD-1/PD-L1 monoclonal antibodies and at least two lines of chemotherapy (including at least one platinum-based regimen);
✓. Patients with recurrent or metastatic nasopharyngeal carcinoma suitable for receiving the control group chemotherapy drugs specified in this protocol as the last-line treatment;
✓. Must have at least one measurable lesion as defined by RECIST v1.1;
✓. ECOG performance status score of 0 or 1;
✓. Toxicity from prior anti-tumor treatment has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
Exclusion criteria
✕. Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives before randomization, or palliative radiotherapy and antitumor therapy within 2 weeks;
✕. Patients with recurrent nasopharyngeal carcinoma suitable for curative-intent local treatment (surgery or radiotherapy) should be excluded;
✕. Prior treatment with ADC drugs containing topoisomerase I inhibitor as the small-molecule toxin, or ADC drugs targeting EGFR and/or HER3;