JS207 a Bispecific Antibody Against PD1-VEGF in Nasopharyngeal Carcinoma
ConditionRecurrent/ Metastatic NPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
This study is to determine the activity and tolerability of JS207 as a single agent and in combination cohort with chemotherapy. This is an open-labelled, phase Ib/II study of JS207 in patients with previously treated recurrent or metastatic nasopharyngeal carcinoma. The study will comprise of two phases:
* Phase 1b monotherapy: Consisting of a dose escalation and then expansion phase in patients with recurrent/ metastatic (R/M) NPC, who have failed at least 1 prior line of platinum-based chemotherapy, with or without prior treatment with PD1/ PDL1 inhibitor. * Randomized phase II: Combination of JS207 with capecitabine or paclitaxel in platinum-refractory patients: Patients who have failed one prior line of platinum-based chemotherapy for R/M NPC will be treated with JS207 in combination with capecitabine.
As phase I portion of the study was completed, the starting dose of JS207 for phase II portion will be 10mg/kg IV every 3 weeks.
Eligibility criteria
Qualifiers
Known histologically confirmed diagnosis of nasopharyngeal carcinoma
Measurable disease according to RECIST ver 1.1.
Age 18 or above and younger than 80 years old; ECOG performance 0 or 1.
Absolute neutrophil count ≥ 1.5 × 10^9 /L; Platelets ≥ 90×10^9 /L; Hemoglobin > 9 g/dL.
Disqualifiers
Prior radical RT to the primary NPC within 12 months
Known history of nasopharyngeal necrosis
Presence of locoregional tumor recurrence or distant metastatic disease associated with invasion of major vascular structure(s) on imaging which may increase the risk of serious bleeding. This may include (but not limited to) regional neck recurrence invading major vascular structures or ;
Presence of central lung lesions involving major blood vessels;
Trial design
Treatments tested in this trial
- JS207
- Paclitaxel
- Capecitabine
Treatment groups
49 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov