Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • JS207

    Drug

    10mg/kg IV every 3 weeks

  • Paclitaxel

    Drug

    135 mg/m² b.d. IV at 3-weekly cycle until disease progression or intolerance

  • Capecitabine

    Drug

    1000 mg/m² b.d. orally from days 1 to 14 at 3-weekly cycle until disease progression or intolerance

Treatment groups

49 Participants
are divided into 2 treatment groups
Group A: JS207 + capecitabine combination therapyExperimental treatment 2 interventions
Group B: JS207 + paclitaxel combination therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

The proportion of patients with complete response (CR) or partial response (PR) according to RECIST v1.1.

Time frame
2 years

Secondary outcomes

1

Progression-free survival (PFS)

The time from treatment initiation to disease progression or death from any cause

Time frame
2 years
2

Overall survival (OS)

The survival time until death from any cause

Time frame
2 years
3

Duration of response (DoR)

The time from the first evidence of response to disease progression or death

Time frame
2 years
4

Site of tumour progression at disease progression

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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