An Open-label, Multi-cohort, Multi-center Phase I Study Evaluating the Efficacy and Safety of MGD013 in Patients With Unresectable, Recurrent or Metastatic Malignant Melanoma

Zai Lab (Shanghai) Co., Ltd.13 sites in 1 country92 target enrollmentOctober 29, 2020

ConditionsUnresectable, Recurrent or Metastatic Melanoma Untreated Mucosal or Acral Lentiginous Melanoma

InterventionsMGD013

Overview

Phase: Phase 1
Intervention: MGD013
Conditions: Unresectable, Recurrent or Metastatic Melanoma
Sponsor: Zai Lab (Shanghai) Co., Ltd.
Enrollment: 92
Locations: 13
Primary Endpoint: Objective Response Rate (ORR)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, multi-cohort, multi-center Phase I clinical trial to evaluate the efficacy and safety of MGD013 in ① Cohort 1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy; ② Cohort 2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma.

Detailed Description

The study is conducted in two parts for both Cohort 1 and Cohort 2. Part I: Safety evaluation and efficacy exploration for MGD013. Part II: Efficacy expansion based on results from Part I to further evaluate the efficacy effect of MGD013.

Registry

clinicaltrials.gov

Start Date

October 29, 2020

End Date

March 2, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zai Lab (Shanghai) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary and able to provide signed informed consent form
•Male or female aged ≥ 18 years
•Patient can comply with protocol requirements as assessed by the investigator
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0, or 1
•Histologically confirmed unresectable recurrent or metastatic melanoma:
•Cohort 1: The pathological type is cutaneous or acral lentiginous, or unknown origin. Progressive or recurrent disease on at least one prior line of systemic therapies. In addition, prior systemic therapies must include one line of anti-PD-(L)1 and/or anti-CTLA-4 immune checkpoint inhibitors. Patients with BRAF-mutated or KIT-mutated/amplified melanoma, and prior treatment with vemurafenib or imatinib is not mandatory;
•Cohort 2: Histologically confirmed pathological type is acral lentiginous or mucosal. No prior systemic therapy for recurrent or metastatic disease.
•Patients with at least one measurable lesion according to irRECIST; assessed by investigator per irRECIST criteria to establish a baseline tumor assessment, and should be performed within 28 days prior to the first dose.

Exclusion Criteria

•The pathological type of patient is:
•Cohort 1: Mucosal melanoma; uveal melanoma;
•Cohort 2: Cutaneous melanoma; uveal melanoma; melanoma of unknown origin; known BRAF mutation or KIT mutation/amplification.
•Central nervous system metastases with clinical symptoms. Patients with prior central nervous system metastases who have received local therapy, have stable disease for ≥ 4 weeks, and meet the following criteria can be enrolled:
•No treatment for central nervous system metastases during the screening period (e.g., surgery, radiotherapy, mannitol, corticosteroid therapy-prednisolone \> 10 mg per day or equivalent dose)
•No progression of central nervous system lesions on MRI or CT within 14 days prior to start of study treatment
•No meningeal metastasis or notochord compression
•Subjects with a history of symptomatic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function or may interfere with the detection and treatment of suspected drug-related pulmonary adverse reactions;
•Prior treatment with any antibody/drug targeting the regulation of T cell function (immune checkpoint) (e.g., anti-LAG-3, anti-0X-40, anti-CD137, anti-TIM-3, anti-TIGIT, IDO)
•Patients who have previously received immune checkpoint inhibitors (e.g., anti-PD-(L)1, anti-CTLA-4 antibody) are not included if they experience any of the following immune checkpoint-related adverse events, regardless of recovery:

Arms & Interventions

Unresectable, recurrent or metastatic melanoma

Cohort1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy

Intervention: MGD013

Untreated mucosal or acral lentiginous melanoma

Cohort2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma

Intervention: MGD013

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Time Frame: Approximately 12 months after dosed

Objective Response Rate (ORR) is defined as the proportion of patients with a best response of CR or PR in enrolled patients, which is assessed by Independent Review Committee (IRC) per RECIST v1.1