A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma

NCT04653038 | Terminated Phase 1 FDA Drug

• 1 other identifier: ZL-1301-003
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 13

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.

Conditions

Unresectable, Recurrent or Metastatic Melanoma; Untreated Mucosal or Acral Lentiginous Melanoma

Keywords

Melanoma; MGD013

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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

  Approximately 12 months after dosed

Secondary Outcomes (13)

• Objective Response Rate (ORR)

  Approximately 12 months after dosed

• Objective Response Rate (ORR)

  Approximately 12 months after dosed

• Overall Survival (OS)

  Approximately 24 months

• Progression-free Survival (PFS)

  Approximately 12 months after dosed

• Disease Control Rate (DCR)

  Approximately 12 months after dosed

Study Arms (2)

Unresectable, recurrent or metastatic melanoma

EXPERIMENTAL

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

Drug: MGD013

Untreated mucosal or acral lentiginous melanoma

EXPERIMENTAL

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

Drug: MGD013

Interventions

MGD013 DRUG

A fixed dose of MGD013 600mg IV Q2W will be administered to subjects

Unresectable, recurrent or metastatic melanoma; Untreated mucosal or acral lentiginous melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• ≥ Grade 3 ocular adverse events
• Grade 4 liver function abnormalities
• Grade ≥ 3 neurologic adverse reactions
• ≥ Grade 3 colitis
• ≥ Grade 3 renal adverse reactions

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead

Study Sites (13)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, China

Location

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Location

Jilin Cancer Hospital

Changchun, Jilin, China

Location

The first hospital of Jilin University

Changchun, Jilin, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Tangdu Hospital

Xi’an, Shanxi, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Location

Sir Run Shaw Hospital, School Of Medicine ,Zhejiang University

Hangzhou, Zhejiang, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Recurrence; Melanoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jun GUO

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 4, 2020
• Study Start: October 29, 2020
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

CN (13)