Health TrialsbyHealthPanel

A Clinical Study of T3011 in Subjects With Advanced Melanoma

ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pharmaceuticals Holding Co., Ltd

About this trial

This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with advanced melanoma;

At least one measurable lesion;

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;

Expected survival > 12 weeks;

Disqualifiers

Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;

Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.

At screening, subjects with a history or evidence of high risk cardiovascular disease;

Subjects with persistent or active infection requiring intravenous anti-infective therapy;

Trial design

Design model

Single group

Treatments tested in this trial

  • T3011

    Biological/Vaccine

    T3011 will be given intratumorally， Q2W；

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: T3011Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events

Adverse event type, incidence, duration

Time frame
Approximately 2 years
2

Objective response rate(ORR)

Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1

Time frame
Approximately 2 years

Secondary outcomes

1

Disease control rate (DCR)

DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease

Time frame
Approximately 2 years
2

Duration of remission (DOR)

DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.

Time frame
Approximately 2 years
3

Progression-free survival (PFS)

From the start date of study treatment to the date of progression disease or death , whichever occurred first.

Time frame
Approximately 2 years
4

Overall Survival (OS)

Determination of the overall survival time of all patients

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

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

Shanghai Pharmaceuticals Holding Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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