A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma

Part of paid clinical trials in New York, New York.

Sponsor
QBiotics Group Limited
Study ID
NCT05755113
Phase
PHASE2
Status
Recruiting

Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tigilanol Tiglate — DRUG
    Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.

Study Details

A Phase IIa open label study evaluating the preliminary efficacy of intratumoural tigilanol tiglate in advanced and/or metastatic soft tissue sarcoma of the extremities and body wall.

Key Dates

Start date
Apr 13, 2023
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm, Open Label
    Single or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area \[BSA\]) per treatment.

Primary Outcome Measure

Tumour Response [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CentreNew YorkNew York10065
Edmund Bartlett (PRINCIPAL_INVESTIGATOR)

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