Intratumoral Tigilanol Tiglate for Soft Tissue Sarcoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: QBiotics Group Limited
Must not be taking: Warfarin
Disqualifiers: Brain metastases, Major surgery, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires a 28-day period without taking any systemic anticancer therapy or investigational agents before starting the study treatment. This means you may need to stop certain medications, but it's best to discuss your specific situation with the study team.
What makes the drug Tigilanol Tiglate unique for treating soft tissue sarcoma?
Research Team
EB
Edmund Bartlett, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Adults with advanced soft tissue sarcoma in limbs or body wall, able to consent and follow study rules. They must have a life expectancy over 12 weeks, be relatively active (ECOG ≤ 2), and not pregnant or breastfeeding. Participants need functioning kidneys and liver, agree to use contraception, and can't have major blood vessel tumors or recent treatments that conflict with the trial.Inclusion Criteria
I can take care of myself and am up and about more than half of my waking hours.
Willing and able to provide written informed consent for the study prior to any protocol-specific procedures and to comply with all local and study requirements
I am 18 years old or older.
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Exclusion Criteria
I plan to have direct tumor treatment or radiation within 28 days before screening or while on tigilanol tiglate.
My tumor is near or has spread into a major blood vessel.
I haven't had major surgery in the last 28 days and don't expect to need any during the study.
See 6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive single or multiple intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2
6 months
Multiple visits for injections and assessments
Follow-up
Participants are monitored for safety, efficacy, and local recurrence rate after treatment
6 months
Regular follow-up visits for monitoring
Pharmacokinetic Assessment
Evaluation of systemic exposure and metabolite analysis after a single intratumoural injection
24 hours
1 visit for blood sampling
Treatment Details
Interventions
- Tigilanol Tiglate (Virus Therapy)
Trial OverviewThe trial is testing Tigilanol Tiglate's effectiveness when injected directly into tumors of patients with advanced soft tissue sarcomas. It's an open-label Phase IIa study meaning everyone gets the treatment and both doctors and participants know what's being given.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single Arm, Open LabelExperimental Treatment1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Cancer CentreNew York, NY
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Who Is Running the Clinical Trial?
QBiotics Group Limited
Lead Sponsor
Trials
4
Patients Recruited
80+
Findings from Research
In a study of 11 patients with sarcoma, nanosomal docetaxel lipid suspension (NDLS) chemotherapy showed promising efficacy, with a 50% overall response rate and a 66.7% disease control rate in metastatic cases, indicating its potential effectiveness in treating this type of cancer.
NDLS-based chemotherapy was well tolerated, with no new safety concerns identified, although 63.6% of patients experienced at least one adverse event, primarily hematological and gastrointestinal issues.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Sarcoma: A Multicenter, Retrospective Study.Narayanan, P., Dattatreya, PS., Prasanna, R., et al.[2022]
In a study involving 36 patients with advanced soft tissue sarcoma, edatrexate showed a partial response rate of 14%, with notable effectiveness in patients with malignant fibrous histiocytoma (MFH), where 5 out of 7 patients experienced a partial response.
While the overall activity of edatrexate was limited, it was generally well-tolerated, with mild myelosuppression and manageable side effects like fatigue and rash, suggesting that further research is needed, particularly for MFH patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Edatrexate in patients with soft tissue sarcoma. Activity in malignant fibrous histiocytoma.Casper, ES., Christman, KL., Schwartz, GK., et al.[2019]
Ecteinascidin (ET-743) demonstrated promising antitumor activity in patients with advanced soft tissue sarcoma, achieving an 8% partial response rate and a 56% progression arrest rate in specific sarcoma types, indicating its potential effectiveness as a second- or third-line treatment.
The treatment was associated with manageable safety concerns, primarily reversible liver enzyme elevations and neutropenia, with no cumulative toxicities observed, and a median overall survival of 9.2 months in heavily pretreated patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial.Le Cesne, A., Blay, JY., Judson, I., et al.[2018]
References
Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients. [2018]
Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Sarcoma: A Multicenter, Retrospective Study. [2022]
Suppression of soft tissue sarcoma growth by a host defense-like lytic peptide. [2021]
Edatrexate in patients with soft tissue sarcoma. Activity in malignant fibrous histiocytoma. [2019]
Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial. [2018]