CTRI/2019/11/022032
Other
Phase 1
Exploratory Phase Ib/IIa Study of Intratumourally Administered Tigilanol Tiglate to Assess Safety, Tolerability and Tumour Response in Patients with Head and Neck Squamous Cell Carcinoma.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Sponsor
- QBiotics Group Limited
- Enrollment
- 13
- Status
- Other
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. An adult (\>\= 18 years old);
- •2\. Willing and able to provide written informed consent prior to any protocol\-required procedures and comply with all local and study requirements;
- •3\. Resectable or unresectable, histologically or cytologically confirmed HNSCC, accessible and amenable for IT (intratumoural) injection, that meets at least one of the following:
- •refractory to at least one round of conventional therapy; or
- •no available standard therapy; or
- •patient declined standard therapy after appropriate counselling (with the decision documented); or
- •patient awaiting surgery or therapy or is explicitly being monitored with the aim of delaying therapy.
- •4\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- •5\. Life expectancy more than 12 weeks;
- •6\. Disease that is measurable (i.e., each target tumour \>\= 2 mm in diameter that can be accurately measured in at least two dimensions) by calliper. Up to 4 measurable target tumours with a maximum combined volume of 150 cm3 and up to 5 non\-target tumours to be selected at the discretion of the PI;
Exclusion Criteria
- •1\. Target tumours intended for treatment immediately adjacent to, or with infiltration into, major arteries or veins;
- •2\. Target tumours intended for treatment located in an area where post\-injection swelling could compromise the airway;
- •3\. Target tumours intended for treatment requiring urgent resection;
- •4\. Participated in any investigational intervention study within 30 days prior to study treatment;
- •5\. Treatment with any anti\-cancer treatment (e.g., immunotherapy \[e.g., anti\-PD\-1/L1 inhibitor], biological therapy, chemotherapy, anti\-cancer vaccine therapy, oncolytic viral or microbial
- •therapy \[e.g., T\-VEC/ ImlygicTM, toll\-like receptor \[TLR] agonists, STING or RIG\-1], etc.) other
- •than prior tigilanol tiglate injection as part of this study, within 4 weeks prior to study
- •6\. Any oncology related surgery within 4 weeks prior to study treatment;
- •7\. Any previous surgery in the area of the intended target tumour in proximity of the airway
- •(such that tracking of the injected fluid may be unpredictable and could lead to airway swelling);
Outcomes
Primary Outcomes
Not specified
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