A Clinical Study of T3011 in Patients With Advanced Cutaneous or Subcutaneous Malignancies
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|ClinicalTrials.gov Identifier: NCT04370587|
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : September 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Soft Tissue Tumor and/or Sarcoma Neoplasm of Skin Neoplasm Metastasis Melanoma Lung Cancer Solid Tumor||Biological: T3011||Phase 1|
This is a phase 1, open-label, first-in-human study of T3011 monotherapy. The study will be conducted in 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion. The objectives of this study are to evaluate the safety and tolerability of escalating doses of T3011, and to determine the Maximum Tolerated Dose (MTD) or the recommended dose(s) of T3011 by Safety Review Committee (SRC) to be further examined during Part 2. In both parts, the safety, tolerability, pharmacokinetics (PK), viral shedding, immunogenicity, and clinical activity of T3011 will be evaluated. Pharmacodynamics (PD) markers related to T3011 exposure will be characterized.
Part 1 will include up to 4 dose levels (from 1E+6 PFU/mL (plaque-forming unit/milliliter) to 1E+8 PFU/mL) of 3-6 patients at each dose, enrolling a maximum of 24 patients. Approximately 30 patients will be enrolled into Part 2 Dose Expansion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of T3011 in Advanced Cutaneous or Subcutaneous Malignancies|
|Actual Study Start Date :||May 30, 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: Escalating doses of T3011 Injection
Dose escalation study of T3011 with 4 cohorts from 1E+6 pfu/mL to 1E+8 pfu/mL
Intratumoral injection of maximum 4mL at each dose level
Experimental: Dose expansion of T3011 with recommended dose
Does expansion with MTD or SRC recommended dose from Arm 1
Intratumoral injection at dose of MTD established in Arm 1 or recommended by SRC.
- Safety and tolerability of T3011 in dose escalating administration in patients with advanced cutaneous or subcutaneous malignancies [ Time Frame: From first dose of T3011 (Week 1 Day 1) until 60 days after the last T3011 injection (up to 2 years) ]Number of participants in dose escalating arm with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
- Safety and tolerability of T3011 in dose expansion administration in patients with advanced cutaneous or subcutaneous malignancies [ Time Frame: From first dose of T3011 (Week 1 Day 1) until 60 days after the last T3011 injection (up to 2 years) ]Number of participants in dose expansion arm with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
- Presence and frequency of T3011 in serum, saliva, urine, and injection site/dressing [ Time Frame: Up to 24 months ]To evaluate the virus shedding following intratumoral injection
- Quantitative measurements of serum IL-12 and anti-PD-1 antibody concentration. [ Time Frame: Up to 24 months ]To evaluate IL-12 and anti-PD-1 antibody expression of T3011 post intervention.
- Presence of neutralizing antibodies of anti-PD-1 antibody for antidrug antibodies (ADAs) development [ Time Frame: Up to 24 months ]To evaluate the immunogenicity of anti-PD-1 antibody expressed by T3011 post intervention.
- Presence of anti-herpes simplex virus type 1 (HSV-1) antibody compared to baseline [ Time Frame: Up to 24 months ]To evaluate the immunogenicity of T3011 viral vector post intervention.
- Overall response rate (ORR) [ Time Frame: Up to 24 months ]ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Disease control rate (DCR) [ Time Frame: Up to 24 months ]DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments per RECIST 1.1.
- Duration of response (DOR). [ Time Frame: Up to 24 months ]DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
- Durable response (DR) [ Time Frame: Up to 24 months ]DR is defined as objective response (CR or PR) according to RECIST 1.1, with a duration of at least 6 months.
- Survival (assessment per RECIST 1.1 and immune-modified RECIST (imRECIST)). [ Time Frame: Up to 24 months ]To evaluate the progression free survival (PFS) and overall survival (OS) of participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370587
|United States, Arizona|
|Banner MD Anderson Cancer Center||Recruiting|
|Gilbert, Arizona, United States, 85234|
|Contact: Brenda Noggy Brenda.Noggy@bannerhealth.com|
|Principal Investigator: Jason Niu, MD,PhD|
|United States, Texas|
|Mary Crowley Cancer Research||Recruiting|
|Dallas, Texas, United States, 75230|
|Contact: Dr. Barve, MD firstname.lastname@example.org|
|Principal Investigator: Minal Barve, MD|
|Bedford Park, Australia|
|Contact: Dr.Kichenadasse email@example.com|
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|Peninsula & South Eastern Haematology and Oncology Group||Recruiting|
|Contact: Dr. Ganju firstname.lastname@example.org|
|Principal Investigator: Vinod Ganju, A/Prof|
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