Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT04843098 | Active Not Recruiting Phase 1

• 1 other identifier: TL-117-202001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, pharmacokinetic and efficacy of TL117 plus paclitaxel in patients with recurrent or metastatic head and neck cancer.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment

  Per DLT criteria as defined in protocol

  From time of the first dosing to time of Cycle 1 Day 28（each cycle is 28 days）

• Phase Ib -Dose Limiting Toxicity (DLT) of TL117 plus paclitaxel combination treatment

  Per DLT criteria as defined in protocol

  From time of the first dosing to time of Cycle 1 Day 28（each cycle is 28 days）

• Phase II - Objective response rate (ORR)

  Objective response rate (ORR): percentage of patients with best overall response of complete response (CR) and partial response (PR) according to RECIST v1.1.

  Every 8 weeks from date of first treatment until date of last treatment up to 12 months

Study Arms (1)

Single arm, open label

EXPERIMENTAL

Phase 1a: All subjects receiving TL117 alone (20-120 mg); Phase 1b: All subjects receiving TL117 (MTD-1 or MTD) plus Paclitaxel; Phase 2: All subjects receiving TL117 in combination with Paclitaxel at RP2D

Drug: TL117; Drug: Paclitaxel

Interventions

TL117 DRUG

TL117 capsules orally once daily

Single arm, open label

Paclitaxel DRUG

Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 28-day treatment cycle.

Single arm, open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old for Phase 1a, 18-75 years old for Phase 1b and 2;
• Histologically and/or cytologically confirmation of recurrent/metastatic squamous cell carcinoma of the head and neck;
• At least one evaluable or measurable tumor lesion;
• Adequate performance status;
• A minimum life expectancy of \> 3 months;
• Adequate cardiac, kidney, and liver function;
• Willingness of all subjects of childbearing potential to use acceptable methods of birth control;

You may not qualify if:

• Any chemotherapy, radiotherapy, targeted therapy, immunotherapy, endocrine therapy and other systematic anti-tumor therapies within 4 weeks prior to the first dose of the study drug (some exceptions apply)
• Prior or current PI3K inhibitor therapy;
• Type 1 or type 2 diabetes requiring antihyperglycemic medication;
• Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose, or required elective surgery during the study period;
• Any unresolved toxicities from prior therapy greater than Grade 1;
• Inability to swallow, or serious gastrointestinal absorption conditions;
• History of immunodeficiency;
• Active central nervous system metastases;
• Active hepatitis B or C virus infection;
• Uncontrolled active infection;
• Serious cardiovascular disease；
• Clinically uncontrollable effusion in the third space;
• Known allergy and/or contraindications to paclitaxel;
• Known alcohol or drug dependence;
• Mental disorders or poor compliance;

Sponsors & Collaborators

• Suzhou Junde Biotechnology Co., Ltd: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 13, 2021
• Study Start: May 26, 2021
• Primary Completion: November 20, 2024
• Study Completion: June 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)