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

Sponsor
Suzhou Junde Biotechnology Co., Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04843098
Collaborator
(none)
108
1
33

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

This is a Phase 1/2 open label, single arm study, and is divided into three phases: the single-agent dose-escalation phase Ia trial, the TL117 plus paclitaxel dose-escalation phase Ib trial, and the open label, multicenter phase 2 trial of TL117 plus paclitaxel.

Adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 28. When the maximum tolerated dose (MTD) of TL117 plus paclitaxel is determined, additional patients will be treated at the defined RP2D dose until occurrence of unacceptable toxicity, disease progression or withdrawal of consent or death.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of the PI3K Inhibitor TL117 Alone and in Combination With Paclitaxel in Patients With Relapsed/Metastatic Squamous Cell Carcinoma of the Head and Neck
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm, open label

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
TL117 capsules orally once daily

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

Outcome Measures

Primary Outcome Measures

  1. Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment [From time of the first dosing to time of Cycle 1 Day 28(each cycle is 28 days)]

    Per DLT criteria as defined in protocol

  2. Phase Ib -Dose Limiting Toxicity (DLT) of TL117 plus paclitaxel combination treatment [From time of the first dosing to time of Cycle 1 Day 28(each cycle is 28 days)]

    Per DLT criteria as defined in protocol

  3. Phase II - Objective response rate (ORR) [Every 8 weeks from date of first treatment until date of last treatment up to 12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 18-70 years old for Phase 1a, 18-75 years old for Phase 1b and 2;

  2. Histologically and/or cytologically confirmation of recurrent/metastatic squamous cell carcinoma of the head and neck;

  3. At least one evaluable or measurable tumor lesion;

  4. Adequate performance status;

  5. A minimum life expectancy of > 3 months;

  6. Adequate cardiac, kidney, and liver function;

  7. Willingness of all subjects of childbearing potential to use acceptable methods of birth control;

Exclusion Criteria:
  1. 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)

  2. Prior or current PI3K inhibitor therapy;

  3. Type 1 or type 2 diabetes requiring antihyperglycemic medication;

  4. 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;

  5. Any unresolved toxicities from prior therapy greater than Grade 1;

  6. Inability to swallow, or serious gastrointestinal absorption conditions;

  7. History of immunodeficiency;

  8. Active central nervous system metastases;

  9. Active hepatitis B or C virus infection;

  10. Uncontrolled active infection;

  11. Serious cardiovascular disease;

  12. Clinically uncontrollable effusion in the third space;

  13. Known allergy and/or contraindications to paclitaxel;

  14. Known alcohol or drug dependence;

  15. Mental disorders or poor compliance;

  16. Pregnant or lactating women;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Suzhou Junde Biotechnology Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Junde Biotechnology Co., Ltd
ClinicalTrials.gov Identifier:
NCT04843098
Other Study ID Numbers:
  • TL-117-202001
First Posted:
Apr 13, 2021
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2021