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Active, not recruitingNCT04843098Updated Dec 9, 2024

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

A Phase 1/2 interventional study of TL117 and Paclitaxel in Head and Neck Squamous Cell Carcinoma, sponsored by Suzhou Junde Biotechnology Co., Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by Suzhou Junde Biotechnology Co., Ltd · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
108
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Head and Neck Squamous Cell Carcinoma
03

In context

Squamous Cell Carcinoma of Head and Neck

1,711 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 544 are open to participants now.

This study's planned enrollment of 108 is above the median of 50 across 1,456 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

This is the only study on the registry with Suzhou Junde Biotechnology Co., Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
108 participants (estimated)

Study arms

  • 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 · Drug: Paclitaxel

Interventions

  • DrugTL117

    TL117 capsules orally once daily

  • DrugPaclitaxel

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

06

What researchers measure

Primary outcomes

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

    Per DLT criteria as defined in protocol

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

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

    Per DLT criteria as defined in protocol

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

  3. 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.

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

07

Study locations

1 site
  • Shanghai East Hospital
    Shanghai, Shanghai Municipality 200120, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2021 to primary completion in Nov 2024, 41 months.

Of 82 industry-sponsored phase 1/2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 87. This study's 41 months is below that.

Counting every sponsor, half of 125 studies reached it within 63 months; a quarter within 47 and three quarters within 84.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2021
First posted
Apr 13, 2021
StartActual
May 26, 2021
Primary completionActual
Nov 20, 2024
CompletionEst.
Jun 2025
Last update
Dec 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04843098
Lead sponsor
Suzhou Junde Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Apr 13, 2021
Start date
May 26, 2021
Primary completion
Nov 20, 2024
Completion
Jun 2025 (estimated)
Last update
Dec 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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