Head and Neck Squamous Cell CarcinomaPhase 1/2NCT04843098
Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 1/2 study testing TL117 and Paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Suzhou Junde Biotechnology Co., Ltd at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- TL117 and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2021to Jun 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 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;
Who cannot join
- 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;
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- 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;
- Pregnant or lactating women;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- TL117, Paclitaxel
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL117Drug
TL117 capsules orally once daily
PaclitaxelDrug
Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 28-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: TL117; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment
Per DLT criteria as defined in protocol
Measured: 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
Measured: 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.
Measured: Every 8 weeks from date of first treatment until date of last treatment up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start26 May 2021
- Primary completion20 Nov 2024
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Junde Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843098
- Sponsor's protocol ID
- TL-117-202001
- Status last verified
- Dec 2024
- First submitted
- 19 Mar 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04843098
- Acronym / sponsor ID
- TL-117-202001
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Suzhou Junde Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, open label | Experimental | Drug: TL117, Drug: PaclitaxelPhase 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-70 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TL117TL117 capsules orally once daily | Drug | Single arm, open label |
| PaclitaxelPaclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 28-day treatment cycle. | Drug | Single arm, open label |
Primary outcome
Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment
Time frame: 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
Phase Ib -Dose Limiting Toxicity (DLT) of TL117 plus paclitaxel combination treatment
Time frame: 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
Phase II - Objective response rate (ORR)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TL117 and Paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Suzhou Junde Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment (time frame: From time of the first dosing to time of Cycle 1 Day 28（each cycle is 28 days）). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.