Solid Tumors With FGFR2 Alterations, AdultPhase 1NCT06800196
A Study of KNT-0916 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
A Phase 1 study testing KNT-0916 in people with Solid Tumors With FGFR2 Alterations, Adult, run by KinoTeck Therapeutics Co., Ltd at 1 site in China.
Trial summary
This is a Phase1, open-label, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of KNT-0916 in patients with unresectable or metastatic solid tumors harboring FGFR2 alterations who have failed prior systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors With FGFR2 Alterations, Adult
- What is being tested?
- KNT-0916
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 31 Dec 2027
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed unresectable or metastatic solid tumor
- Documented FGFR2 gene fusion, mutation, or amplification per testing of blood and/or tumor
- Patient must have measurable disease per RECIST v1.1
- Patient has ECOG performance status of 0-1
- Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy
- An expected survival of ≥ 12 weeks.
- Adequate organ function, as measured by laboratory values
Who cannot join
- Prior treatment with any FGFR2 target therapy.
- Central nervous system metastasis with associated symptom and signs.
- Clinically significant, uncontrolled cardiovascular disease.
- History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy 5. As judged by the investigator, unsuitable for attending the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Ruihua professor
About this study
Official title: A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics, Preliminary Efficacy of KNT-0916 in Subjects With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
This is a Phase1, open-label, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of KNT-0916 in patients with unresectable or metastatic solid tumors harboring FGFR2 alterations who have failed prior systemic therapy. This study is divided into 2 parts, dose escalation part(part A), dose expansion part(partB).
Read the detailed description
This study is divided into 2 parts, part a isNdesigned to explore the maximum toxicity dose (MTD) of KNT-0916 with an accelerated titration plus traditional "3+3" design; part b is designed to explore the elementary anti-neoplastic activity of KNT-0916 with recommended dose in patients with confirmed FGFR2 alterations through central laboratory testing.
- Being tested
- KNT-0916
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KNT-0916Drug
- KNT-0916 is an oral inhibitor of FGFR2.
| Study group | Role | What they receive |
|---|---|---|
| Part A - dose escalation | Experimental | Dose escalation of KNT-0916 in patients with advanced solid tumors. Receives: Drug: KNT-0916 |
| Part B - expansion | Experimental | Oral dose of KNT-0916 as determined during Part A Dose Escalation. Receives: Drug: KNT-0916 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity (DLT)
Measured: 4 weeks
Maximum tolerated dose (MTD) or Maximum administered dose (MAD)
Measured: 12 months
Incidence, relatedness, seriousness and severity of adverse events (AEs) per the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) Version 5.0.
Measured: 33 months
Recommended phase 2 dose (RP2D)
Measured: 33 months
Secondary outcomes (10)
Objective response rate (ORR) assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: 33 months
Duration of response (DoR) assessed as per RECIST 1.1
Measured: 33 months
Disease control rate (DCR) assessed as per RECIST 1.1
Measured: 33 months
Progression-free survival (PFS) assessed as per RECIST 1.1
Measured: 33 months
Overall survival (OS) assessed as per RECIST 1.1
Measured: 33 months
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)
Measured: 33 months
Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)
Measured: 33 months
Pharmacokinetic parameters including half-life (t1/2)
Measured: 33 months
Pharmacokinetic parameters including time to maximum concentration (Tmax)
Measured: 33 months
Pharmacokinetic parameters including Apparent clearance (CL/F)
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start10 Apr 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors With FGFR2 Alterations, AdultStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KinoTeck Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800196
- Sponsor's protocol ID
- EO002-CP002
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics, Preliminary Efficacy of KNT-0916 in Subjects With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
- ClinicalTrials.gov ID
- NCT06800196
- Acronym / sponsor ID
- EO002-CP002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- KinoTeck Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jan 2025 (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.
This is a Phase1, open-label, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of KNT-0916 in patients with unresectable or metastatic solid tumors harboring FGFR2 alterations who have failed prior systemic therapy. This study is divided into 2 parts, dose escalation part(part A), dose expansion part(partB).
Detailed description
This study is divided into 2 parts, part a isNdesigned to explore the maximum toxicity dose (MTD) of KNT-0916 with an accelerated titration plus traditional "3+3" design; part b is designed to explore the elementary anti-neoplastic activity of KNT-0916 with recommended dose in patients with confirmed FGFR2 alterations through central laboratory testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A - dose escalation | Experimental | Drug: KNT-0916Dose escalation of KNT-0916 in patients with advanced solid tumors. |
| Part B - expansion | Experimental | Drug: KNT-0916Oral dose of KNT-0916 as determined during Part A Dose Escalation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed unresectable or metastatic solid tumor
- Documented FGFR2 gene fusion, mutation, or amplification per testing of blood and/or tumor
- Patient must have measurable disease per RECIST v1.1
- Patient has ECOG performance status of 0-1
- Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy
Key exclusion criteria (4 listed)
- Prior treatment with any FGFR2 target therapy.
- Central nervous system metastasis with associated symptom and signs.
- Clinically significant, uncontrolled cardiovascular disease.
- History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy 5. As judged by the investigator, unsuitable for attending the study.
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 |
|---|---|---|
| KNT-0916• KNT-0916 is an oral inhibitor of FGFR2. | Drug | Part A - dose escalation, Part B - expansion |
Primary outcome
Dose-limiting Toxicity (DLT)
Time frame: 4 weeks
Maximum tolerated dose (MTD) or Maximum administered dose (MAD)
Time frame: 12 months
Incidence, relatedness, seriousness and severity of adverse events (AEs) per the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) Version 5.0.
Time frame: 33 months
Recommended phase 2 dose (RP2D)
Time frame: 33 months
10 secondary outcomes
Objective response rate (ORR) assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 33 months
Duration of response (DoR) assessed as per RECIST 1.1
Time frame: 33 months
Disease control rate (DCR) assessed as per RECIST 1.1
Time frame: 33 months
Progression-free survival (PFS) assessed as per RECIST 1.1
Time frame: 33 months
Overall survival (OS) assessed as per RECIST 1.1
Time frame: 33 months
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)
Time frame: 33 months
Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)
Time frame: 33 months
Pharmacokinetic parameters including half-life (t1/2)
Time frame: 33 months
Pharmacokinetic parameters including time to maximum concentration (Tmax)
Time frame: 33 months
Pharmacokinetic parameters including Apparent clearance (CL/F)
Time frame: 33 months
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 5 Aug 2026.
- 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.
Ruihua Xu principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KNT-0916 in people with Solid Tumors With FGFR2 Alterations, Adult, run by KinoTeck Therapeutics 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 4 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. 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 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.
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?
Contact Lei Li (0086 13711344347, lilei@kino-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (DLT) (time frame: 4 weeks). The study lists 4 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 5 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.