Solid Tumor (Phase I)Phase 1NCT07894874
A Study to Evaluate YF550 in Participants With Locally Advanced or Metastatic Solid Tumors.
A Phase 1 study testing YF550 in people with Solid Tumor (Phase I) and Ovarian Cancer, run by InventisBio Yiqi Beijing Limited.
Trial summary
This study is a open-label, multicenter clinical trials. The target population is participants with locally advanced or metastatic solid tumors. A total of 204 participants are planned to be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor (Phase I), Ovarian Cancer, NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- YF550
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years, male or female, with signed informed consent.
- Histologically or cytologically confirmed locally advanced, unresectable, and/or metastatic solid tumors.
- At least one measurable lesion per RECIST 1.1.
- Availability of an adequate and qualified tumor tissue sample.
- ECOG performance status score of ≤ 1.
- Life expectancy of ≥ 12 weeks.
- Male participants and female participants of childbearing potential must agree to abstinence or use effective contraception from the time of signing the informed consent form (ICF) until 6 months after the last dose of study drug.
- Adequate organ function, as defined in the protocol.
Who cannot join
- Prior or current treatment with the same class of drugs or related therapies as specified in the protocol.
- Unstable or progressive central nervous system (CNS) metastases, carcinomatous meningitis, brainstem metastases, and/or spinal cord compression.
- Clinically significant cardiovascular or cerebrovascular disease.
- History of interstitial lung disease (ILD), radiation pneumonitis, immune-related pneumonitis, or non-infectious pneumonitis requiring corticosteroid treatment; active non-infectious pneumonitis or interstitial lung changes, including ILD, radiation pneumonitis, or immune-related pneumonitis, at screening; or hospitalization or treatment with intravenous medications for any active infection within 4 weeks before the first dose of study drug.
- Gastrointestinal (GI) dysfunction or GI disease that may significantly affect the absorption or metabolism of orally administered study drug.
- Toxicities resulting from prior anticancer therapy that have not recovered to the level specified in the protocol.
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- Major surgery within 4 weeks before administration of the study intervention, or the last dose of palliative radiotherapy within 2 weeks before administration of the study intervention.
- Positive human immunodeficiency virus (HIV) antibody test; positive hepatitis B surface antigen (HBsAg) with hepatitis B virus deoxyribonucleic acid (HBV DNA) levels exceeding 2,500 copies/mL or 500 IU/mL; or positive hepatitis C virus (HCV) antibody test with hepatitis C virus ribonucleic acid (HCV RNA) levels exceeding the upper limit of normal at the study site.
- Participants who are pregnant or breastfeeding, or who currently intend or plan to become pregnant or father a child.
- Other malignancies diagnosed within 5 years before enrollment.
- Severe neuropsychiatric or psychological disorders, a history of substance abuse, or a history of severe alcohol abuse.
- Any other significant clinical abnormality or medical condition that, in the investigator's judgment, may pose a safety risk to the participant or interfere with study treatment or clinical assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YF550 in Participants With Locally Advanced or Metastatic Solid Tumors.
This study is a open-label, multicenter clinical trials. The target population is participants with locally advanced or metastatic solid tumors. A total of 204 participants are planned to be included.
Read the detailed description
This study consists of two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion), with each treatment cycle lasting 21 days. Up to 84 participants will be enrolled in Phase Ia and up to 120 participants in Phase Ib. The primary objectives of Phase Ia are to determine the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended dose for expansion (RDE) of YF550. The primary objective of Phase Ib is to evaluate the antitumor activity of YF550 in participants with locally advanced or metastatic solid tumors. Blood samples will be collected from participants in both Phase Ia and Phase Ib to assess the pharmacokinetics (PK) of YF550.
- Conditions
- Solid Tumor (Phase I), Ovarian Cancer, NSCLC (Advanced Non-small Cell Lung Cancer), TNBC - Triple-Negative Breast Cancer
- Being tested
- YF550
- Keywords
- solid tumor
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YF550Drug
YF550 will be administered orally once daily in 21-day cycles,Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or no further clinical benefit.
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Experimental | Participants receive YF550 orally as monotherapy Receives: Drug: YF550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence and frequency of Treatment-emergent adverse events (TEAEs)
phase 1a
Measured: From first dose through 30 days after the last dose of study treatment(up to approximately 36 months)
The occurrence and frequency of Dose-limiting toxicities (DLTs) DLTs during the study
phase 1a
Measured: first cycle (each cycle is 21 days)
Objective remission rate (ORR) assessed by the investigator according to RECIST v1.1
Phase 1b
Measured: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Secondary outcomes (14)
Objective Response Rate (ORR) per RECIST v1.1
Phase 1a
Measured: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Disease Control Rate (DCR) per RECIST v1.1
Phase 1a and Phase 1b
Measured: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Progression-Free Survival (PFS) per RECIST v1.1
Phase 1a and Phase 1b
Measured: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Duration of Response (DOR) per RECIST v1.1
Phase 1a and Phase 1b
Measured: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause
Measured: approximately 36 months
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Time Point (AUC₀-t)
Area under the plasma concentration-time curve of YF550 from time zero to the last measurable time point.
Measured: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC₀-∞)
Area under the plasma concentration-time curve of YF550 from time zero extrapolated to infinity.
Measured: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Mean Residence Time (MRT)
Mean residence time of YF550 in plasma.
Measured: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration of YF550.
Measured: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Time to Maximum Observed Plasma Concentration (Tmax)
Time to reach the maximum observed plasma concentration of YF550.
Measured: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Terminal Elimination Half-Life (t½)
Terminal elimination half-life of YF550 in plasma.
Measured: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F)
Apparent volume of distribution of YF550 during the terminal phase following extravascular administration.
Measured: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Apparent Total Clearance Following Extravascular Administration (CL/F)
Apparent total clearance of YF550 following extravascular administration.
Measured: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Change from Baseline in QT/QTc Interval
Phase 1a
Measured: Up to 16 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor (Phase I)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Yiqi Beijing Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InventisBio Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Qinglei Gao, MD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894874
- Sponsor's protocol ID
- YF550-101
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YF550 in Participants With Locally Advanced or Metastatic Solid Tumors.
- ClinicalTrials.gov ID
- NCT07894874
- Acronym / sponsor ID
- YF550-101
- Conditions
- Solid Tumor (Phase I), Ovarian Cancer, NSCLC (Advanced Non-small Cell Lung Cancer), TNBC - Triple-Negative Breast Cancer
- Keywords
- solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- InventisBio Yiqi Beijing LimitedIndustry (pharma, biotech, devices)
- Collaborators
- InventisBio Co., Ltd
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 26 Oct 2026 (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 study is a open-label, multicenter clinical trials. The target population is participants with locally advanced or metastatic solid tumors. A total of 204 participants are planned to be included.
Detailed description
This study consists of two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion), with each treatment cycle lasting 21 days. Up to 84 participants will be enrolled in Phase Ia and up to 120 participants in Phase Ib. The primary objectives of Phase Ia are to determine the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended dose for expansion (RDE) of YF550. The primary objective of Phase Ib is to evaluate the antitumor activity of YF550 in participants with locally advanced or metastatic solid tumors. Blood samples will be collected from participants in both Phase Ia and Phase Ib to assess the pharmacokinetics (PK) of YF550.
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 study | Experimental | Drug: YF550Participants receive YF550 orally as monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18 years, male or female, with signed informed consent.
- Histologically or cytologically confirmed locally advanced, unresectable, and/or metastatic solid tumors.
- At least one measurable lesion per RECIST 1.1.
- Availability of an adequate and qualified tumor tissue sample.
- ECOG performance status score of ≤ 1.
Key exclusion criteria (12 listed)
- Prior or current treatment with the same class of drugs or related therapies as specified in the protocol.
- Unstable or progressive central nervous system (CNS) metastases, carcinomatous meningitis, brainstem metastases, and/or spinal cord compression.
- Clinically significant cardiovascular or cerebrovascular disease.
- History of interstitial lung disease (ILD), radiation pneumonitis, immune-related pneumonitis, or non-infectious pneumonitis requiring corticosteroid treatment; active non-infectious pneumonitis or interstitial lung changes, including ILD, radiation pneumonitis, or immune-related pneumonitis, at screening; or hospitalization or treatment with intravenous medications for any active infection within 4 weeks before the first dose of study drug.
- Gastrointestinal (GI) dysfunction or GI disease that may significantly affect the absorption or metabolism of orally administered study drug.
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 |
|---|---|---|
| YF550YF550 will be administered orally once daily in 21-day cycles,Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or no further clinical benefit. | Drug | single arm study |
Primary outcome
The occurrence and frequency of Treatment-emergent adverse events (TEAEs)
Time frame: From first dose through 30 days after the last dose of study treatment(up to approximately 36 months)
phase 1a
The occurrence and frequency of Dose-limiting toxicities (DLTs) DLTs during the study
Time frame: first cycle (each cycle is 21 days)
phase 1a
Objective remission rate (ORR) assessed by the investigator according to RECIST v1.1
Time frame: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Phase 1b
14 secondary outcomes
Objective Response Rate (ORR) per RECIST v1.1
Time frame: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Progression-Free Survival (PFS) per RECIST v1.1
Time frame: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Duration of Response (DOR) per RECIST v1.1
Time frame: Every 6 weeks (±7 days) during the first 48 weeks from Cycle 1 Day 1 (C1D1,each cycle is 21 days), and every 9 weeks (±7 days) thereafter (up to approximately 36 months)
Overall Survival (OS)
Time frame: approximately 36 months
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Time Point (AUC₀-t)
Time frame: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC₀-∞)
Time frame: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Mean Residence Time (MRT)
Time frame: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Maximum Observed Plasma Concentration (Cmax)
Time frame: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Terminal Elimination Half-Life (t½)
Time frame: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F)
Time frame: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Apparent Total Clearance Following Extravascular Administration (CL/F)
Time frame: every 2 weeks in Cycle 1 (each cycle is 21 days) and every 4 cycles until end of treatment (up to approximately 36 months)
Change from Baseline in QT/QTc Interval
Time frame: Up to 16 days after dosing
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 26 Oct 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.
Qinglei Gao, MD principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YF550 in people with Solid Tumor (Phase I) and Ovarian Cancer, run by InventisBio Yiqi Beijing Limited.
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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Qinglei Gao, MD (+8627-83662974, qlgao@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence and frequency of Treatment-emergent adverse events (TEAEs) (time frame: From first dose through 30 days after the last dose of study treatment(up to approximately 36 months)). 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 26 Oct 2026.