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Not yet recruitingNCT07894874Updated Oct 26, 2026

A Study to Evaluate YF550 in Participants With Locally Advanced or Metastatic Solid Tumors.

A Phase 1 interventional study of YF550 in Solid Tumor (Phase I), Ovarian Cancer and NSCLC (Advanced Non-small Cell Lung Cancer), sponsored by InventisBio Yiqi Beijing Limited. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by InventisBio Yiqi Beijing Limited · Phase 1, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
204
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Solid Tumor (Phase I)
  • Ovarian Cancer
  • NSCLC (Advanced Non-small Cell Lung Cancer)
  • TNBC - Triple-Negative Breast Cancer

Keywords

  • solid tumor
03

In context

Ovarian Neoplasms

2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.

This study's planned enrollment of 204 is above the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

This is the only study on the registry with InventisBio Yiqi Beijing Limited 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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

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

Study arms

  • Experimental
    single arm study

    Participants receive YF550 orally as monotherapy

    Drug: YF550

Interventions

  • DrugYF550

    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.

06

What researchers measure

Primary outcomes

  1. The occurrence and frequency of Treatment-emergent adverse events (TEAEs)

    phase 1a

    Time frame: From first dose through 30 days after the last dose of study treatment(up to approximately 36 months)

  2. The occurrence and frequency of Dose-limiting toxicities (DLTs) DLTs during the study

    phase 1a

    Time frame: first cycle (each cycle is 21 days)

  3. Objective remission rate (ORR) assessed by the investigator according to RECIST v1.1

    Phase 1b

    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)

Secondary outcomes

  1. Objective Response Rate (ORR) per RECIST v1.1

    Phase 1a

    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)

  2. Disease Control Rate (DCR) per RECIST v1.1

    Phase 1a and Phase 1b

    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)

  3. Progression-Free Survival (PFS) per RECIST v1.1

    Phase 1a and Phase 1b

    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)

  4. Duration of Response (DOR) per RECIST v1.1

    Phase 1a and Phase 1b

    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)

  5. Overall Survival (OS)

    Duration from the date of initial treatment to the date of death due to any cause

    Time frame: approximately 36 months

  6. 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.

    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)

  7. 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.

    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)

  8. Mean Residence Time (MRT)

    Mean residence time of YF550 in plasma.

    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)

  9. Maximum Observed Plasma Concentration (Cmax)

    Maximum observed plasma concentration of YF550.

    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)

  10. Time to Maximum Observed Plasma Concentration (Tmax)

    Time to reach the maximum observed plasma concentration of YF550.

    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)

  11. Terminal Elimination Half-Life (t½)

    Terminal elimination half-life of YF550 in plasma.

    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)

  12. 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.

    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)

  13. Apparent Total Clearance Following Extravascular Administration (CL/F)

    Apparent total clearance of YF550 following extravascular administration.

    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)

  14. Change from Baseline in QT/QTc Interval

    Phase 1a

    Time frame: Up to 16 days after dosing

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07894874
Lead sponsor
InventisBio Yiqi Beijing Limited
Collaborators
InventisBio Co., Ltd
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Oct 26, 2026

Study contacts

Qinglei Gao, MD
Contact
qlgao@tjh.tjmu.edu.cn
+8627-83662974
Debo Nie
Contact
debo.nie@inventisbio.com
+86-15921709901
Qinglei Gao, MD
principal investigator · Tongji Hospital

Oversight

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

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Discussion

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