Solid TumorsPhase 1NCT07903207
First-in-Human, Multicenter, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YL-18319 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
A Phase 1 study testing YL-18319 in people with Solid Tumors and Ovarian, run by Shanghai YingLi Pharmaceutical Co. Ltd..
Trial summary
First-in-Human, multicenter, phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of YL-18319 monotherapy treatment in patients with advanced solid tumors who have progressed or are intolerant to current standard-of-care therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Ovarian
- What is being tested?
- YL-18319
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Jun 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
- Patients with advanced solid tumors that is unresectable or metastatic who have no standard therapies, or have progressed on or intolerable to standard therapies. Preferential enrollment consideration will be made for patients (at least 2 patients per cohort) with known genetic alterations causing deficiencies of BRCA1, BRCA2, and/or Homologous Recombination Defective (HRD), or selected gene mutations of genome instability or cell cycle control, based on the mechanism of YL-18319.
- Patient has at least 1 measurable target lesion or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Demonstrate adequate organ function as defined below. The following screening laboratories should be performed within 7 days of study treatment initiation.
- Absolute neutrophil count (ANC) ≥1.5 × 109/L Platelets ≥100 × 109/L Hemoglobin ≥9 g/dL Measured and/or Calculated creatinine clearance (CrCl) (Cockroft-Gault) ≥ 60 mL/min Total bilirubin ≤1.5 × ULN (patients with Gilbert's syndrome, total bilirubin ≤3.0 × ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 × ULN for patients with liver metastases
- Has an ECOG performance status of 0-1.
- Life expectancy at least 3 months.
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- Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and at least 3 months following last day study drug administration.
- Male patients of childbearing potential must be surgically sterile or must agree to use adequate method of contraception during the study and at least 3 months following the last day of study drug administration.
- Age ≥18 years at screening.
- Able and willing to provide written informed consent and to comply with all protocol-required visits, assessments, and procedures.
- Washout from prior anti-tumor therapy:
- Cytotoxic therapies ≥ 3 weeks Mitomycin C or nitrosoureas ≥ 6 weeks Small molecule agents ≥2 weeks or 5x T1/2, whichever is longer Biologic agents (e.g., antibodies) ≥ 4weeks Immunotherapy (e.g., CTLA4, PD-1, PD-L1 inhibitors) ≥ 4 weeks Radiotherapy ≥ 2 weeks Limited field radiotherapy or palliative radiotherapy ≥ 2 weeks Major surgery, excluding biopsy ≥ 4 weeks (exception: patients may enroll if fully recovered without intolerable or clinically significant adverse effects, but at least 14 days must have elapsed between major surgery and first study drug administration) Study drug with an investigational product, or non-approved use of a drug or device ≥ 4 weeks (≥2 weeks or 5x T1/2, whichever is longer for small molecule agents)
Who cannot join
- Known symptomatic brain metastases requiring dexamethasone >4mg (or equivalent) or requiring steroid dose increase within 14 days prior to the first dose of YL-18319.
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- Unresolved toxicities from prior therapy, defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline, with exception of endocrinopathies from prior therapy and successfully treated (such as hypothyroidism), alopecia, vitiligo, and ≤ grade 2 peripheral neuropathy.
- Human immunodeficiency virus (HIV) infection with a current or a known history of AIDS-defining illness or HIV infection with a CD4+ T cell count <350 cells/µL and an HIV viral load more than 400 copies/µL.
- Patients with active viral (any etiology) hepatitis are excluded. However, patients with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer <1000 cps/mL or 200 IU/mL), and are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor. Patients with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have a viral load below the limit of quantitation may be eligible and should be discussed with the Medical Monitor.
- Any of the following cardiac criteria experienced currently or within the last 6 months:
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- Congestive heart failure (New York Heart Association ≥ Class 2).
- Any clinically significant abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block or third-degree heart block.
- Acute coronary syndrome within 6 months.
- Clinically significant cardiac arrhythmia.
- Mean QTC interval corrected (Frederica) for heart rate >470 ms.
- Left ventricular ejection fraction (LVEF) <50% or the lower limit of normal (per institutional standard).
- Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, as determined by the investigator.
- Any condition that impairs a patient's ability to swallow whole pills. Presence of an active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of YL-18319, as determined by the investigator.
- Known pulmonary interstitial disease or pulmonary interstitial fibrosis
- An active additional malignancy that is progressing or requires active treatment within the past 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Known allergy to any component of YL-18319.
- Patients who are pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
- History or evidence of any other clinically significant condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, would be a risk to patient safety or interfere with the study evaluation, procedures or completion.
- Patients receiving proton pump inhibitors (PPIs), strong cytochrome P450 (CYP)3A inhibitors and inducers, or P-glycoprotein (P-gp) inhibitors. Patients should not receive PPIs within 7 days prior to first dose of study drug. Strong CYP3A inducers or inhibitors or strong P-gp inhibitors should not be given within 6 half-lives prior to first dose of study drug
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
First-in-Human, multicenter, phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of YL-18319 monotherapy treatment in patients with advanced solid tumors who have progressed or are intolerant to current standard-of-care therapies.
Read the detailed description
This study consists of two parts: dose escalation and dose expansion. Part 1 Dose-Escalation:
YL-18319 will be administered as a single oral agent in patients with advanced or metastatic solid tumors. A Bayesian Optimal Interval (BOIN) design for the dose escalation will be used and a total of 6 dose levels at starting dose of 20 mg QD are planned. One cycle is defined as 21 days. The DLT observation period is one cycle. The actual number of dose levels to be explored in this study will be determined by emerging safety, tolerability, PK, PD and preliminary efficacy data. Each cohort will enroll 3 to 4 patients initially to ensure at least 3 patients are evaluable for DLT. Evaluation of 3 DLT-evaluable patients is required prior to proceeding to the next dose level. The study will identify a maximum tolerated dose (MTD) if possible, with safety and tolerability data.
Part 2 Dose Expansion:
The dose expansion part is to evaluate the preliminary anti-tumor activity of YL-18319 monotherapy treatment and to further assess the safety and tolerability at the selected dose(s) and/or dosing schedules determined by SMC.
YL-18319 will be given as a single oral agent in patients with advanced or metastatic solid tumors. Cancers with known genome instability characteristics, such as ovarian, breast, endometrial, and other types, as well as patients with tumors harboring BRCA1/2 mutations or alterations, Homologous Recombination Deficient (HRD) tumors and/or other defects in genome stability may potentially be examined in expansion cohorts. Also, patients who have previously received PARP inhibitor therapies and/or therapies targeting other DNA repair and cell cycle checkpoint proteins may be evaluated.
The optimal doses, dosing schedules, cancer types and number of patients to be evaluated in part 2 will be specified through a protocol amendment.
- Conditions
- Solid Tumors, Ovarian
- Being tested
- YL-18319
- Keywords
- YL-18319, Solid Tumors, BRCA1/2 mutations or alterations, HRD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL-18319Drug
The starting dose of YL-18319 for the study is 20mg once daily (QD), One cycle is 21 days, until disease progression (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), unacceptable toxicity, or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Dose-Escalation:
YL-18319 will be administered as a single oral agent in patients with advanced or metastatic solid tumors. A Bayesian Optimal Interval (BOIN) design for the dose escalation will be used and a total of 6 dose levels at starting dose of 20 mg QD are planned. One cycle is defined as 21 days. The DLT observation period is one cycle. The actual number of dose levels to be explored in this study will be determined by emerging safety, tolerability, PK, PD and preliminary efficacy data.
Dose Expansion:
The dose expansion part is to evaluate the preliminary anti-tumor activity of YL-18319 monotherapy treatment and to further assess the safety and tolerability at the selected dose(s) and/or dosing schedules determined by SMC.
The optimal doses, dosing schedules, cancer types and number of patients to be evaluated in part 2 will be specified through a protocol amendment. Receives: Drug: YL-18319 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D
To characterize the safety and tolerability of YL 18319 monotherapy, and to identify the maximum tolerated dose (MTD) if possible and optimal doses for RP2D.
Measured: 2 years
Secondary outcomes (1)
ORR
To assess the preliminary anti-tumor activity of YL 18319 in patients by measuring objective response rate ORR using RECIST 1.1
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- Model description
- Part 1 Dose-Escalation: YL-18319 will be administered as a single oral agent in patients with advanced or metastatic solid tumors. A Bayesian Optimal Interval (BOIN) design for the dose escalation will be used and a total of 6 dose levels at starting dose of 20 mg QD are planned. One cycle is defined as 21 days. The DLT observation period is one cycle. The actual number of dose levels to be explored in this study will be determined by emerging safety, tolerability, PK, PD and preliminary efficacy data.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ning Li, PhD in Medicine, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesHongtu zhao, PhD in Medicine, Principal investigator, Henan Cancer HospitalJuan Li, PhD in Medicine, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903207
- Sponsor's protocol ID
- YL-18319-001
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Publications
Harrision, D., P. Gravells, R. Thompson and H. E. Bryant (2020). "Poly(ADP-Ribose) Glycohydrolase (PARG) vs. Poly(ADP-Ribose) Polymerase (PARP) - Function in Genome Maintenance and Relevance of Inhibitors for Anti-cancer Therapy." Front Mol Biosci 7: 191. [2] Houl, J. H., Z. Ye, C. A. Brosey, L. P. F. Balapiti-Modarage, S. Namjoshi, A. Bacolla, D. Laverty, B. L. Walker, Y. Pourfarjam, L. S. Warden, N. Babu Chinnam, D. Moiani, R. A. Stegeman, M. K. Chen, M. C. Hung, Z. D. Nagel, T. Ellenberger, I. K. Kim, D. E. Jones, Z. Ahmed and J. A. Tainer (2019). "Selective small molecule PARG inhibitor causes replication fork stalling and cancer cell death." Nat Commun 10(1): 5654. [3] Heeke, A. L., M. J. Pishvaian, F. Lynce, J. Xiu, J. R. Brody, W. J. Chen, T. M. Baker, J. L. Marshall and C. Isaacs (2018). "Prevalence of Homologous Recombination-Related Gene Mutations Across Multiple Cancer Types." JCO Precis Oncol 2018. [4] Pillay, N., A. Tighe, L. Nelson, S. Littler, C. Coulson-Gilmer, N. Bah, A. Golder, B. Bakker, D. C. J. Spierings, D. I. James, K. M. Smith, A. M. Jordan, R. D. Morgan, D. J. Ogilvie, F. Foijer, D. A. Jackson and S. S. Taylor (2019). "DNA Replication Vulnerabilities Render Ovarian Cancer Cells Sensitive to Poly(ADP-Ribose) Glycohydrolase Inhibitors." Cancer Cell 35(3): 519-533.e518. [5] Cybulla, E. and A. Vindigni (2023). "Leveraging the replication stress response to optimize cancer therapy." Nat Rev Cancer 23(1): 6-24. [6] Herold, S., B. Herkert and M. Eilers (2009). "Facilitating replication under stress: an oncogenic function of MYC?" Nat Rev Cancer 9(6): 441-444. [7] Khamidullina, A. I., Y. E. Abramenko, A. V. Bruter and V. V. Tatarskiy (2024). "Key Proteins of Replication Stress Response and Cell Cycle Control as Cancer Therapy Targets." Int J Mol Sci 25(2). [8] Slade, D. (2020). "PARP and PARG inhibitors in cancer treatment." Genes Dev 34(5-6): 360-394. [9] Yuan, Y., K. R. Hess, S. G. Hilsenbeck and M. R. Gilbert (2016). "Bayesian Optimal Int
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Multicenter, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YL-18319 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07903207
- Acronym / sponsor ID
- YL-18319-001
- Conditions
- Solid Tumors, Ovarian
- Keywords
- YL-18319, Solid Tumors, BRCA1/2 mutations or alterations, HRD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 29 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.
First-in-Human, multicenter, phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of YL-18319 monotherapy treatment in patients with advanced solid tumors who have progressed or are intolerant to current standard-of-care therapies.
Detailed description
This study consists of two parts: dose escalation and dose expansion. Part 1 Dose-Escalation:
YL-18319 will be administered as a single oral agent in patients with advanced or metastatic solid tumors. A Bayesian Optimal Interval (BOIN) design for the dose escalation will be used and a total of 6 dose levels at starting dose of 20 mg QD are planned. One cycle is defined as 21 days. The DLT observation period is one cycle. The actual number of dose levels to be explored in this study will be determined by emerging safety, tolerability, PK, PD and preliminary efficacy data. Each cohort will enroll 3 to 4 patients initially to ensure at least 3 patients are evaluable for DLT. Evaluation of 3 DLT-evaluable patients is required prior to proceeding to the next dose level. The study will identify a maximum tolerated dose (MTD) if possible, with safety and tolerability data.
Part 2 Dose Expansion:
The dose expansion part is to evaluate the preliminary anti-tumor activity of YL-18319 monotherapy treatment and to further assess the safety and tolerability at the selected dose(s) and/or dosing schedules determined by SMC.
YL-18319 will be given as a single oral agent in patients with advanced or metastatic solid tumors. Cancers with known genome instability characteristics, such as ovarian, breast, endometrial, and other types, as well as patients with tumors harboring BRCA1/2 mutations or alterations, Homologous Recombination Deficient (HRD) tumors and/or other defects in genome stability may potentially be examined in expansion cohorts. Also, patients who have previously received PARP inhibitor therapies and/or therapies targeting other DNA repair and cell cycle checkpoint proteins may be evaluated.
The optimal doses, dosing schedules, cancer types and number of patients to be evaluated in part 2 will be specified through a protocol amendment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Part 1 Dose-Escalation: YL-18319 will be administered as a single oral agent in patients with advanced or metastatic solid tumors. A Bayesian Optimal Interval (BOIN) design for the dose escalation will be used and a total of 6 dose levels at starting dose of 20 mg QD are planned. One cycle is defined as 21 days. The DLT observation period is one cycle. The actual number of dose levels to be explored in this study will be determined by emerging safety, tolerability, PK, PD and preliminary efficacy data.
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: YL-18319Dose-Escalation: YL-18319 will be administered as a single oral agent in patients with advanced or metastatic solid tumors. A Bayesian Optimal Interval (BOIN) design for the dose escalation will be used and a total of 6 dose levels at starting dose of 20 mg QD are planned. One cycle is defined as 21 days. The DLT observation period is one cycle. The actual number of dose levels to be explored in this study will be determined by emerging safety, tolerability, PK, PD and preliminary efficacy data. Dose Expansion: The dose expansion part is to evaluate the preliminary anti-tumor activity of YL-18319 monotherapy treatment and to further assess the safety and tolerability at the selected dose(s) and/or dosing schedules determined by SMC. The optimal doses, dosing schedules, cancer types and number of patients to be evaluated in part 2 will be specified through a protocol amendment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with advanced solid tumors that is unresectable or metastatic who have no standard therapies, or have progressed on or intolerable to standard therapies. Preferential enrollment consideration will be made for patients (at least 2 patients per cohort) with known genetic alterations causing deficiencies of BRCA1, BRCA2, and/or Homologous Recombination Defective (HRD), or selected gene mutations of genome instability or cell cycle control, based on the mechanism of YL-18319.
- Patient has at least 1 measurable target lesion or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Demonstrate adequate organ function as defined below. The following screening laboratories should be performed within 7 days of study treatment initiation.
- Absolute neutrophil count (ANC) ≥1.5 × 109/L Platelets ≥100 × 109/L Hemoglobin ≥9 g/dL Measured and/or Calculated creatinine clearance (CrCl) (Cockroft-Gault) ≥ 60 mL/min Total bilirubin ≤1.5 × ULN (patients with Gilbert's syndrome, total bilirubin ≤3.0 × ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 × ULN for patients with liver metastases
- Has an ECOG performance status of 0-1.
Key exclusion criteria (20 listed)
- Known symptomatic brain metastases requiring dexamethasone >4mg (or equivalent) or requiring steroid dose increase within 14 days prior to the first dose of YL-18319.
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- Unresolved toxicities from prior therapy, defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline, with exception of endocrinopathies from prior therapy and successfully treated (such as hypothyroidism), alopecia, vitiligo, and ≤ grade 2 peripheral neuropathy.
- Human immunodeficiency virus (HIV) infection with a current or a known history of AIDS-defining illness or HIV infection with a CD4+ T cell count <350 cells/µL and an HIV viral load more than 400 copies/µL.
- Patients with active viral (any etiology) hepatitis are excluded. However, patients with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer <1000 cps/mL or 200 IU/mL), and are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor. Patients with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have a viral load below the limit of quantitation may be eligible and should be discussed with the Medical Monitor.
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 |
|---|---|---|
| YL-18319The starting dose of YL-18319 for the study is 20mg once daily (QD), One cycle is 21 days, until disease progression (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), unacceptable toxicity, or withdrawal of consent. | Drug | treatment group |
Primary outcome
RP2D
Time frame: 2 years
To characterize the safety and tolerability of YL 18319 monotherapy, and to identify the maximum tolerated dose (MTD) if possible and optimal doses for RP2D.
1 secondary outcome
ORR
Time frame: 2 YEARS
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 29 Oct 2026.
- BackgroundHarrision, D., P. Gravells, R. Thompson and H. E. Bryant (2020). "Poly(ADP-Ribose) Glycohydrolase (PARG) vs. Poly(ADP-Ribose) Polymerase (PARP) - Function in Genome Maintenance and Relevance of Inhibitors for Anti-cancer Therapy." Front Mol Biosci 7: 191. [2] Houl, J. H., Z. Ye, C. A. Brosey, L. P. F. Balapiti-Modarage, S. Namjoshi, A. Bacolla, D. Laverty, B. L. Walker, Y. Pourfarjam, L. S. Warden, N. Babu Chinnam, D. Moiani, R. A. Stegeman, M. K. Chen, M. C. Hung, Z. D. Nagel, T. Ellenberger, I. K. Kim, D. E. Jones, Z. Ahmed and J. A. Tainer (2019). "Selective small molecule PARG inhibitor causes replication fork stalling and cancer cell death." Nat Commun 10(1): 5654. [3] Heeke, A. L., M. J. Pishvaian, F. Lynce, J. Xiu, J. R. Brody, W. J. Chen, T. M. Baker, J. L. Marshall and C. Isaacs (2018). "Prevalence of Homologous Recombination-Related Gene Mutations Across Multiple Cancer Types." JCO Precis Oncol 2018. [4] Pillay, N., A. Tighe, L. Nelson, S. Littler, C. Coulson-Gilmer, N. Bah, A. Golder, B. Bakker, D. C. J. Spierings, D. I. James, K. M. Smith, A. M. Jordan, R. D. Morgan, D. J. Ogilvie, F. Foijer, D. A. Jackson and S. S. Taylor (2019). "DNA Replication Vulnerabilities Render Ovarian Cancer Cells Sensitive to Poly(ADP-Ribose) Glycohydrolase Inhibitors." Cancer Cell 35(3): 519-533.e518. [5] Cybulla, E. and A. Vindigni (2023). "Leveraging the replication stress response to optimize cancer therapy." Nat Rev Cancer 23(1): 6-24. [6] Herold, S., B. Herkert and M. Eilers (2009). "Facilitating replication under stress: an oncogenic function of MYC?" Nat Rev Cancer 9(6): 441-444. [7] Khamidullina, A. I., Y. E. Abramenko, A. V. Bruter and V. V. Tatarskiy (2024). "Key Proteins of Replication Stress Response and Cell Cycle Control as Cancer Therapy Targets." Int J Mol Sci 25(2). [8] Slade, D. (2020). "PARP and PARG inhibitors in cancer treatment." Genes Dev 34(5-6): 360-394. [9] Yuan, Y., K. R. Hess, S. G. Hilsenbeck and M. R. Gilbert (2016). "Bayesian Optimal Int
- Individual participant dataSharing planned: No. No plan to share IPD.
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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.
Ning Li, PhD in Medicine principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Hongtu zhao, PhD in Medicine principal investigator
Henan Cancer Hospital
Juan Li, PhD in Medicine principal investigator
Shandong Cancer Hospital and Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YL-18319 in people with Solid Tumors and Ovarian, run by Shanghai YingLi Pharmaceutical Co. Ltd..
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 13 inclusion and 20 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 29 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 Ning Li, PhD in Medicine (010-87787210, liningnci@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07903207, which also lists 1 linked publication.
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 29 Oct 2026.