YL242 treatment for people with advanced solid tumors
A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.
PHASE1; PHASE2 · MediLink Therapeutics (Suzhou) Co., Ltd. · NCT07197827
This trial will test YL242 alone and with pembrolizumab or chemotherapy in adults with advanced or metastatic solid tumors to check safety and early activity.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. (industry) |
| Locations | 15 sites (New Haven, Connecticut and 14 other locations) |
| Trial ID | NCT07197827 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter Phase 1/2 trial tests YL242 as monotherapy and in combination with pembrolizumab and chemotherapy across multiple cohorts of adults with advanced solid tumors. Phase 1 will use dose-escalation to define safety, tolerability, and recommended doses, followed by expansion cohorts in Phase 2 that enroll tumor-specific groups such as non-squamous NSCLC, colorectal, and gastric cancers. Eligible participants generally must be adults with ECOG 0–1 and adequate organ function, with most cohorts requiring prior systemic therapy while some cohorts enroll treatment‑naïve patients. Primary endpoints focus on safety and tolerability, with secondary endpoints capturing preliminary anti-tumor activity and pharmacokinetics.
Who should consider this trial
Good fit: Adults (≥18) with advanced or metastatic solid tumors, ECOG performance status 0–1, and adequate organ and bone marrow function, with cohort-specific requirements for prior therapy as noted in the protocol.
Not a fit: Patients intolerant to prior topoisomerase I inhibitors or ADCs carrying topoisomerase I payloads, or those with uncontrolled cardiovascular/cerebrovascular disease, significant pulmonary disease, or leptomeningeal carcinomatosis, are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, YL242 could offer a new targeted treatment option that helps control tumors in patients with advanced disease who have limited options.
How similar studies have performed: Antibody–drug conjugates and VEGF-targeting approaches have shown clinical activity in several cancers, but YL242 is a novel agent with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥18 years. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Adequate organ and bone marrow function * Tumor type: Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy; Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy Exclusion Criteria: * Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor * Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases * Clinically significant concomitant pulmonary disease * A history of leptomeningeal carcinomatosis or carcinomatous meningitis * Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results
Where this trial is running
New Haven, Connecticut and 14 other locations
- US-201 — New Haven, Connecticut, United States (NOT_YET_RECRUITING)
- US-202 — Sarasota, Florida, United States (RECRUITING)
- US-204 — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- US-206 — Grand Rapids, Michigan, United States (RECRUITING)
- US-205 — Nashville, Tennessee, United States (RECRUITING)
- US-203 — Houston, Texas, United States (NOT_YET_RECRUITING)
- US-207 — San Antonio, Texas, United States (NOT_YET_RECRUITING)
- AUS-101 — Liverpool, New South Wales, Australia (NOT_YET_RECRUITING)
- AUS-102 — Darlinghurst, Victoria, Australia (RECRUITING)
- AUS-104 — Fitzroy, Victoria, Australia (NOT_YET_RECRUITING)
- AUS-103 — Heidelberg, Victoria, Australia (NOT_YET_RECRUITING)
- AUS-105 — Nedlands, Western Australia, Australia (NOT_YET_RECRUITING)
- CN-303 — Harbin, Heilongjiang, China (RECRUITING)
- CN-301 — Shanghai, Shanghai Municipality, China (RECRUITING)
- CN-302 — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Medilink Study Team
- Email: clinicaltrials@medilinkthera.com
- Phone: +86 0512-62858368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumor, Oncology, VEGF, Antibody drug conjugate, Developmental Phase I/II