What this study is
This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors.
What's being tested
- YL242
Intervention · DRUG
The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.
- YL242; Pembrolizumab
Intervention · DRUG
The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. Pembrolizumab will be administered subsequent to YL242.
- YL242; 5-FU; LV
Intervention · DRUG
The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. LV and 5-FU will be sequentially administered following YL242.
- YL242; Pembrolizumab; 5-FU
Intervention · DRUG
The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. YL242 will be administered via Intravenous (IV) Infusion. Pembrolizumab and 5-FU will be administered in sequence after YL242.
Study details
- Official title
- 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.
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Conditions
- Advanced Solid Tumor
- Enrolling
- 424 people
- Starts
- 2025-09-22
- Est. completion
- 2028-11
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (15)
15 openContact for every open site
- study coordinator · Contact
US-201
New Haven, Connecticut, United States
Not yet recruitingUS-202
Sarasota, Florida, United States
RecruitingUS-204
Boston, Massachusetts, United States
Not yet recruitingUS-206
Grand Rapids, Michigan, United States
RecruitingUS-205
Nashville, Tennessee, United States
RecruitingUS-203
Houston, Texas, United States
Not yet recruitingUS-207
San Antonio, Texas, United States
Not yet recruiting
8 sites outside the US
AUS-101
Liverpool, New South Wales, Australia
Not yet recruitingAUS-102
Darlinghurst, Victoria, Australia
RecruitingAUS-104
Fitzroy, Victoria, Australia
Not yet recruitingAUS-103
Heidelberg, Victoria, Australia
Not yet recruitingAUS-105
Nedlands, Western Australia, Australia
Not yet recruitingCN-303
Harbin, Heilongjiang, China
RecruitingCN-301
Shanghai, Shanghai Municipality, China
RecruitingCN-302
Hangzhou, Zhejiang, China
Recruiting
Study team
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID YL242-INT-101-01
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.