A Study of YL202 in Patients With Advanced Solid Tumors

NCT07202364 | Recruiting Phase 2

• 1 other identifier: YL202-CN-203-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in selected patients with advanced solid tumors.

Conditions

Non Small Cell Lung Cancer; Colorectal Cancer; Cervical Cancer; Locally Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR)

  Up to approximately 3 years

Secondary Outcomes (7)

• Progression-free survival (PFS)

  Up to approximately 3 years

• Depth of response (DpR)

  Up to approximately 3 years

• Disease control rate (DCR)

  Up to approximately 3 years

• Duration of response (DoR)

  Up to approximately 3 years

• Time to response (TTR)

  Up to approximately 3 years

Study Arms (2)

Cohort EGFRm NSCLC, AGA-nsq-NSCLC, Cervical Cancer and Cervical Cancer/1.6mg

EXPERIMENTAL

This includes a dose-exploration period and a dose-expansion period.

Drug: YL202

Cohort Colorectal Cancer

EXPERIMENTAL

This includes a dose-exploration period and a dose-expansion period. Participants in Cohort Colorectal Cance will be randomized in a 1:1 ratio to one of the two dose levels.

Drug: YL202

Interventions

YL202 DRUG

YL202 will be intravenously infused over 60±10 min

Cohort Colorectal Cancer; Cohort EGFRm NSCLC, AGA-nsq-NSCLC, Cervical Cancer and Cervical Cancer/1.6mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all the following criteria to be included in the study:
• Subjects who are aware of relevant study information prior to the start of the study, and voluntarily sign and date on the informed consent form (ICF).
• Subjects aged ≥18 years at the time of giving informed consent
• Body mass index (BMI) within the range of 18 to 32 kg/m2.
• Subjects with histologically or cytologically confirmed non-Sq NSCLC/CRC/CC or other advanced solid tumor, and had received 1-2 lines of systemic therapy in the advanced/metastatic setting
• There is at least one extracranial measurable lesion as the target lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Archived or fresh tumor tissue samples are available.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• The function of organs and bone marrow meets the requirements within 7 days prior to the first dose
• Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.
• Expected survival ≥3 months.
• Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.

You may not qualify if:

• Subjects who meet any of the following criteria should be excluded from the study:
• Prior drug therapy targeting HER3
• Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors).
• Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
• The washout period from the previous anti-tumor therapy is insufficient prior to the first dose of the investigational product.
• Patients who received major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of the investigational product or those who are expected to receive major surgery during the study.
• Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
• Prior treatment with systemic steroids (prednisone \>10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational product.
• Patients who received any live vaccine within 4 weeks prior to the first dose of the investigational product or those who plan to receive live vaccine during the study period.
• Meningeal metastasis or cancerous meningitis.
• Brain metastasis or spinal cord compression.
• Patients with uncontrolled or clinically significant cardiovascular diseases.
• Clinically significant complicated pulmonary disorders.
• Medical history of hepatic encephalopathy within 6 months prior to the first dose.
• Subjects with active or chronic corneal disorders, or other active eye disorders requiring continuous treatment, or any clinically significant corneal disorders that preclude adequate monitoring of drug-induced keratopathy.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

Hunan Provincial Tumor Hospital

Changsha, Hunan, 410006, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

yongchang zhang, Ph.D.

CONTACT

+86 13873123436; zhangyongchang@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (1)