Trial Title:
A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors
NCT ID:
NCT06394414
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
YL201
Description:
YL201 (High dose, medium dose and low dose; Q3W) in Combination with Serplulimab
(4.5mg/kg; Q3W) with or without Platinum(70 mg/m2; Q3W)-based Chemotherapy.
Arm group label:
Part 1: Dose escalation
Arm group label:
Part2: Cohort Expansion
Other name:
Serplulimab
Other name:
Platinum
Summary:
This is a phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and
Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based
Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. The
study will include 2 parts: a dose escalation part (Part 1) followed by a cohort
expansion part (Part 2).
Part 1 will estimate the safety, tolerability and MTD/RED(s) of YL201 in combination with
serplulimab with or without platinum-based chemotherapy in selected subjects with
advanced solid tumors.
Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or
without platinum-based chemotherapy in selected subjects with advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1) Informed of the study before the start of the study and voluntarily sign their
name and date on the informed consent form (ICF).
2) Subjects will be enrolled in the dose-escalation phase: Advanced solid tumors,
like NPC, SCLC and etc.
3) Subjects will be enrolled in the dose-expansion phase: NPC, SCLC, NSCLC and
other advanced cancer.
4) According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1,
there must be at least one extracranial measurable lesion.
5) Archived or fresh tumor tissue samples can be provided. 6) Within 7 days before
the first dose, organ and bone marrow functions must meet the requirements.
7) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
by the United States of America standards.
8) Female subjects of childbearing potential must agree to use highly effective
contraception measures from screening throughout the duration of the study and
for at least 6 months after the last dose of the study drug. Male subjects must
agree to use highly effective contraception measures from screening throughout
the duration of the study and for at least 6 months after the last dose of the
study drug.
9) Subjects with expected survival ≥ 3 months. 10) Capable and willing to comply
with the study protocol's scheduled visits and procedures.
Exclusion Criteria:
-
1) Suitable for local radical treatment. 2) Previous Drug therapy targeting B7H3.
3) Previous Drug therapy with topoisomerase I inhibitors or ADCs composed of
topoisomerase I inhibitors.
4) Prior treatment with anti-PD-(L)1, other immune checkpoint inhibitors, immune
checkpoint agonists, or immunocellular therapies and other therapies targeting
tumor immunity mechanisms.
5) Toxicity from previous anticancer treatments has not resolved. 6) Concurrent
enrollment in another clinical study. 7) Inadequate washout period for prior
anticancer treatment before the first dose of study drug.
8) Underwent major surgery (excluding diagnostic surgery) or suffered serious
trauma.
9) Received allogeneic stem cell or solid organ transplant. 10) Active autoimmune
diseases requiring systemic treatment. 11) Received systemic steroids. 12)
Metastases to meninges or carcinomatous meningitis. 13) Brain metastasis or
spinal cord compression. 14) Uncontrolled or clinically significant
cardiovascular disease. 15) Clinically significant concomitant pulmonary
disease. 16) With uncontrolled third-space fluid. 17) History of
gastrointestinal perforation and / or fistula within 6 months prior to the
first dose.
18) Serious Infection prior to the first dose. 19) Known human immunodeficiency
virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
20) Any other primary malignancy before the first dose of study drug. 21) A history
of severe hypersensitivity reactions to the investigational product, inactive
ingredients in the formulation, or other monoclonal antibodies.
22) Women who are breastfeeding or pregnant as confirmed by pregnancy tests
performed within 3 days before the first dose.
23) Any illness, medical condition, organ system dysfunction, or social situation.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Coordinator Clinical operation director
Phone:
+86 0512-62858368
Email:
RA@medilinkthera.com
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Coordinator Clinical operation director
Phone:
+86 0512-62858368
Email:
RA@medilinkthera.com
Facility:
Name:
Affiliated Cancer Hospital of Guangxi Medical University
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Contact:
Last name:
Coordinator Clinical operation director
Phone:
+86 0512-62858368
Email:
RA@medilinkthera.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Union Hospital Tongji Medical College HuaZhong University of Science Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Coordinator Clinical operation director
Phone:
+86 0512-62858368
Email:
RA@medilinkthera.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Coordinator Clinical operation director
Phone:
+86 0512-62858368
Email:
RA@medilinkthera.com
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Coordinator Clinical operation director
Phone:
+86 0512-62858368
Email:
RA@medilinkthera.com
Facility:
Name:
Shandong Cancer Hospital and Institute
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Coordinator Clinical operation director
Phone:
+86 0512-62858368
Email:
RA@medilinkthera.com
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Coordinator Clinical operation director
Phone:
+86 0512-62858368
Email:
RA@medilinkthera.com
Start date:
April 17, 2024
Completion date:
April 29, 2030
Lead sponsor:
Agency:
MediLink Therapeutics (Suzhou) Co., Ltd.
Agency class:
Industry
Source:
MediLink Therapeutics (Suzhou) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06394414
