Actively Recruiting
GenSci143 in Participants With Advanced Solid Tumors
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-01-05
180
Participants Needed
9
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors
CONDITIONS
Official Title
GenSci143 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form.
- Male or female participants 18 years or older at the time of consent.
- Have histologically or cytologically confirmed recurrent or metastatic advanced solid tumors who have progressed after standard therapy, are intolerant to standard therapy, or have no standard therapy available.
- For dose expansion, have either metastatic castration-resistant prostate cancer (mCRPC) with prior novel hormonal therapy and chemotherapy progression/intolerance, or other advanced solid tumors with similar treatment history.
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Have at least one evaluable tumor lesion per RECIST v1.1; mCRPC patients with bone-only disease may be eligible case-by-case.
- Able to provide archival or fresh biopsy tumor samples.
- Adequate organ function including specific blood counts, liver, kidney, and coagulation parameters as defined.
- Toxicities from prior anticancer therapy must have resolved to Grade 1 or less.
- Women of childbearing potential must have negative pregnancy test and agree to contraceptive use; men must agree to contraceptive use and not donate sperm during and up to 6 months after treatment.
You will not qualify if you...
- Known spinal cord compression or active central nervous system metastases unless stable and asymptomatic.
- History of other malignancies within the past 3 years.
- Unstable thrombotic events within 6 months prior to treatment.
- Uncontrolled or significant cardiovascular disease.
- Uncontrolled pleural fluid, pericardial effusion, or ascites requiring recent intervention.
- History or current interstitial lung disease or pneumonitis requiring steroids.
- Pregnant, breastfeeding, or planning pregnancy.
- Active hepatitis B or C infection.
- Known HIV infection.
- Uncontrolled infection requiring systemic therapy within 1 week prior to treatment.
- Recent major surgery, radiotherapy, immunotherapy, chemotherapy, or antibody therapy within specified time frames.
- Recent live vaccine within 4 weeks before treatment or planned during study.
- History of allogeneic hematopoietic stem cell or solid organ transplantation.
- Prior treatment with topoisomerase inhibitors or related antibody-drug conjugates.
- History of severe allergic reactions to GenSci143, its components, or similar monoclonal antibodies.
- Any uncontrolled illness or condition judged by the investigator as ineligible for participation.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 451191
Actively Recruiting
2
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
3
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Not Yet Recruiting
4
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
5
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
6
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
7
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
8
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
9
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310024
Not Yet Recruiting
Research Team
D
Dingwei Ye
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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