Advanced Solid TumorsPhase 1NCT07252414
GenSci143 in Participants With Advanced Solid Tumors
A Phase 1 study testing GenSci143 for injection in people with Advanced Solid Tumors, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 13 sites in 2 countries.
Trial summary
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- GenSci143 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 20 Dec 2025to 30 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the ICF.
- Male or female participants ≥18 years old at the time of signing the ICF.
- Meet the requirements of tumor types as outlined below:
- Dose escalation: Participants with histologically or cytologically documented recurrent or metastatic advanced solid tumors, and who have progressed after standard therapy, are intolerant to standard therapy, or have no standard therapy available.
- Dose expansion:
- Cohort 1: Participants with histologically or cytologically documented mCRPC，who had received at least one prior novel hormonal therapy (including but not limited to abiraterone, enzalutamide, darolutamide, apalutamide) and progressed on standard chemotherapy regimens, are intolerant to chemotherapy, or decline chemotherapy.
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- Cohort 2: Participants with histologically or cytologically documented other advanced solid tumors, and who have progressed after standard therapy, are intolerant to standard treatment, or have no standard therapy available.
- Life expectancy of ≥ 12 weeks.
- ECOG PS 0-1
- Have at least 1 evaluable tumor lesion according to RECIST v1.1. Participants with mCRPC who have bone only disease may be eligible on a case-by-case basis after discussion between the investigator and Sponsor
- Able to provide either archival or fresh biopsy formalin-fixed paraffin-embedded (FFPE) tumor samples.
- Adequate organ function at the time of screening, as outlined below:
- Hematology: Absolute neutrophil count (ANC) ≥ 1.5×109/L (1500/µL); platelet count (PLT)≥100×109/L (100,000/µL); hemoglobin (HGB) ≥ 90 g/L (9 g/dL) (have not received granulocyte colony-stimulating factor (G-CSF) within 7 days before the first dose of GenSci143, and have not received granulocyte-macrophage colony-stimulating factor (GM-CSF), blood transfusion, erythropoietin (EPO), platelet transfusion, thrombopoietin (TPO), or interleukin-11 (IL-11) within 14 days before the first dose of GenSci143).
- Liver function: Serum total bilirubin (TBIL) ≤ 1.5 upper limit of normal (ULN), and serum TBIL≤ 3×ULN in the presence of liver metastasis or documented Gilbert syndrome. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN if no liver metastasis; ALT and AST≤ 5×ULN in the presence of liver metastasis.
- Renal function: creatinine clearance (CLcr) ≥ 50 mL/min as calculated using the Cockcroft-Gault formula.
- Coagulation function: Prothrombin Time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (or within target range if on anticoagulation therapy).
- Toxicities (other than alopecia) from previous anticancer therapy must have resolved to NCI-CTCAE v5.0 Grade ≤1.
- Women of childbearing potential (WOCBP) must have a serum pregnancy test negative within 7 days before the first dose of GenSci143. WOCBP must agree to use highly effective contraceptive methods and must not donate or retrieve ova for personal use from the time of informed consent until 6 months after the last dose of GenSci143. Male participants must agree to use highly effective contraceptive methods and must not freeze or donate sperm from the time of informed consent until 6 months after the last dose of GenSci143.
Who cannot join
- Participants with known spinal cord compression or active central nervous system (CNS) metastases, unless they are asymptomatic or have achieved post-treatment stability for >4 weeks and discontinued corticosteroids for >2 weeks before the first dose of GenSci143.
- History of other known malignancies within the past 3 years.
- Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose of GenSci143.
- Uncontrolled or clinically significant cardiovascular disease.
- Uncontrolled pleural fluid, pericardial effusion, or ascites requiring drainage, and/or diuretics within 2 weeks before the first dose of GenSci143.
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. Any autoimmune, connective tissue, or inflammatory disorders with suspected pulmonary involvement.
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- Pregnant, breastfeeding, or planning to become pregnant.
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Known human immunodeficiency virus (HIV) infection
- Uncontrolled infection that requires systemic therapy with IV antibiotics, antivirals, or antifungals within 1 week before the first dose of GenSci143.
- Major surgery (excluding diagnostic surgery), radiotherapy, and immunotherapy within 4 weeks before the first dose of medication; Chemotherapy or antibody therapy within 3 weeks; Endocrine therapy and small molecule-targeted therapy within 2 weeks or 5 half-lives(whichever is shorter). Androgen-deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues (either GnRH agonists or GnRH antagonists) was allowed for men with prostate cancer.
- Received any live vaccine within 4 weeks before the first dose of GenSci143 or intend to receive a live vaccine during the study.
- History of allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.
- Prior treatment with an ADC that consists of a topoisomerase inhibitor.
- History of severe hypersensitivity reactions to GenSci143 and/or excipients in the drug product, or other monoclonal antibodies.
- Any illness (uncontrolled hypertension, serious diabetes mellitus, thyroid disorders, and psychiatric disorders, etc.) or other conditions that are not eligible for inclusion based on the investigator's judgment.
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
China9 sites, 9 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310024
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dingwei Ye, +8613701663571, dwyeli@163.com
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
- Recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 451191
United States4 sites, 4 recruiting
- Not yet recruiting
Carolina Biooncology Institute
Huntersville, North Carolina, 28078-3110
- Not yet recruiting
START - Los Angeles - EDOS
Los Angeles, California, 90025
- Not yet recruiting
SCRI OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
- Not yet recruiting
Medical Oncology Associates - Spokane
Spokane, Washington, 99208-1129
About this study
Official title: A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants With Advanced Solid Tumors
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors
Read the detailed description
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Being tested
- GenSci143 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci143 for injectionDrug
GenSci143 for injection, administered Q3W, with a dosage ranging from 0.5mg/kg to 4.5mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| GenSci143 for injection | Experimental | Not described Receives: Drug: GenSci143 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and Part2:Incidence of adverse events Percentage of patients with adverse events by system organ class and preferred term.
Measured: From time of informed consent to 30days post last dose of GenSci143
Part1:Dose limiting toxicities(DLTs),DLTs are assessed during the DLT observation period and defined as any toxicity in DLT definition in the Clinical Study Protocal
Measured: Form time of first dose of GenSci143 to end of DLT observation period(approximately 21 days)
Part1: Maximum tolerated dose (MTD) and recommended dose for expansion (RDE) To determine the maximum tolerated dose (MTD) (if applicable) and recommended dose for expansion (RDE) of GenSci143.
Measured: Form time of first dose of GenSci143 up to 12 months.
Part1: Part2: Composite response rate To evaluate the efficacy of GenSci143 as using RECIST v1.1 and/or PSA50 response (PCWG3) with PC
Measured: Approximately 12 months.
Part1: Part2: Objective response rate(ORR) To evaluate the efficacy of GenSci143 as measured by ORR using RECIST v1.1 for participants with non-PC
Measured: Approximately 12 months.
Secondary outcomes (2)
AUC of GenSci143 Calculate area under the curve of GenSci143.
Measured: Approximately 12 months.
AUC of total antibody Calculate area under the curve of total antibody.
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start20 Dec 2025
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252414
- Sponsor's protocol ID
- GenSci143-101
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07252414
- Acronym / sponsor ID
- GenSci143-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors
Detailed description
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GenSci143 for injection | Experimental | Drug: GenSci143 for injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntarily sign the ICF.
- Male or female participants ≥18 years old at the time of signing the ICF.
- Meet the requirements of tumor types as outlined below:
- Cohort 1: Participants with histologically or cytologically documented mCRPC，who had received at least one prior novel hormonal therapy (including but not limited to abiraterone, enzalutamide, darolutamide, apalutamide) and progressed on standard chemotherapy regimens, are intolerant to chemotherapy, or decline chemotherapy.
- Cohort 2: Participants with histologically or cytologically documented other advanced solid tumors, and who have progressed after standard therapy, are intolerant to standard treatment, or have no standard therapy available.
Key exclusion criteria (16 listed)
- Participants with known spinal cord compression or active central nervous system (CNS) metastases, unless they are asymptomatic or have achieved post-treatment stability for >4 weeks and discontinued corticosteroids for >2 weeks before the first dose of GenSci143.
- History of other known malignancies within the past 3 years.
- Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose of GenSci143.
- Uncontrolled or clinically significant cardiovascular disease.
- Uncontrolled pleural fluid, pericardial effusion, or ascites requiring drainage, and/or diuretics within 2 weeks before the first dose of GenSci143.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenSci143 for injectionGenSci143 for injection, administered Q3W, with a dosage ranging from 0.5mg/kg to 4.5mg/kg. | Drug | GenSci143 for injection |
Primary outcome
Part 1 and Part2:Incidence of adverse events Percentage of patients with adverse events by system organ class and preferred term.
Time frame: From time of informed consent to 30days post last dose of GenSci143
Part1:Dose limiting toxicities(DLTs),DLTs are assessed during the DLT observation period and defined as any toxicity in DLT definition in the Clinical Study Protocal
Time frame: Form time of first dose of GenSci143 to end of DLT observation period(approximately 21 days)
Part1: Maximum tolerated dose (MTD) and recommended dose for expansion (RDE) To determine the maximum tolerated dose (MTD) (if applicable) and recommended dose for expansion (RDE) of GenSci143.
Time frame: Form time of first dose of GenSci143 up to 12 months.
Part1: Part2: Composite response rate To evaluate the efficacy of GenSci143 as using RECIST v1.1 and/or PSA50 response (PCWG3) with PC
Time frame: Approximately 12 months.
Part1: Part2: Objective response rate(ORR) To evaluate the efficacy of GenSci143 as measured by ORR using RECIST v1.1 for participants with non-PC
Time frame: Approximately 12 months.
2 secondary outcomes
AUC of GenSci143 Calculate area under the curve of GenSci143.
Time frame: Approximately 12 months.
AUC of total antibody Calculate area under the curve of total antibody.
Time frame: Approximately 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GenSci143 for injection in people with Advanced Solid Tumors, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dingwei Ye (+86 13701663571, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 and Part2:Incidence of adverse events Percentage of patients with adverse events by system organ class and preferred term. (time frame: From time of informed consent to 30days post last dose of GenSci143). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.