Advanced Solid TumorsPhase 1NCT07251166
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of GenSci140 in Participants With Advanced Solid Tumors
A Phase 1 study testing GenSci140 for Injection in people with Advanced Solid Tumors, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a phase I, multi-center, open-label, dose-escalation (Part 1) and dose-expansion (Part 2) first-in-human study in China to evaluate the safety, tolerability, PK profile and efficacy of GenSci140 in participants with advanced solid tumors, and to determine the MTD (if any) and RDE. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- GenSci140 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are able to understand and willing to sign written Informed Consent Form.
- Aged between 18 and 75 years (inclusive) when signing the ICF
- Participants with advanced solid tumors
- The participant agrees to provide fresh biopsy or archived tumor tissues for testing by the central laboratory.
- At least one evaluable lesion in the dose-escalation part, and at least one measurable lesion in the dose-expansion part.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
Show all 14Show fewer
- Life expectancy ≥ 3 months.
- Adequate hematologic and organ function before the first dose of GenSci140.
- All toxicities related to prior anti-tumor therapies must have resolved to Grade ≤ 1, with the following exceptions: alopecia, peripheral neurotoxicity (must have resolved to Grade ≤ 2).
- For participants with congestive heart failure (CHF), it must be Grade ≤ 1 in severity and must have recovered completely prior to enrollment.
- Normal QT interval on electrocardiogram (ECG) evaluation at screening
- Participants who test negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result. WOCBP must agree to avoid pregnancy.
- Men with female partners of childbearing potential must take appropriate precautions to avoid pregnancy of partner and use appropriate barrier contraceptives or abstinence
Who cannot join
- Past history of cancers.
- Symptomatic primary central nervous system (CNS) tumors, metastases, leptomeningeal carcinomatosis, or therapy naive spinal cord compression.
- Use of an investigational medicinal product (IMP) or antitumor therapy (including chemotherapy, biologic therapy, immunotherapy) within 5 half-lives or 4 weeks before the first dose of GenSci140. Concomitant anti-tumor therapy is not permitted
- Major surgery within 4 weeks prior to the first dose of GenSci140.
- Radiotherapy for ≥ 20% of bone marrow or large area of radiotherapy within 4 weeks prior to the first dose of GenSci140. Or participants have not recovered from acute effects of radiotherapy to baseline prior to the first dose of GenSci140.
- Clinically significant active cardiovascular disorder or history of myocardial infarction within 6 months prior to the first dose of GenSci140.
Show all 14Show fewer
- Uncontrolled active systemic bacterial, viral, or fungal infection or ongoing serious systemic disease, such as hypertension or diabetes, despite Best Supportive Care. Chronic disease screening is not required.
- History of multiple sclerosis or other demyelinating diseases, Eaton-Lambert syndrome (paraneoplastic syndrome), alcoholic liver disease, history of internal haemorrhage or ischemic stroke within the past 6 months, haemorrhagic diathesis that are unsuitable for enrollment as assessed by the investigator.
- Suspected treatment-related pneumonitis that was clinically diagnosed in the past and currently requires steroids or cannot be ruled out by imaging at screening.
- Uncontrolled pleural effusion, pericardial effusion, or abdominal and pelvic fluid collection requiring drainage and/or diuretics within 14 days prior to the first dose of GenSci140.
- Pregnant or lactating women.
- Known hypersensitivity to prior monoclonal antibody therapy.
- Patients who previously underwent allogeneic or autologous bone marrow transplantation.
- Participants whom the investigator deems unsuitable for enrollment in this clinical study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Lingying Wu, Doctor, +8613910865483, wulingying@csco.org.cn
About this study
Official title: A Multi-center, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Efficacy of GenSci140 in Patients With Advanced Solid Tumors
This is a phase I, multi-center, open-label, dose-escalation (Part 1) and dose-expansion (Part 2) first-in-human study in China to evaluate the safety, tolerability, PK profile and efficacy of GenSci140 in participants with advanced solid tumors, and to determine the MTD (if any) and RDE. The dose-expansion study aims to evaluate the efficacy, safety and PK profile of GenSci140 in the treatment of ovarian cancer or other FRα-positive advanced solid tumors at different dose levels, and to select an appropriate RP2D (if applicable).
- Conditions
- Advanced Solid Tumors
- Being tested
- GenSci140 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci140 for InjectionDrug
Participants will receive GenSci140 on Day 1 of each 21-day cycle. GenSci140 will be administered until unacceptable toxicity, disease progression, withdrawal of informed consent, death, loss to follow-up, or initiation of new anti-tumor therapy (whichever occurs first).
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1~ Dose Level 5 | Experimental | Participants who meet the inclusion criteria and do not meet the exclusion criteria will be sequentially enrolled into five pre-specified doses for dose groups 1-5. Receives: Drug: GenSci140 for Injection |
| Cohort 1~ Cohort 4 | Experimental | Cohort 1: Cohort 1 is planned to be conducted in patients with ovarian cancer. Cohort 2: FRα-positive endometrial cancer. Cohort 3: FRα-positive lung cancer. Cohort 4: FRα-positive triple negative breast cancer. Receives: Drug: GenSci140 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse event (AEs), and incidence of dose limiting toxicities（DLTs）
To determine the MTD (if any) of GenSci140 in participants with advanced solid tumors
Measured: 3 weeks
maximal tolerance dose （MTD）
To determine the MTD (if any) of GenSci140 in participants with advanced solid tumors
Measured: up to 3 months
recommended dose of expansion （RDE）
To determine the RDE of GenSci140 in participants with advanced solid tumors
Measured: up to 3 months
objective response rate（ORR）
To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors
Measured: up to 5 months
duration of response（DOR）
To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors
Measured: up to 5 months
disease control rate（DCR）
To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors
Measured: up to 5 months
Incidence and severity of adverse event (AEs)
To evaluate the safety and tolerability of GenSci140 at specific doses in participants with specific advanced solid tumors.
Measured: up to 5 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 start10 Dec 2025
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 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
- NCT07251166
- Sponsor's protocol ID
- GenSci140-101
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Efficacy of GenSci140 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07251166
- Acronym / sponsor ID
- GenSci140-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (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.
This is a phase I, multi-center, open-label, dose-escalation (Part 1) and dose-expansion (Part 2) first-in-human study in China to evaluate the safety, tolerability, PK profile and efficacy of GenSci140 in participants with advanced solid tumors, and to determine the MTD (if any) and RDE. The dose-expansion study aims to evaluate the efficacy, safety and PK profile of GenSci140 in the treatment of ovarian cancer or other FRα-positive advanced solid tumors at different dose levels, and to select an appropriate RP2D (if applicable).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1~ Dose Level 5 | Experimental | Drug: GenSci140 for InjectionParticipants who meet the inclusion criteria and do not meet the exclusion criteria will be sequentially enrolled into five pre-specified doses for dose groups 1-5. |
| Cohort 1~ Cohort 4 | Experimental | Drug: GenSci140 for InjectionCohort 1: Cohort 1 is planned to be conducted in patients with ovarian cancer. Cohort 2: FRα-positive endometrial cancer. Cohort 3: FRα-positive lung cancer. Cohort 4: FRα-positive triple negative breast cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Those who are able to understand and willing to sign written Informed Consent Form.
- Aged between 18 and 75 years (inclusive) when signing the ICF
- Participants with advanced solid tumors
- The participant agrees to provide fresh biopsy or archived tumor tissues for testing by the central laboratory.
- At least one evaluable lesion in the dose-escalation part, and at least one measurable lesion in the dose-expansion part.
Key exclusion criteria (14 listed)
- Past history of cancers.
- Symptomatic primary central nervous system (CNS) tumors, metastases, leptomeningeal carcinomatosis, or therapy naive spinal cord compression.
- Use of an investigational medicinal product (IMP) or antitumor therapy (including chemotherapy, biologic therapy, immunotherapy) within 5 half-lives or 4 weeks before the first dose of GenSci140. Concomitant anti-tumor therapy is not permitted
- Major surgery within 4 weeks prior to the first dose of GenSci140.
- Radiotherapy for ≥ 20% of bone marrow or large area of radiotherapy within 4 weeks prior to the first dose of GenSci140. Or participants have not recovered from acute effects of radiotherapy to baseline prior to the first dose of GenSci140.
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 |
|---|---|---|
| GenSci140 for InjectionParticipants will receive GenSci140 on Day 1 of each 21-day cycle. GenSci140 will be administered until unacceptable toxicity, disease progression, withdrawal of informed consent, death, loss to follow-up, or initiation of new anti-tumor therapy (whichever occurs first). | Drug | Cohort 1~ Cohort 4, Dose Level 1~ Dose Level 5 |
Primary outcome
Incidence and severity of adverse event (AEs), and incidence of dose limiting toxicities（DLTs）
Time frame: 3 weeks
To determine the MTD (if any) of GenSci140 in participants with advanced solid tumors
maximal tolerance dose （MTD）
Time frame: up to 3 months
To determine the MTD (if any) of GenSci140 in participants with advanced solid tumors
recommended dose of expansion （RDE）
Time frame: up to 3 months
To determine the RDE of GenSci140 in participants with advanced solid tumors
objective response rate（ORR）
Time frame: up to 5 months
To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors
duration of response（DOR）
Time frame: up to 5 months
To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors
disease control rate（DCR）
Time frame: up to 5 months
To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors
Incidence and severity of adverse event (AEs)
Time frame: up to 5 months
To evaluate the safety and tolerability of GenSci140 at specific doses in participants with specific advanced solid tumors.
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 24 Dec 2025.
Related trials for Advanced Solid Tumors
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GenSci140 for Injection in people with Advanced Solid Tumors, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
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 14 inclusion and 14 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Wen Xu (+8618861095711, xuwen01@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse event (AEs), and incidence of dose limiting toxicities（DLTs） (time frame: 3 weeks). The study lists 7 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 24 Dec 2025.