Advanced Malignant TumorsPhase 1/2NCT06770881
JSKN033 in Chinese Subjects with Advanced Malignant Tumors
A Phase 1/2 study testing JSKN033 in people with Advanced Malignant Tumors, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
Trial summary
This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- JSKN033
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 31 Dec 2027
- Phase
- Phase 1/2
- 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
- Be able to understand informed consent form, voluntarily participate and sign informed consent form.
- Age ≥18 year (at the time consent is obtained), male or female.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Has a Life expectancy ≥3 months.
- Has a pathologically documented advanced/unresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.
- Has at least 1 measurable lesion at baseline according to RECIST 1.1 criteria.
- Must have adequate organ function prior to the start of JSKN033.
- Negative urine/serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.
Who cannot join
- Has clinically active brain metastases.
- Previously received any other investigational drug within 28 days prior to enrollment.
- Previously received local palliative treatment within 14 days prior to enrollment.
- Previously received major surgeries within 28 days prior to enrollment.
- Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.
- Previously received live vaccine within 28 days prior to enrollment.
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- Previously received antibody conjugate drug with topoisomerase I inhibitor.
- Has a history of other primary malignant tumors within 5 years prior to enrollment.
- Has uncontrolled comorbidities as specified by the protocol.
- Has a history of interstitial pneumonia/lung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia/lung disease that cannot be ruled out by imaging during screening period.
- Subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc.
- Toxicities of previous antitumor therapy did not resolve to grade 1 defined by CTCAE v5.0.
- Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug.
- Has a history of allogeneic bone marrow or organ transplantation.
- Pregnant or breastfeeding female patients.
- Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN033 in Chinese Subjects with Advanced Malignant Tumors
This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.
- Conditions
- Advanced Malignant Tumors
- Being tested
- JSKN033
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN033Drug
JSKN033 should be administered subcutaneously on the first day of each week cycle/ each 2-week cycle
| Study group | Role | What they receive |
|---|---|---|
| JSKN033 | Experimental | Not described Receives: Drug: JSKN033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Incidence of DLT in the dose escalation period.
Measured: Up to 12 months
Maximum Tolerated Dose (MTD) or recommend Phase II dose (RP2D).
Based on safety and efficacy data.
Measured: Up to 12 months
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAE) and Treatment Related Adverse Events (TRAE)
TEAE and TRAE were graded according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Measured: Throughout the duration of the study, approximately 2 years
Secondary outcomes (7)
Anti-drug antibodies (ADA) and neutralizing antibodies
Status (positive or negative) and serum titers of anti-JSKN033 antibody.
Measured: Throughout the duration of the study, about 2 years
Objective response rate (ORR)
ORR is determined by investigators based on RECIST 1.1 criteria.
Measured: Throughout the duration of the study, about 2 years
Disease control rate (DCR)
DCR is determined by investigators based on RECIST 1.1 criteria.
Measured: Throughout the duration of the study, about 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic disease progression or death due to any cause.
Measured: Throughout the duration of the study, about 2 years
Maximum concentration (Cmax)
Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab.
Measured: Throughout the duration of the study, about 2 years
Time at which Cmax is reached (Tmax)
Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab.
Measured: Throughout the duration of the study, about 2 years
Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)
Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab.
Measured: Throughout the duration of the study, about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Jiangsu Alphamab Biopharmaceuticals Co., LtdThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- XiaoHua Wu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770881
- Sponsor's protocol ID
- JSKN033-102
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN033 in Chinese Subjects with Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT06770881
- Acronym / sponsor ID
- JSKN033-102
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 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/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JSKN033 | Experimental | Drug: JSKN033 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be able to understand informed consent form, voluntarily participate and sign informed consent form.
- Age ≥18 year (at the time consent is obtained), male or female.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Has a Life expectancy ≥3 months.
- Has a pathologically documented advanced/unresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.
Key exclusion criteria (16 listed)
- Has clinically active brain metastases.
- Previously received any other investigational drug within 28 days prior to enrollment.
- Previously received local palliative treatment within 14 days prior to enrollment.
- Previously received major surgeries within 28 days prior to enrollment.
- Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.
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 |
|---|---|---|
| JSKN033JSKN033 should be administered subcutaneously on the first day of each week cycle/ each 2-week cycle | Drug | JSKN033 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Up to 12 months
Incidence of DLT in the dose escalation period.
Maximum Tolerated Dose (MTD) or recommend Phase II dose (RP2D).
Time frame: Up to 12 months
Based on safety and efficacy data.
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAE) and Treatment Related Adverse Events (TRAE)
Time frame: Throughout the duration of the study, approximately 2 years
TEAE and TRAE were graded according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
7 secondary outcomes
Anti-drug antibodies (ADA) and neutralizing antibodies
Time frame: Throughout the duration of the study, about 2 years
Objective response rate (ORR)
Time frame: Throughout the duration of the study, about 2 years
Disease control rate (DCR)
Time frame: Throughout the duration of the study, about 2 years
Progression-free survival (PFS)
Time frame: Throughout the duration of the study, about 2 years
Maximum concentration (Cmax)
Time frame: Throughout the duration of the study, about 2 years
Time at which Cmax is reached (Tmax)
Time frame: Throughout the duration of the study, about 2 years
Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)
Time frame: Throughout the duration of the study, about 2 years
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 13 Jan 2025.
- Individual participant dataSharing planned: No
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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.
XiaoHua Wu, MD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JSKN033 in people with Advanced Malignant Tumors, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
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 8 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: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 XiaoHua Wu, MD (02134778299, wu.xh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Up to 12 months). The study lists 3 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 13 Jan 2025.