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Advanced Malignant Solid TumorsPhase 1NCT07292402

JSKN022 in Subjects With Advanced Malignant Solid Tumors

A Phase 1 study testing JSKN022 in people with Advanced Malignant Solid Tumors, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if drug JSKN022 is safe to treat patients with advanced malignant solid tumors. It will also learn about the pharmacokinetic/ pharmacodynamic profiles and preliminary antitumor activity of drug JSKN022. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
JSKN022
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
1 siteChina
Study dates
23 Oct 2025to 31 Dec 2027
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 participate and sign the informed consent form.
  • Age ≥ 18 years old, male or female.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • Expected survival ≥ 3 months.
  • Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
  • At least one measurable lesion at baseline according to RECIST 1.1 criteria.
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  • Adequate organ function.
  • Agree to provide Recently archived or fresh tumor tissue samples.
  • Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
  • Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
  • Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
  • Adequate washout period of previous therapy before the first dose.

Who cannot join

  • Complicated with other malignant tumors within 5 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk or tumor types with disease-free survival ≥ 5 years after radical treatment and extremely low recurrence/metastasis risk.
  • History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
  • Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration.
  • Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
  • Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
  • Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
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  • Gastrointestinal abnormalities with obvious clinical manifestations.
  • Active autoimmune diseases requiring systemic treatment within the past two years.
  • Significant serous effusion.
  • Uncontrolled infection.
  • Require regular glucocorticoid or immunosuppressive therapy.
  • Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
  • Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors.
  • Previous occurrence of grade ≥ 3 immune-related adverse events during immunotherapy.
  • Toxicity of previous anti-tumor treatment has not fully or partially recovered.
  • Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
  • Pregnant and/or lactating women, or planning to become pregnant during the study period.
  • Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.
  • Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to high medical risks and/or uncertainty in survival assessment, such as tumor-related leukemia reaction (white blood cell count > 20×10⁹/L), cachexia manifestations, etc.
  • Any other previous or current diseases, treatments, or laboratory test abnormalities that the investigator deems may confuse the study results, affect the patient's full participation in the study, or participation in the study may not be in the best interest of the patient.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ruihua Xu, Dr. contact

086-020-87343468

ruihxu@163.com

China1 site, 1 recruiting
  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruihua Xu, Dr., 086-020-87343468, ruihxu@163.com

    Ruihua Xu, Dr.

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN022 in Subjects With Advanced Malignant Solid Tumors

The goal of this clinical trial is to learn if drug JSKN022 is safe to treat patients with advanced malignant solid tumors. It will also learn about the pharmacokinetic/ pharmacodynamic profiles and preliminary antitumor activity of drug JSKN022.

Read the detailed description

This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK)/pharmacodynamic (PD) profiles, and antitumor activity of JSKN022 in patients with advanced malignant solid tumors.

Patients to be enrolled are with advanced unresectable or metastatic epithelial-derived malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), or be intolerant to standard treatment, or have no access to standard treatment.

The primary objective of the study is to evaluate the safety and tolerability of JSKN022 in patients with advanced malignant solid tumors and to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of JSKN022.

Being tested
JSKN022
Keywords
JSKN022, PD-L1, ITGB6, Antibody-Drug Conjugates

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSKN022Drug

    JSKN022 administered intravenously at selected dose levels according to protocol

Study groups in NCT07292402
Study groupRoleWhat they receive
Dose escalation cohorts 1ExperimentalNot described
Receives: Drug: JSKN022
Dose escalation cohort 2ExperimentalNot described
Receives: Drug: JSKN022
Dose escalation cohort 3ExperimentalNot described
Receives: Drug: JSKN022
Dose escalation cohort 4ExperimentalNot described
Receives: Drug: JSKN022
Dose escalation cohort 5ExperimentalNot described
Receives: Drug: JSKN022
Dose escalation cohort 6ExperimentalNot described
Receives: Drug: JSKN022
Dose escalation cohort 7ExperimentalNot described
Receives: Drug: JSKN022
Dose escalation cohort 8ExperimentalNot described
Receives: Drug: JSKN022
Dose optimization cohort in selected tumor type 1ExperimentalNot described
Receives: Drug: JSKN022
Dose optimization cohort in selected tumor type 2ExperimentalNot described
Receives: Drug: JSKN022
Dose optimization cohort 3 - other advanced epithelial malignant tumors cohortExperimentalNot described
Receives: Drug: JSKN022

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN-022).

    Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc.; abnormalities in physical examinations, laboratory tests, electrocardiograms, and other safety assessments.

    Measured: From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.

  2. Incidence of dose-limiting toxicity (DLT) in each dose group

    Measured: 21 days from the first dose

  3. Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of JSKN022.

    Measured: Up to 24 months

Secondary outcomes (14)
  1. Objective response rate (ORR)

    The proportion of subjects who achieve confirmed complete response (CR) or partial response (PR) as assessed by RECIST v1.1. ORR analysis will be based on the EAS set, with the proportion of subjects achieving objective response and the Clopper-Pearson exact 95% CI calculated.

    Measured: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.

  2. Duration of response (DoR)

    Defined as the time from the first documented evidence of response (PR or CR) to the first documented evidence of progressive disease (PD) or death from any cause in subjects with confirmed response (RECIST v1.1, PR or CR). For subjects without documented progression or death, DoR will be censored at the time of the last adequate tumor assessment. DoR analysis will be performed on subjects achieving CR or PR, with the median duration of response and 95% CI estimated using the Kaplan-Meier method.

    Measured: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed up to 24 months.

  3. Disease control rate (DCR)

    The proportion of subjects who achieve confirmed CR, PR, or SD as assessed by RECIST v1.1. DCR analysis will be based on the EAS set, with the proportion of subjects achieving disease control and the Clopper-Pearson exact 95% CI calculated.

    Measured: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.

  4. Clinical benefit rate (CBR)

    The proportion of subjects who achieve confirmed CR, PR, or stable disease (SD) lasting more than 6 months as assessed by RECIST v1.1. CBR analysis will be based on the EAS set, with the proportion of subjects achieving clinical benefit and the Clopper-Pearson exact 95% CI calculated.

    Measured: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.

  5. Progression-Free Survival (PFS)

    Defined as the time from the first administration of the study drug to the first documentation of PD or death from any cause. PFS analysis will be based on the SAS set, with the median progression-free survival and 95% CI estimated using the Kaplan-Meier method. The 3-month, 6-month, 9-month, and 12-month progression-free survival rates and their 95% CIs will be calculated, and progression-free survival curves will be plotted.

    Measured: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed up to 24 months.

  6. 6-Month and 12-Month Overall Survival Rates

    Defined as the probability of survival 6 months and 12 months after the first administration of the study drug, respectively. Analysis of 12-month survival rate will be based on the SAS set, with the 12-month survival rate and 95% CI estimated using the Kaplan-Meier method.

    Measured: From the first administration of the study drug until the death. Assessed up to 24 months.

  7. Incidence of anti-drug antibodies (ADA), antibody titers, and incidence of neutralizing antibodies (Nab, if applicable).

    Measured: Up to 24 months

  8. Maximum concentration (Cmax) of JSKN022

    Maximum concentration (Cmax) of JSKN022

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  9. Time to maximum concentration (Tmax) of JSKN022

    Time to maximum concentration (Tmax) of JSKN022

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  10. Trough concentration (Ctrough) of JSKN022

    Trough concentration (Ctrough) of JSKN022

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  11. Area under the concentration-time curve of JSKN022

    Area under the concentration-time curve of JSKN022

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  12. Volume of distribution (V) of JSKN022

    Volume of distribution (V) of JSKN022

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  13. Elimination half-life (t1/2) of JSKN022

    Elimination half-life (t1/2) of JSKN022

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  14. Clearance (CL) of JSKN022

    Clearance (CL) of JSKN022

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start23 Oct 2025
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07292402
Sponsor's protocol ID
JSKN022-101
Status last verified
Dec 2025
First submitted
13 Nov 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JSKN022 in people with Advanced Malignant Solid Tumors, run by Jiangsu Alphamab Biopharmaceuticals 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 12 inclusion and 20 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 23 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 Ruihua Xu, Dr. (086-020-87343468, ruihxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN-022). (time frame: From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.). 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 23 Dec 2025.

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