Advanced Solid TumorPhase 1/2NCT06226766
JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors
A Phase 1/2 study testing JSKN033 Injection in people with Advanced Solid Tumor, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in Australia.
Trial summary
This study is an open-label, multicenter, first-in-human, Phase I/II (dose escalation and dose expansion) study to evaluate the safety, tolerability, PK, immunogenicity and efficacy of JSKN033 in patients with advanced unresectable or metastatic solid malignant tumors that are expected to be HER2 expression (IHC ≥ 1+). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- JSKN033 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Jan 2024to 31 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 willing and able to provide written informed consent form (ICF) for the trial.
- Male or female, 18 years of age or older; willing and able to complete all required procedures of study.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, and life expectancy ≥ 12 weeks.
- Must have a pathologically documented advanced unresectable or metastatic solid malignant tumor (gastrointestinal tumor for dose expansion phase) with HER2 expression (IHC ≥1+) that is refractory to or intolerable with standard treatment, or for which no effective standard treatment is available. HER2 mutation in patients with NSCLC is also regarded as HER2 expression.
- Baseline measurable disease according to RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Adequate organ function assessed within 7 days prior to first trial treatment [had not received blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF) or other relevant medical support within 14 days before the administration of the investigational product].
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- Have adequate treatment washout period before first dose.
- Have LVEF ≥50% by either echo cardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days prior to first dose.
- Female or male patients of childbearing potential should be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 180 days after completion of study treatment. Female of childbearing potential should have a negative pregnancy test within 7 days prior to first trial treatment (childbearing potential is defined as premenopausal females without documented tubal ligation or hysterectomy, or postmenopausal females within 1 year).
Who cannot join
- Patients with untreated active brain metastases or meningeal or spinal cord metastases are excluded. If the subject has received treatment for brain metastases and the metastases are stable (as evidenced by brain imaging within 28 days prior to study treatment showing stable disease, no new lesions, and no new neurological symptoms, and no requirement for steroids for at least 14 days prior to study treatment), they may be eligible for enrollment.
- Concurrent malignancy within 5 years prior to first dose other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer, thyroid cancer not requiring treatment, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.
- Prior treatment with an antibody-drug conjugate (ADC) which consists of a topoisomerase I inhibitor derivative.
- History of uncontrolled concurrent illness.
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by image at screening.
- Previous severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection either suspected or confirmed within 4 weeks prior to screening. Acute symptoms will be excluded, or must have resolved and based on investigator assessment, there are no sequela that would place participant at a higher risk of receiving investigational treatment.
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- Patients with ascites, pleural effusion, pericardial effusion which cannot be controlled by appropriate interventions.
- Have unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, grade 2 hypoparathyroidism) related to prior anticancer therapy and stable anemia not yet resolved to grade ≤ 1 (NCI-CTCAEV5.0).
- Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. A brief course of corticosteroids for the prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
- History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or excipients in JSKN033 drug formulation.
- Prior history of anti-HER2 therapy induced angioedema, or severe hypotension and Severe allergic reactions to other antibody drugs or topoisomerase I inhibitors.
- Other conditions that, in the investigators' opinion, would make patients inappropriate to participate in this study, such as a history of mental illness, alcoholism or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors
This study is an open-label, multicenter, first-in-human, Phase I/II (dose escalation and dose expansion) study to evaluate the safety, tolerability, PK, immunogenicity and efficacy of JSKN033 in patients with advanced unresectable or metastatic solid malignant tumors that are expected to be HER2 expression (IHC ≥ 1+).
Read the detailed description
This study is an open label, multicenter, first in human, Phase I/II (dose escalation and dose expansion) study to evaluate the safety, tolerability, PK, immunogenicity and efficacy of JSKN033 in patients with advanced unresectable or metastatic solid malignant tumors that are expected to be HER2 expression.
JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection.
Phase I will be a dose escalation phase - Participants will be enrolled to receive 1.1 mg/kg , 2.3 mg/kg, 4.5 mg/kg, 5.6 mg/kg or 6.7 mg/kg, once a week.
Phase II will be a dose expansion phase - After/during dose escalation, SMC will select 1-2 dose levels to expand with additional patients with gastrointestinal tumor with HER2 expression each dose level for further exploration of the efficacy and safety of JSKN033. Once treatment is discontinued, participants will be followed up every 12 weeks for any AEs and alternative anti-cancer treatment.
- Conditions
- Advanced Solid Tumor
- Being tested
- JSKN033 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN033 InjectionDrug
JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation/expansion | Experimental | The dose escalation phase will utilize single patient accelerated dose titration (ADT) for dose level 1 (1.1 mg/kg , SC, QW) and dose level 2 (2.3 mg/kg, SC, QW), followed by dose level 3 (4.5 mg/kg, SC, QW), dose level 4 (5.6 mg/kg, SC, QW) and dose level 5 (6.7 mg/kg, SC,QW), which will all be enrolled and monitored using the "3+3" design, aimed at determining the MTD/RP2D of JSKN033.
After or during dose escalation, SMC will select 1-2 dose levels to expand with 10-30 additional patients with gastrointestinal tumor with HER2 expression each dose level for further exploration of the efficacy and safety of JSKN033. Receives: Drug: JSKN033 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), assessed by CTCAE V5.0
Clinically significant changes in physical examination findings, vital sign measurements, standard clinical laboratory parameters, 12-lead electrocardiogram (ECG) parameters, ECHO cardiography or multiple-gated acquisition (MUGA) scan findings will be recorded as AEs.
Measured: Postdose of last participant up to 1 year
RP2D( recommend Phase II dose)
To determine RP2D of JSKN033
Measured: Postdose of last participant up to 1 year
DLTs （Dose-limiting toxicities）
DLTs are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Measured: Baseline up to 21 days after the first dose
Objective Response Rate (ORR) Following Treatment With JSKN033 in Participants With Advanced Solid Malignant Tumors
Objective response rate (ORR) by investigators' review was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: From 6 weeks postdose of last participant up to 1 years
Secondary outcomes (6)
Maximum concentration (Cmax)
Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab
Measured: Postdose of last participant up to 1 year
Time at which Cmax is reached (Tmax)
Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab
Measured: Postdose of last participant up to 1 year
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: Postdose of last participant up to 1 year
Progression-Free Survival (PFS) Following Treatment With JSKN033 in Participants
PFS by investigator assessment is defined as the time from first dose of study drug to disease progression(as per RECIST v1.1) or death
Measured: Postdose of last participant up to 1 year
Duration of Response (DoR) Following Treatment With JSKN033 in Participants
DOR is defined as the time from assessment of complete response or partial response to disease progression or death in patients who achieve complete or partial response.
Measured: Postdose of last participant up to 1 year
Overall Survival (OS) Following Treatment With JSKN033 in Participants
OS is defined as the time from first dose of study drug to death due to any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.
Measured: Postdose of last participant up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start18 Jan 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Why it stopped: the decision is based on a strategic realignment of our clinical trial priorities to optimize the overall development pathway for JSKN033
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlotte Lemech, Principal investigator, Scientia Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226766
- Sponsor's protocol ID
- JSKN033-101
- Status last verified
- Sep 2025
- First submitted
- 22 Dec 2023
- Last updated
- 10 Sep 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors
- ClinicalTrials.gov ID
- NCT06226766
- Acronym / sponsor ID
- JSKN033-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the decision is based on a strategic realignment of our clinical trial priorities to optimize the overall development pathway for JSKN033
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 26 Jan 2024 (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 study is an open-label, multicenter, first-in-human, Phase I/II (dose escalation and dose expansion) study to evaluate the safety, tolerability, PK, immunogenicity and efficacy of JSKN033 in patients with advanced unresectable or metastatic solid malignant tumors that are expected to be HER2 expression (IHC ≥ 1+).
Detailed description
This study is an open label, multicenter, first in human, Phase I/II (dose escalation and dose expansion) study to evaluate the safety, tolerability, PK, immunogenicity and efficacy of JSKN033 in patients with advanced unresectable or metastatic solid malignant tumors that are expected to be HER2 expression.
JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection.
Phase I will be a dose escalation phase - Participants will be enrolled to receive 1.1 mg/kg , 2.3 mg/kg, 4.5 mg/kg, 5.6 mg/kg or 6.7 mg/kg, once a week.
Phase II will be a dose expansion phase - After/during dose escalation, SMC will select 1-2 dose levels to expand with additional patients with gastrointestinal tumor with HER2 expression each dose level for further exploration of the efficacy and safety of JSKN033. Once treatment is discontinued, participants will be followed up every 12 weeks for any AEs and alternative anti-cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| Dose escalation/expansion | Experimental | Drug: JSKN033 InjectionThe dose escalation phase will utilize single patient accelerated dose titration (ADT) for dose level 1 (1.1 mg/kg , SC, QW) and dose level 2 (2.3 mg/kg, SC, QW), followed by dose level 3 (4.5 mg/kg, SC, QW), dose level 4 (5.6 mg/kg, SC, QW) and dose level 5 (6.7 mg/kg, SC,QW), which will all be enrolled and monitored using the "3+3" design, aimed at determining the MTD/RP2D of JSKN033. After or during dose escalation, SMC will select 1-2 dose levels to expand with 10-30 additional patients with gastrointestinal tumor with HER2 expression each dose level for further exploration of the efficacy and safety of JSKN033. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be willing and able to provide written informed consent form (ICF) for the trial.
- Male or female, 18 years of age or older; willing and able to complete all required procedures of study.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, and life expectancy ≥ 12 weeks.
- Must have a pathologically documented advanced unresectable or metastatic solid malignant tumor (gastrointestinal tumor for dose expansion phase) with HER2 expression (IHC ≥1+) that is refractory to or intolerable with standard treatment, or for which no effective standard treatment is available. HER2 mutation in patients with NSCLC is also regarded as HER2 expression.
- Baseline measurable disease according to RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Key exclusion criteria (12 listed)
- Patients with untreated active brain metastases or meningeal or spinal cord metastases are excluded. If the subject has received treatment for brain metastases and the metastases are stable (as evidenced by brain imaging within 28 days prior to study treatment showing stable disease, no new lesions, and no new neurological symptoms, and no requirement for steroids for at least 14 days prior to study treatment), they may be eligible for enrollment.
- Concurrent malignancy within 5 years prior to first dose other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer, thyroid cancer not requiring treatment, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.
- Prior treatment with an antibody-drug conjugate (ADC) which consists of a topoisomerase I inhibitor derivative.
- History of uncontrolled concurrent illness.
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by image at screening.
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 |
|---|---|---|
| JSKN033 InjectionJSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection. | Drug | Dose escalation/expansion |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), assessed by CTCAE V5.0
Time frame: Postdose of last participant up to 1 year
Clinically significant changes in physical examination findings, vital sign measurements, standard clinical laboratory parameters, 12-lead electrocardiogram (ECG) parameters, ECHO cardiography or multiple-gated acquisition (MUGA) scan findings will be recorded as AEs.
RP2D( recommend Phase II dose)
Time frame: Postdose of last participant up to 1 year
To determine RP2D of JSKN033
DLTs （Dose-limiting toxicities）
Time frame: Baseline up to 21 days after the first dose
DLTs are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Objective Response Rate (ORR) Following Treatment With JSKN033 in Participants With Advanced Solid Malignant Tumors
Time frame: From 6 weeks postdose of last participant up to 1 years
Objective response rate (ORR) by investigators' review was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
6 secondary outcomes
Maximum concentration (Cmax)
Time frame: Postdose of last participant up to 1 year
Time at which Cmax is reached (Tmax)
Time frame: Postdose of last participant up to 1 year
Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)
Time frame: Postdose of last participant up to 1 year
Progression-Free Survival (PFS) Following Treatment With JSKN033 in Participants
Time frame: Postdose of last participant up to 1 year
Duration of Response (DoR) Following Treatment With JSKN033 in Participants
Time frame: Postdose of last participant up to 1 year
Overall Survival (OS) Following Treatment With JSKN033 in Participants
Time frame: Postdose of last participant up to 1 year
Results and safety
The study was stopped early (reason given: the decision is based on a strategic realignment of our clinical trial priorities to optimize the overall development pathway for JSKN033). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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. This study is not recruiting at the moment.
Charlotte Lemech principal investigator
Scientia Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JSKN033 Injection in people with Advanced Solid Tumor, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in Australia.
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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Sep 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 Australia. 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 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?
The study was stopped early (reason given: the decision is based on a strategic realignment of our clinical trial priorities to optimize the overall development pathway for JSKN033). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), assessed by CTCAE V5.0 (time frame: Postdose of last participant up to 1 year). The study lists 4 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 10 Sep 2025.