Advanced Solid TumorsPhase 1NCT05494918
First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors
A Phase 1 study testing JSKN003 in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Alphamab (Australia) Co Pty Ltd. at 1 site in Australia.
Trial summary
This study is an open-label, multicenter, first-in-human, Phase I, dose escalation study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of JSKN003 in subjects with advanced inoperable or metastatic solid malignant tumors that are expected to be HER2 expression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- JSKN003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Sep 2022to 15 Apr 2025
- Phase
- Phase 1
- 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 signed informed consent form (ICF) for the trial.
- Male or female, 18 years of age or older; willing and able to comply with study requirements.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 with no deterioration within 2 weeks of scheduled study treatment, and life expectancy ≥ 12 weeks.
- Must have a pathologically documented advanced/unresectable or metastatic solid malignant tumor with HER-2 expression (IHC ≥ 1+) that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- 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 trial treatment.
- Have LVEF ≥ 50% by either echo cardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days prior to first trial treatment.
- Female or male subjects 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 the trial 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
- Clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, with following exceptions:
- Clinically stable through MRI/CT scans (at least 2 consecutive scans within prior 6 months including 1 scan within 28 days prior to screening) and no progressive or uncontrolled neurologic symptoms or signs (e.g., seizures, headaches, central nausea/emesis, progressive neurologic deficits, papilledema) for at least 4 weeks prior to the first treatment.
- Any untreated asymptomatic brain metastases not requiring immediate local or systemic therapy (e.g., mannitol or corticosteroids).
- Leptomeningeal metastasis is excluded from the study entry.
- Concurrent malignancy within 5 years prior to entry 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.
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- History of uncontrolled intercurrent illness including but not limited to:
- Active HBV or HCV infection. If HBsAg and HCV antibody positive, HBV DNA and HCV RNA assay should be performed. Subjects are eligible if HBV DNA ≤ 500 UI/ml (or 2000 copies/ml) or HCV RNA negative.
- Known HIV infection or known history of acquired immune deficiency syndrome (AIDS);
- Active tuberculosis infection.
- Active infection within 4 weeks prior to the first dose of trial treatment that require the use of systemic antibiotics ≥ 7 days.
- Hypertension uncontrolled by standard therapies (not stabilized to 160/100 mmHg);
- Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina pectoris (< 6 months prior to enrolment), congestive heart failure (New York Heart Association Classification Class II-IV) or serious cardiac arrhythmia requiring medication (including corrected QT interval prolongation of > 470 msec for women and > 450 for men calculated according to Fridericia and/or pacemaker or prior diagnosis of congenital long QT syndrome;
- Serious nonhealing wound, ulcer or bone fracture.
- 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.
- Subjects 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 (i.e., untransfused Hb ≥ 9 g/dL without the need for supportive transfusion within 2 weeks of screening) not yet resolved to grade ≤ 1 (NCI-CTCAEV5.0).
- Subjects 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 JSKN003 drug formulation.
- Prior history of Herceptin induced anaphylaxis, angioedema, or severe hypotension.
- Other conditions that, in the investigators' opinion, would make subjects 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.
Australia1 site
Breast Cancer Research Centre
Perth, Western Australia, 6009
About this study
Official title: A Phase I, Multi-center, Open-label, Dose Escalation, First-In-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of JSKN003 in Subjects With Advanced or Metastatic Solid Malignant Tumors
This study is an open-label, multicenter, first-in-human, Phase I, dose escalation study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of JSKN003 in subjects with advanced inoperable or metastatic solid malignant tumors that are expected to be HER2 expression.
Read the detailed description
The dose escalation study will utilize single patient accelerated dose titration for the first two dose levels, 1.0 and 2.1 mg/kg, followed by dose cohorts 4.2, 5.2, 6.3, 7.3, and 8.4 mg/kg which will all be enrolled and monitored using the Bayesian optimal interval design, aimed at determining the MTD, RDE/RP2D of JSKN003. The dose-escalation of 9.4 mg/kg and 10.5 mg/kg should be determined per discussion between Safety Monitoring Committee and sponsor if deemed necessary, the SMC had the right of deciding to dose-escalate at other dose levels . Moreover, the SMC is also responsible for deciding the MTD and the recommended dose level for dose-expansion study.
Enrolled patients will be sequentially assigned to the planned dose levels as required by the protocol and treated with JSKN003 IV Q3W to observe the occurrence of treatment related AEs and dose limiting toxicities. The DLT observation period is 21 days from administration of the first dose of JSKN003.
The study will use a modified ADT design and BOIN design for dosing cohort management to determine the MTD and RDE/RP2D. The starting dose of JSKN003 is 1.0 mg/kg, followed by 2.1, 4.2, 5.3, 6.3, 7.3, 8.4, 9.4 and 10.5 mg/kg. The investigational product will be administered on Day 1 every 3 weeks via intravenous infusion, and the first cycle of JSKN003 treatment is for DLT evaluation.
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Being tested
- JSKN003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN003Drug
Also called anti-Her2 ADC JSKN003
JSKN003 is to be administered via intravenous (IV) dose
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | It's a dose escalation to identify the Maximum Tolerated dose (MTD) , recommended dose for expansion (RDE) or recommended Phase II dose (RP2D) of JSKN003, guided by the modified ADT design and BOIN design. Receives: Drug: JSKN003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Maximum tolerated dose
Measured: Postdose of last participant up to 1 year
Preliminary RDE/RP2D
recommended dose for expansion / recommended phase 2 dose
Measured: Postdose of last participant up to 1 year
DLTs
Dose Limiting Toxicities
Measured: Baseline up to 21 days after the first dose
Adverse Events
Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs)
Measured: Baseline up to 30 days after the last dose of study drug, up to 1 year
Secondary outcomes (9)
Cmax of JSKN003
Maximum (Peak) Observed blood Concentration (Cmax) of JSKN003 Following First Dose
Measured: Post last dose up to Day 90
Tmax of JSKN003
Time of Maximum blood Concentration (Tmax) of JSKN003 Following First Dose
Measured: Post last dose up to Day 90
AUC of JSKN003
The blood PK parameters of JSKN003 and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.
Measured: Post last dose up to Day 90
Terminal Elimination Half-life (t1/2)
The blood PK parameters of Terminal elimination half-life for JSKN003
Measured: Post last dose up to Day 90
ORR
Objective response rate (ORR) by independent central 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: Postdose of last participant up to 1 year
TTR
TTR is defined as the time from the date of first study dose to the date of earliest qualifying response
Measured: Postdose of last participant up to 1 year
DoR
Duration of response for responders (CR or PR) is defined as the time interval between the date of earliest qualifying response and the date of PD or death for any cause, whichever occurs earlier.
Measured: Postdose of last participant up to 1 year
PFS
PFS is defined as the time from the date of first study dose to disease progression or death whichever occurs first. Subjects without event (no disease progression or alive at last visit) will be censored at the date of "last tumor assessment".
Measured: Postdose of last participant up to 1 year
Anti-JSKN003 antibody
Status (positive or negative) and serum titers of anti-JSKN003 antibody
Measured: Post last dose up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start2 Sep 2022
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
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.
- 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
- Sequential
- Model description
- The starting dose of JSKN003 is 1.0 mg/kg, followed by 2.1, 4.2, 5.3, 6.3, 7.3, 8.4, 9.4 and 10.5 mg/kg.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alphamab (Australia) Co Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arlene Chan, Principal investigator, Breast Cancer Research Centre-WA,Hollywood Consulting Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494918
- Sponsor's protocol ID
- JSKN003-101
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open-label, Dose Escalation, First-In-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of JSKN003 in Subjects With Advanced or Metastatic Solid Malignant Tumors
- ClinicalTrials.gov ID
- NCT05494918
- Acronym / sponsor ID
- JSKN003-101
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Alphamab (Australia) Co Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 10 Aug 2022 (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, dose escalation study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of JSKN003 in subjects with advanced inoperable or metastatic solid malignant tumors that are expected to be HER2 expression.
Detailed description
The dose escalation study will utilize single patient accelerated dose titration for the first two dose levels, 1.0 and 2.1 mg/kg, followed by dose cohorts 4.2, 5.2, 6.3, 7.3, and 8.4 mg/kg which will all be enrolled and monitored using the Bayesian optimal interval design, aimed at determining the MTD, RDE/RP2D of JSKN003. The dose-escalation of 9.4 mg/kg and 10.5 mg/kg should be determined per discussion between Safety Monitoring Committee and sponsor if deemed necessary, the SMC had the right of deciding to dose-escalate at other dose levels . Moreover, the SMC is also responsible for deciding the MTD and the recommended dose level for dose-expansion study.
Enrolled patients will be sequentially assigned to the planned dose levels as required by the protocol and treated with JSKN003 IV Q3W to observe the occurrence of treatment related AEs and dose limiting toxicities. The DLT observation period is 21 days from administration of the first dose of JSKN003.
The study will use a modified ADT design and BOIN design for dosing cohort management to determine the MTD and RDE/RP2D. The starting dose of JSKN003 is 1.0 mg/kg, followed by 2.1, 4.2, 5.3, 6.3, 7.3, 8.4, 9.4 and 10.5 mg/kg. The investigational product will be administered on Day 1 every 3 weeks via intravenous infusion, and the first cycle of JSKN003 treatment is for DLT evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The starting dose of JSKN003 is 1.0 mg/kg, followed by 2.1, 4.2, 5.3, 6.3, 7.3, 8.4, 9.4 and 10.5 mg/kg.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: JSKN003It's a dose escalation to identify the Maximum Tolerated dose (MTD) , recommended dose for expansion (RDE) or recommended Phase II dose (RP2D) of JSKN003, guided by the modified ADT design and BOIN design. |
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 signed informed consent form (ICF) for the trial.
- Male or female, 18 years of age or older; willing and able to comply with study requirements.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 with no deterioration within 2 weeks of scheduled study treatment, and life expectancy ≥ 12 weeks.
- Must have a pathologically documented advanced/unresectable or metastatic solid malignant tumor with HER-2 expression (IHC ≥ 1+) that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- 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 (22 listed)
- Clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, with following exceptions:
- Concurrent malignancy within 5 years prior to entry 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 intercurrent illness including but not limited to:
- 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 |
|---|---|---|
| JSKN003Also: anti-Her2 ADC JSKN003JSKN003 is to be administered via intravenous (IV) dose | Drug | Dose escalation |
Primary outcome
MTD
Time frame: Postdose of last participant up to 1 year
Maximum tolerated dose
Preliminary RDE/RP2D
Time frame: Postdose of last participant up to 1 year
recommended dose for expansion / recommended phase 2 dose
DLTs
Time frame: Baseline up to 21 days after the first dose
Dose Limiting Toxicities
Adverse Events
Time frame: Baseline up to 30 days after the last dose of study drug, up to 1 year
Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs)
9 secondary outcomes
Cmax of JSKN003
Time frame: Post last dose up to Day 90
Tmax of JSKN003
Time frame: Post last dose up to Day 90
AUC of JSKN003
Time frame: Post last dose up to Day 90
Terminal Elimination Half-life (t1/2)
Time frame: Post last dose up to Day 90
ORR
Time frame: Postdose of last participant up to 1 year
TTR
Time frame: Postdose of last participant up to 1 year
DoR
Time frame: Postdose of last participant up to 1 year
PFS
Time frame: Postdose of last participant up to 1 year
Anti-JSKN003 antibody
Time frame: Post last dose up to Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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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.
Arlene Chan principal investigator
Breast Cancer Research Centre-WA,Hollywood Consulting Centre
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 JSKN003 in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Alphamab (Australia) Co Pty 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 22 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: finished, as of the sponsor's last update on 22 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MTD (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 22 Aug 2025.