Advanced Malignant Solid TumorsPhase 1NCT07617727
A Phase I Study of JSKN021 in Advanced Solid Tumors
A Phase 1 study testing JSKN021 in people with Advanced Malignant Solid Tumors, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 10 sites in China.
Trial summary
This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- JSKN021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 10 sitesChina
- Study dates
- 2 Jun 2026to 31 May 2029
- 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
- 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.
- 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 3 years before the first dose.
- 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.
- 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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- Uncontrolled infection.
- Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
- Recruiting
Affiliated Hospital of Jining Medical College
Jining, Shandong
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
- Recruiting
Tumor Hospital of Guangxi Medical University
Nanning, Guangxi
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors
This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- JSKN021
- Keywords
- EGFR/HER3, JSKN021
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN021Drug
JSKN021 administered intravenously at selected dose levels according to protocol
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation cohort 1 | Experimental | Not described Receives: Drug: JSKN021 |
| Dose escalation cohort 2 | Experimental | Not described Receives: Drug: JSKN021 |
| Dose escalation cohort 3 | Experimental | Not described Receives: Drug: JSKN021 |
| Dose escalation cohort 4 | Experimental | Not described Receives: Drug: JSKN021 |
| Dose escalation cohort 5 | Experimental | Not described Receives: Drug: JSKN021 |
| Dose escalation cohort 6 | Experimental | Not described Receives: Drug: JSKN021 |
| Dose optimization cohort 1 | Experimental | Not described Receives: Drug: JSKN021 |
| Dose optimization cohort 2 | Experimental | Not described Receives: Drug: JSKN021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021)
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 measures.
Measured: From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
Dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) in each dose group.
Measured: 21 days from the first dose
Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.
Based on safety and efficacy data.
Measured: Up to 24 months
Secondary outcomes (13)
Objective response rate (ORR)
Objective response rate (ORR) 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: Up to 24months
Duration of response (DoR)
Duration of response (DoR) assessed according to RECIST v1.1.
Measured: Up to 24months
Disease control rate (DCR)
Disease control rate (DCR) assessed according to RECIST v1.1.
Measured: Up to 24months
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression or death due to any cause (whichever occurs first).
Measured: Up to 24months
Overall survival(OS)
Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.
Measured: Up to 24months
Immunogenicity
Incidence and titer changes of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs, if applicable)
Measured: Up to 24months
Maximum concentration (Cmax) of JSKN021
Maximum concentration (Cmax) of JSKN021
Measured: Up to 24months
Time to maximum concentration (Tmax) of JSKN021
Time to maximum concentration (Tmax) of JSKN021
Measured: Up to 24 months.
Trough concentration (Ctrough) of JSKN021
Trough concentration (Ctrough) of JSKN021
Measured: Up to 24 months
Area under the concentration-time curve of JSKN021
Area under the concentration-time curve of JSKN021
Measured: Up to 24 months
Volume of distribution (V) of JSKN021
Volume of distribution (V) of JSKN021
Measured: Up to 24 months
Elimination half-life (t1/2) of JSKN021
Elimination half-life (t1/2) of JSKN021
Measured: Up to 24 months
Clearance (CL) of JSKN021
Clearance (CL) of JSKN021
Measured: 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.
- First posted1 Jun 2026
- Study start2 Jun 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The trial consists of two phases: phase Ia dose escalation and phase Ib dose optimization.For dose escalation part,an accelerated titration design (ATD) combined with "i3+3" design will be adopted.
- Masking
- None (open label)
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617727
- Sponsor's protocol ID
- JSKN021-101
- Status last verified
- Aug 2026
- First submitted
- 20 May 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. The informed consent form does not include provisions for sharing de-identified participant-level data with researchers outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07617727
- Acronym / sponsor ID
- JSKN021-101
- Conditions
- Advanced Malignant Solid Tumors
- Keywords
- EGFR/HER3, JSKN021
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 1 Jun 2026 (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, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- The trial consists of two phases: phase Ia dose escalation and phase Ib dose optimization.For dose escalation part,an accelerated titration design (ATD) combined with "i3+3" design will be adopted.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation cohort 1 | Experimental | Drug: JSKN021 |
| Dose escalation cohort 2 | Experimental | Drug: JSKN021 |
| Dose escalation cohort 3 | Experimental | Drug: JSKN021 |
| Dose escalation cohort 4 | Experimental | Drug: JSKN021 |
| Dose escalation cohort 5 | Experimental | Drug: JSKN021 |
| Dose escalation cohort 6 | Experimental | Drug: JSKN021 |
| Dose optimization cohort 1 | Experimental | Drug: JSKN021 |
| Dose optimization cohort 2 | Experimental | Drug: JSKN021 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- Complicated with other malignant tumors within 3 years before the first dose.
- 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.
- 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:
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 |
|---|---|---|
| JSKN021JSKN021 administered intravenously at selected dose levels according to protocol | Drug | Dose escalation cohort 1, Dose escalation cohort 2, Dose escalation cohort 3, Dose escalation cohort 4, Dose escalation cohort 5, Dose escalation cohort 6, Dose optimization cohort 1, Dose optimization cohort 2 |
Primary outcome
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021)
Time frame: From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
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 measures.
Dose-limiting toxicity (DLT)
Time frame: 21 days from the first dose
Incidence of dose-limiting toxicity (DLT) in each dose group.
Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.
Time frame: Up to 24 months
Based on safety and efficacy data.
13 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 24months
Duration of response (DoR)
Time frame: Up to 24months
Disease control rate (DCR)
Time frame: Up to 24months
Progression-Free Survival (PFS)
Time frame: Up to 24months
Overall survival(OS)
Time frame: Up to 24months
Immunogenicity
Time frame: Up to 24months
Maximum concentration (Cmax) of JSKN021
Time frame: Up to 24months
Time to maximum concentration (Tmax) of JSKN021
Time frame: Up to 24 months.
Trough concentration (Ctrough) of JSKN021
Time frame: Up to 24 months
Area under the concentration-time curve of JSKN021
Time frame: Up to 24 months
Volume of distribution (V) of JSKN021
Time frame: Up to 24 months
Elimination half-life (t1/2) of JSKN021
Time frame: Up to 24 months
Clearance (CL) of JSKN021
Time frame: Up to 24 months
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 26 Aug 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared. The informed consent form does not include provisions for sharing de-identified participant-level data with researchers outside the study team.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JSKN021 in people with Advanced Malignant Solid Tumors, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 10 sites 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 11 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 Jian Zhang, MD (08602134778299, syner2000@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 JSKN021) (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 26 Aug 2026.