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RecruitingNCT07617727Updated Aug 26, 2026

A Phase I Study of JSKN021 in Advanced Solid Tumors

A Phase 1 interventional study of JSKN021 in Advanced Malignant Solid Tumors, sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd. Recruiting at 10 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
199
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Malignant Solid Tumors

Keywords

  • EGFR/HER3
  • JSKN021
03

In context

Lead sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd is the lead sponsor of 38 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily participate and sign the informed consent form.
  2. Age ≥ 18 years old, male or female.
  3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  4. Expected survival ≥ 3 months.
  5. 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.
  6. At least one measurable lesion at baseline according to RECIST 1.1 criteria.
  7. Adequate organ function.
  8. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
  9. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
  10. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
  11. Adequate washout period of previous therapy before the first dose.

Exclusion criteria

Exclusion Criteria:

  1. Complicated with other malignant tumors within 3 years before the first dose.
  2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
  3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
  4. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
  5. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
  6. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
  7. Uncontrolled infection.
  8. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
  9. Toxicity of previous anti-tumor treatment has not fully or partially recovered.
  10. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
  11. Pregnant and/or lactating women, or planning to become pregnant during the study period.
  12. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
199 participants (estimated)

Study arms

  • Experimental
    Dose escalation cohort 1

    Drug: JSKN021

  • Experimental
    Dose escalation cohort 2

    Drug: JSKN021

  • Experimental
    Dose escalation cohort 3

    Drug: JSKN021

  • Experimental
    Dose escalation cohort 4

    Drug: JSKN021

  • Experimental
    Dose escalation cohort 5

    Drug: JSKN021

  • Experimental
    Dose escalation cohort 6

    Drug: JSKN021

  • Experimental
    Dose optimization cohort 1

    Drug: JSKN021

  • Experimental
    Dose optimization cohort 2

    Drug: JSKN021

Interventions

  • DrugJSKN021

    JSKN021 administered intravenously at selected dose levels according to protocol

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. Dose-limiting toxicity (DLT)

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

    Time frame: 21 days from the first dose

  3. Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.

    Based on safety and efficacy data.

    Time frame: Up to 24 months

Secondary outcomes

  1. 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）

    Time frame: Up to 24months

  2. Duration of response (DoR)

    Duration of response (DoR) assessed according to RECIST v1.1.

    Time frame: Up to 24months

  3. Disease control rate (DCR)

    Disease control rate (DCR) assessed according to RECIST v1.1.

    Time frame: Up to 24months

  4. 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).

    Time frame: Up to 24months

  5. Overall survival(OS)

    Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.

    Time frame: Up to 24months

  6. Immunogenicity

    Incidence and titer changes of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs, if applicable)

    Time frame: Up to 24months

  7. Maximum concentration (Cmax) of JSKN021

    Maximum concentration (Cmax) of JSKN021

    Time frame: Up to 24months

  8. Time to maximum concentration (Tmax) of JSKN021

    Time to maximum concentration (Tmax) of JSKN021

    Time frame: Up to 24 months.

  9. Trough concentration (Ctrough) of JSKN021

    Trough concentration (Ctrough) of JSKN021

    Time frame: Up to 24 months

  10. Area under the concentration-time curve of JSKN021

    Area under the concentration-time curve of JSKN021

    Time frame: Up to 24 months

  11. Volume of distribution (V) of JSKN021

    Volume of distribution (V) of JSKN021

    Time frame: Up to 24 months

  12. Elimination half-life (t1/2) of JSKN021

    Elimination half-life (t1/2) of JSKN021

    Time frame: Up to 24 months

  13. Clearance (CL) of JSKN021

    Clearance (CL) of JSKN021

    Time frame: Up to 24 months

07

Study locations

10 of 10 sites recruiting
  • Fujian Cancer Hospital
    Fuzhou, Fujian 350014, China
    Recruiting
  • Tumor Hospital of Guangxi Medical University
    Nanning, Guangxi, China
    Recruiting
  • Harbin Medical University Cancer Hospital
    Harbin, Heilongjiang 150081, China
    Recruiting
  • Hubei Cancer Hospital
    Wuhan, Hubei 430079, China
    Recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
    Recruiting
  • Jiangsu Province Hospital
    Nanjing, Jiangsu, China
    Recruiting
  • Xuzhou Central Hospital
    Xuzhou, Jiangsu, China
    Recruiting
  • Affiliated Hospital of Jining Medical College
    Jining, Shandong, China
    Recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Tianjin Medical University Cancer Institute & Hospital
    Tianjin, Tianjin Municipality 300060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07617727
Lead sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Responsible party
Sponsor
First posted
Jun 1, 2026
Start date
Jun 2, 2026
Primary completion
Oct 31, 2028 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Aug 26, 2026

Study contacts

Jian Zhang, MD
Contact
syner2000@163.com
08602134778299

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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