A Phase I Study of JSKN021 in Advanced Solid Tumors

NCT07617727 | Not Yet Recruiting Phase 1

• 1 other identifier: JSKN021-101
• Study Type: interventional
• Target: 199
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Malignant Solid Tumors

Keywords

EGFR/HER3; JSKN021

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to 24 months

Secondary Outcomes (13)

• Objective response rate (ORR)

  Up to 24months

• Duration of response (DoR)

  Up to 24months

• Disease control rate (DCR)

  Up to 24months

• Progression-Free Survival (PFS)

  Up to 24months

• Overall survival(OS)

  Up to 24months

Study Arms (8)

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

Interventions

JSKN021 DRUG

JSKN021 administered intravenously at selected dose levels according to protocol

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate and sign the informed consent form.
• Age ≥ 18 and ≤ 75 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Central Study Contacts

Jian Zhang, MD

CONTACT

08602134778299; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 1, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share