AzTrials
AzTrials

Advanced Malignant Solid TumorPhase 1NCT07391644

A Study of JSKN027 in Patients With Advanced Solid Tumors

A Phase 1 study testing JSKN027 in people with Advanced Malignant Solid Tumor, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a first-in-human, open-label, multicenter Phase 1 (Ia/Ib) clinical study conducted in China to evaluate the safety and tolerability of JSKN027 in patients with advanced malignant solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Solid Tumor
What is being tested?
JSKN027
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteChina
Study dates
15 Mar 2026to 30 Jun 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at the time of signing the ICF.
  • ECOG performance status 0-1.
  • Estimated life expectancy ≥ 3 months.
  • Histologically or cytologically confirmed advanced or metastatic malignant solid tumor.
  • For dose escalation (Part Ia): disease has progressed on standard therapy.
  • For dose expansion (Part Ib): participants with prespecified tumor types (e.g., colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and other selected solid tumors) who have progressed on standard therapy.
Show all 14Show fewer
  • At least one measurable extracranial lesion per RECIST v1.1.
  • Adequate bone marrow function within 7 days prior to enrollment (e.g., ANC ≥ 1.5×10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100×10^9/L).
  • Adequate hepatic function within 7 days prior to enrollment (e.g., total bilirubin, AST/ALT, ALP within protocol-defined limits; albumin ≥ 30 g/L).
  • Adequate renal function within 7 days prior to enrollment (e.g., serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min; urine protein within acceptable limits).
  • Adequate coagulation function within 7 days prior to enrollment (e.g., PT/INR and aPTT within protocol-defined limits).
  • Adequate cardiac function (e.g., LVEF ≥ 50%).
  • Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
  • Participants of reproductive potential agree to use highly effective contraception from ICF signing until 7 months after the last dose.

Who cannot join

  • Active central nervous system (CNS) disease (e.g., active brain metastases or leptomeningeal disease).
  • Received an investigational agent within 28 days or 5 half-lives (whichever is shorter) prior to first dose.
  • Major surgery within 28 days prior to first dose or planned major surgery during the study.
  • History of severe immune-related adverse events or prior toxicity that would preclude safe participation, as judged by the investigator.
  • Significant gastrointestinal disorders that increase risk of perforation, bleeding, obstruction, or interfere with study participation.
  • Active or uncontrolled interstitial lung disease (ILD) or non-infectious pneumonitis, or suspected ILD/pneumonitis at screening.
Show all 12Show fewer
  • Active autoimmune disease requiring systemic immunosuppression (exceptions may apply for limited, stable conditions).
  • Active hepatitis B or C, HIV infection, or other clinically significant immunodeficiency/infection not adequately controlled per local standards.
  • Prior allogeneic organ or bone marrow transplant.
  • Known hypersensitivity to the study drug or its excipients, or history of severe hypersensitivity to similar biologic agents.
  • Pregnant or breastfeeding.
  • Any condition that, in the investigator's judgment, would compromise participant safety or compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Enrollment Contact contact

+86-1 5 2 0 1 3 9 3 1 2 0

ruiliu@alphamabonc.com

China1 site

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, MD, +86-10-88121122, shenlin@bjmu.edu.cn

Other trials in China

About this study

Official title: A First-in-Human, Open-Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of JSKN027 in Patients With Advanced Malignant Solid Tumors

This is a first-in-human, open-label, multicenter Phase 1 (Ia/Ib) clinical study conducted in China to evaluate the safety and tolerability of JSKN027 in patients with advanced malignant solid tumors. The study will also assess the pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of JSKN027, and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).

The study includes two parts. Part Ia is a dose-escalation phase designed to evaluate the safety and tolerability of increasing dose levels of JSKN027. Part Ib is a dose-expansion phase in which additional patients will be enrolled at selected dose levels to further evaluate safety and preliminary antitumor activity in specific tumor types. Initial expansion cohorts are planned for patients with colorectal cancer, non-small cell lung cancer, and hepatocellular carcinoma.

Read the detailed description

This is a first-in-human, open-label, multicenter Phase 1 (Ia/Ib) clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of JSKN027 in patients with advanced malignant solid tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).

The study consists of two parts: a dose-escalation phase (Part Ia) and a dose-expansion phase (Part Ib). In Part Ia, an accelerated titration design followed by an i3+3 dose-escalation design will be used to evaluate multiple dose levels of JSKN027 and assess its safety and tolerability. In Part Ib, multiple expansion cohorts will be enrolled based on tumor type to further evaluate the safety and preliminary efficacy of JSKN027 at selected dose levels. Initial expansion cohorts are planned for patients with colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and hepatocellular carcinoma (HCC).

Being tested
JSKN027

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSKN027Drug

    JSKN027 is an investigational therapeutic agent being evaluated for the treatment of advanced malignant solid tumors. It is administered as intravenous monotherapy at multiple dose levels in this study.

Study groups in NCT07391644
Study groupRoleWhat they receive
JSKN027ExperimentalParticipants will receive JSKN027 administered by intravenous infusion at dose levels based on actual body weight (mg/kg). The planned dose levels are 1, 3, 6, 10, 15, and 20 mg/kg, administered once every 3 weeks (Q3W).
Receives: Drug: JSKN027

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose-Limiting Toxicities (DLTs)

    The number of participants who experience dose-limiting toxicities (DLTs) during the dose-limiting toxicity evaluation period following administration of JSKN027

    Measured: From first dose of JSKN027 through 21 days after the first dose (DLT evaluation period)

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    The number of participants who experience treatment-emergent adverse events (TEAEs) following administration of JSKN027, graded according to NCI CTCAE version 5.0.

    Measured: From first dose of JSKN027 through 30 days after the last dose

  3. Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of JSKN027

    Determination of the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of JSKN027 based on observed dose-limiting toxicities and overall safety and tolerability.

    Measured: From first dose of JSKN027 through completion of dose-escalation phase (approximately 12 months)

Secondary outcomes (5)

  1. Objective Response Rate (ORR) as Assessed by RECIST v1.1

    Objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST version 1.1.

    Measured: From first dose of JSKN027 until disease progression or death, up to 24 months

  2. Disease Control Rate (DCR) as Assessed by RECIST v1.1

    Disease control rate (DCR), defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to RECIST version 1.1.

    Measured: From first dose of JSKN027 until disease progression or death, up to 24 months

  3. Duration of Response (DoR) as Assessed by RECIST v1.1

    Duration of response (DoR), defined as the time from first documented objective response (CR or PR) to disease progression or death, as assessed according to RECIST version 1.1.

    Measured: From first documented response until disease progression or death, up to 24 months

  4. Progression-Free Survival (PFS)

    Progression-free survival (PFS), defined as the time from first dose of JSKN027 to the first documentation of disease progression or death from any cause.

    Measured: From first dose of JSKN027 until disease progression or death, up to 24 months

  5. Overall Survival (OS)

    Overall survival (OS), defined as the time from first dose of JSKN027 to death from any cause.

    Measured: From first dose of JSKN027 until death from any cause, up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start15 Mar 2026 (estimated)
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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
Single group
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07391644
Sponsor's protocol ID
JSKN027-101
Status last verified
Jan 2026
First submitted
30 Jan 2026
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JSKN027 in people with Advanced Malignant Solid Tumor, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site 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 14 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: opening soon, as of the sponsor's last update on 6 Feb 2026. 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 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 Clinical Trial Enrollment Contact (+86-1 5 2 0 1 3 9 3 1 2 0, ruiliu@alphamabonc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: From first dose of JSKN027 through 21 days after the first dose (DLT evaluation period)). 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?

On the ClinicalTrials.gov record for NCT07391644.

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 6 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in