AzTrials
AzTrials

Gastric/Gastroesophageal Junction CancerPhase 1NCT07036185

A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors

A Phase 1 study testing KJ015 Injection (Subcutaneous Injection) in people with Gastric/Gastroesophageal Junction Cancer and Breast Cancer, run by Shanghai Bao Pharmaceuticals 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 an open-label, multicenter, Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of KJ015 administered subcutaneously in participants with HER2-expressing solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KJ015 Injection (Subcutaneous Injection)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
24 Jun 2025to 30 Apr 2027
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

  • Aged ≥ 18 years (at time of free and informed consent).
  • Participants must have radiographically confirmed progressive disease (PD) during the last treatment prior to the first dose of enrollment.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) Dose Escalation Part: ECOG performance status 0 to 1;Backfill Part: ECOG performance status0 to 2.
  • Participants must be have HER 2 positive or HER 2 expressing tumors determined by a certified local or central clinical laboratory or hospital
  • Organ function must meet the following criteria:
  • i.Hemoglobin (Hb) ≥ 9.0 g/dL ii.Absolute neutrophil count (ANC) ≥ 1.0 × 109/L iii.Platelet count (PLT) ≥ 80 × 109/L v.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN if no liver lesions (primary or metastatic); ALT and AST ≤ 5 × ULN if liver lesions are present vi.Creatinine clearance ≥ 30 mL/min vii.Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN viii. Serum albumin ≥ 25 g/L (2.5 g/dL).
  • Expected survival ≥ 3 months.
  • Participants must be capable of and willing to comply with the visit and procedure requirements outlined in the protocol.

Who cannot join

  • Concurrent participation in another clinical study.
  • Received radiotherapy within 2 weeks prior to the first dose.
  • Underwent major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose or plan to undergo major surgery during the study. Underwent interventional or ablation surgery aimed at treating the tumor within 2 weeks before the first dose.
  • Prior allogeneic bone marrow transplant or prior solid organ transplant.
  • Received systemic corticosteroids or other immunosuppressive treatments within 2 weeks prior to the first dose.
  • Received an anthracycline cumulative dose of doxorubicin exceeding 500 mg/m2 or an equivalent dose of other anthracyclines prior to the first dose.
Show all 11Show fewer
  • History of leptomeningeal carcinomatosis or carcinomatous meningitis.
  • Brain metastasis or spinal cord compression.
  • Uncontrolled or clinically significant cardiovascular or cerebrovascular disease.
  • History of a serious allergic reaction to the investigational product, an inactive ingredient in the investigational product, or other monoclonal antibody.
  • Women who are pregnant or breastfeeding as confirmed by pregnancy testing within 3 days prior to first dose.

Trial locations and contacts

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

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200120

    Jian Zhang, MD

Other trials in China

About this study

Official title: An Open-Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of KJ015 Injection (Subcutaneous Injection) in Patients With HER2-Expressing Solid Tumors

This is an open-label, multicenter, Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of KJ015 administered subcutaneously in participants with HER2-expressing solid tumors.

Read the detailed description

This is an open-label, multicenter, Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of KJ015 administered subcutaneously in participants with HER2-expressing solid tumors. The study will be conducted in 2 parts: the first part is the dose escalation part, and the second part is the Backfill part (as determined by the Sponsor). The dose escalation part will evaluate the safety and tolerability of KJ015 in participants with HER2-expressing locally advanced or metastatic solid tumors who have no standard therapy, are ineligible for surgical resection, or are not suitable for standard therapy or other approved therapies but have an inadequate clinical response. The Backfill part will further characterize the preliminary efficacy and safety of KJ015 in selected participants with solid tumors (including but not limited to G/GEJ, BC, CRC, BDC, HNSCC, NSCLC, etc.) at a minimum of two safe and tolerable dose levels, explore the relationship between the expression levels of HER2 protein and its mRNA and efficacy, as well as the HER 2 protein expression levels, transcription levels, and the correlation with efficacy in antitumor activity after KJ015 treatment.

Being tested
KJ015 Injection (Subcutaneous Injection)
Keywords
KJ015, HER2, solid tumors
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Bile Duct Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • KJ015 Injection (Subcutaneous Injection)Drug

    KJ015 is administered via subcutaneous injection, with the dosing frequency set at either Q3W.

Study groups in NCT07036185
Study groupRoleWhat they receive
KJ015 Injection (Subcutaneous Injection)ExperimentalKJ015 is administered via subcutaneous injection.
Receives: Drug: KJ015 Injection (Subcutaneous Injection)

What is being measured

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

  1. Dose Escalation Part: Adverse Event collection and assessment

    Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the DLTs, maximum tolerated dose (MTD).

    Measured: at least 21 days or up to 24 weeks

  2. Dose Escalation Part: Backfill part recommended extension dose (RED)

    Backfill recommended extension dose

    Measured: at least 21 days or up to 24 weeks

  3. Backfill Part: Adverse Event

    Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability.

    Measured: at least 21 days or up to 24 weeks

Secondary outcomes (10)

  1. Immunogenicity

    Immunogenicity of KJ1015 (Anti-KJ015 antibody) in patients

    Measured: day 1, day 15, every 3 weeks

  2. Objective Response Rate (ORR)

    ORR was defined as the patients with a best overall response of complete response (CR) or partial response (PR) based on local Investigator assessment as defined in RECIST 1.1.

    Measured: at least 12 weeks

  3. Disease Control Rate (DCR)

    DCR was defined as the patients with a best overall response of either CR, PR or stable disease (SD) .

    Measured: at least 12 weeks

  4. Progression-Free Survival（PFS）

    PFS was defined as the time from first dose of study treatment until the date of disease progression or death (by any cause in the absence of progression) regardless whether the patient withdrew from the assigned study treatment or received another anticancer prior to progression.

    Measured: at least 12 weeks

  5. Overall Survival (OS)

    OS was defined as the time from first day of study treatment until death due to any cause.

    Measured: at least 12 weeks

  6. Maximum Observed Plasma Concentration (Cmax)

    Maximum observed serum concentration of KJ015 following dosing (Cmax)

    Measured: Pre-dose, 2-24, 48, 72, 96, 144-480 hours post-dose

  7. Terminal Half-life (t½)

    Half-life of KJ015

    Measured: Pre-dose, 2-24, 48, 72, 96, 144-480 hours post-dose

  8. Area under the serum concentration versustime curve (AUC)

    Area under the serum concentration versustime curve (AUC) of KJ015

    Measured: Pre-dose, 2-24, 48, 72, 96, 144-480 hours post-dose

  9. Apparent Volume of Distribution (Vz)

    The PK (Vz) of KJ015

    Measured: Pre-dose, 2-24, 48, 72, 96, 144-480 hours post-dose

  10. Clearance(CL)

    Clearance(CL) is a measure of the ability of the body to clear KJ015

    Measured: Pre-dose, 2-24, 48, 72, 96, 144-480 hours post-dose

Timeline

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

  1. First posted25 Jun 2025
  2. Study start24 Jun 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Apr 2027 (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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07036185
Sponsor's protocol ID
SHBJ-KJ015-001
Status last verified
Jun 2025
First submitted
10 Jun 2025
Last updated
25 Jun 2025
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 KJ015 Injection (Subcutaneous Injection) in people with Gastric/Gastroesophageal Junction Cancer and Breast Cancer, run by Shanghai Bao Pharmaceuticals 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 8 inclusion and 11 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 25 Jun 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 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?

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?

Dose Escalation Part: Adverse Event collection and assessment (time frame: at least 21 days or up to 24 weeks). 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 NCT07036185.

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 25 Jun 2025.

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