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

NCT07036185 | Not Yet Recruiting Phase 1

• 1 other identifier: SHBJ-KJ015-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric/Gastroesophageal Junction Cancer; Breast Cancer; Colorectal Cancer; Non-small Cell Lung Cancer (NSCLC); Bile Duct Cancer; Head and Neck Squamous Cell Carcinoma

Keywords

KJ015; HER2; solid tumors

Outcome Measures

Primary Outcomes (3)

• 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).

  at least 21 days or up to 24 weeks

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

  Backfill recommended extension dose

  at least 21 days or up to 24 weeks

• Backfill Part: Adverse Event

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

  at least 21 days or up to 24 weeks

Secondary Outcomes (10)

• Immunogenicity

  day 1, day 15, every 3 weeks

• Objective Response Rate (ORR)

  at least 12 weeks

• Disease Control Rate (DCR)

  at least 12 weeks

• Progression-Free Survival（PFS）

  at least 12 weeks

• Overall Survival (OS)

  at least 12 weeks

Study Arms (1)

KJ015 Injection (Subcutaneous Injection)

EXPERIMENTAL

KJ015 is administered via subcutaneous injection.

Drug: KJ015 Injection (Subcutaneous Injection)

Interventions

KJ015 Injection (Subcutaneous Injection) DRUG

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

KJ015 Injection (Subcutaneous Injection)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Bao Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Bile Duct Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 25, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)