A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors
NCT07036185 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2025-06-25
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
Interventions
- DRUG
-
KJ015 Injection (Subcutaneous Injection)
KJ015 is administered via subcutaneous injection, with the dosing frequency set at either Q3W.
Sponsors & Collaborators
-
Shanghai Bao Pharmaceuticals Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-24
- Primary Completion
- 2026-12-31
- Completion
- 2027-04-30
Countries
- China
Study Locations
More Related Trials
-
A Study of DP303c in Patients With HER2-positive Advanced Solid Tumors
NCT05810103 ·Status: UNKNOWN ·Phase: PHASE1
-
A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer
NCT05629949 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
NCT06115902 ·Status: RECRUITING ·Phase: PHASE1
-
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
NCT06057610 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of DP303c Administered Intravenously to Subjects With HER2-Positive in Advanced Solid Tumors
NCT04146610 ·Status: UNKNOWN ·Phase: PHASE1
-
Pyrotinib in HER2-positive Early Breast Cancer
NCT06718335 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
NCT06210776 ·Status: RECRUITING
-
DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
NCT06313086 ·Status: RECRUITING ·Phase: PHASE3
-
Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer
NCT03153163 ·Status: COMPLETED ·Phase: PHASE1
-
JAK1 Inhibitor Ivarmacitinib Reversing Immunotherapy Resistance in TNBC
NCT06731153 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC
NCT07007780 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
NCT05861895 ·Status: RECRUITING ·Phase: PHASE1
-
A Trial of HRS-6768 in Patients With Advanced Solid Tumors
NCT06925581 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
NCT06293898 ·Status: RECRUITING ·Phase: PHASE1
-
The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
NCT06452706 ·Status: RECRUITING ·Phase: PHASE2
-
Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer
NCT07008976 ·Status: RECRUITING ·Phase: PHASE3
-
A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance
NCT07321015 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
NCT07180082 ·Status: RECRUITING ·Phase: PHASE2
-
TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer
NCT07047365 ·Status: RECRUITING ·Phase: PHASE3
-
A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
NCT07196774 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of A166 in Patients With Advanced Solid Malignant Tumors
NCT05311397 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
NCT06341647 ·Status: WITHDRAWN ·Phase: PHASE1
-
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
NCT05838066 ·Status: RECRUITING ·Phase: PHASE3
-
IKS014 in Advanced Solid Tumors That Express HER2
NCT05872295 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
NCT06431490 ·Status: RECRUITING ·Phase: PHASE1/PHASE2