Trials / Not Yet Recruiting
Not Yet RecruitingNCT07036185
A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
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
| Type | Name | Description |
|---|---|---|
| DRUG | KJ015 Injection (Subcutaneous Injection) | KJ015 is administered via subcutaneous injection, with the dosing frequency set at either Q3W. |
Timeline
- Start date
- 2025-06-24
- Primary completion
- 2026-12-31
- Completion
- 2027-04-30
- First posted
- 2025-06-25
- Last updated
- 2025-06-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07036185. Inclusion in this directory is not an endorsement.