KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor
NCT04040699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-04-09
Summary
This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.
Conditions
- HER2 Positive Solid Tumor
Interventions
- BIOLOGICAL
-
KN026 combined with KN046
KN026 and KN046 are given at 20mg/Kg and 3mg/Kg intravenously on day 1of each 2 weeks cycle at the beginning respectively.The dosage will be escalated if adverse events are tolerated according to the scheme.
Sponsors & Collaborators
-
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
collaborator INDUSTRY -
Peking University
lead OTHER
Principal Investigators
-
Lin Shen, MD,PhD · Peking University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-26
- Primary Completion
- 2022-09-22
- Completion
- 2023-12-01
Countries
- China
Study Locations
More Related Trials
-
Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer
NCT06722612 ·Status: RECRUITING
-
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
NCT06747338 ·Status: RECRUITING ·Phase: PHASE3
-
Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy
NCT06711068 ·Status: RECRUITING
-
Real World Study on the Efficacy and Safety of Anti-HER2 Therapy
NCT05367739 ·Status: COMPLETED
-
Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer
NCT04659499 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
NCT04446260 ·Status: COMPLETED ·Phase: PHASE1
-
De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients
NCT06700369 ·Status: RECRUITING
-
Neoadjuvant Study of Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer (TNBC)
NCT04676997 ·Status: UNKNOWN ·Phase: PHASE2
-
Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer
NCT06711055 ·Status: RECRUITING
-
The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.
NCT05263570 ·Status: RECRUITING
-
Neoadjuvant Inituomab, Pyrrolidone and Nab-paclitaxel for HER2+Breast Cancer
NCT05444998 ·Status: UNKNOWN ·Phase: PHASE2
-
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase I Clinical Study
NCT06770296 ·Status: RECRUITING ·Phase: PHASE1
-
Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer
NCT05525767 ·Status: RECRUITING ·Phase: PHASE4
-
Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC
NCT04001634 ·Status: COMPLETED
-
Phase II Neoadjuvant Pyrotinib Combined with Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
NCT05165225 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Gemcitabine Combined With Eribulin Regimen in the Treatment of Second-line Above Recurrent HER2-negative Breast Cancer
NCT05263882 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of A166 in Patients With Advanced Solid Malignant Tumors
NCT05311397 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
NCT06503783 ·Status: RECRUITING ·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
-
Reverse HER2-negative Immune Resistant Breast Cancer
NCT06731140 ·Status: RECRUITING ·Phase: PHASE2
-
Study of DP303c Administered Intravenously to Subjects With HER2-Positive in Advanced Solid Tumors
NCT04146610 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
NCT06609187 ·Status: RECRUITING ·Phase: PHASE1
-
The Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC
NCT05862610 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study
NCT06254690 ·Status: RECRUITING ·Phase: PHASE2
-
Novel Double Target Therapy Combined With Chemotherapy in First-line Treatment of HER2+ Breast Cancer, MA-BC-II-038
NCT05429294 ·Status: UNKNOWN ·Phase: PHASE2