Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer
NCT03696771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2022-02-04
Summary
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies
Conditions
- NON-breast HER2+ Malignancies
Interventions
- DRUG
-
NJH395
Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent
Sponsors & Collaborators
- 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
- 2018-12-27
- Primary Completion
- 2020-10-19
- Completion
- 2020-10-19
- FDA Drug
- Yes
Countries
- United States
- Italy
- Japan
- South Korea
Study Locations
More Related Trials
-
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
NCT05957536 ·Status: RECRUITING ·Phase: PHASE1
-
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
-
Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer
NCT03451162 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
NCT07334119 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
NCT06198751 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase 1, Multiple Ascending Dose Study of Anti-HER2 FCAB FS102 in HER2 Positive Solid Tumors (Anti HER2 Fcab)
NCT02286219 ·Status: COMPLETED ·Phase: PHASE1
-
De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients
NCT06700369 ·Status: RECRUITING
-
Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer
NCT05154396 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
NCT05911958 ·Status: RECRUITING ·Phase: PHASE2
-
Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC
NCT05918328 ·Status: RECRUITING ·Phase: PHASE2
-
Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer
NCT03619681 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
NCT06341894 ·Status: RECRUITING ·Phase: PHASE2
-
SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression
NCT07047443 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
NCT06075810 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
NCT05514717 ·Status: RECRUITING ·Phase: PHASE1
-
Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
NCT03842085 ·Status: RECRUITING ·Phase: PHASE1
-
Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations
NCT06519110 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer
NCT03596658 ·Status: TERMINATED ·Phase: PHASE1
-
Study Evaluating HKI-272 in Tumors
NCT00146172 ·Status: COMPLETED ·Phase: PHASE1
-
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer
NCT02215876 ·Status: WITHDRAWN ·Phase: PHASE2
-
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
NCT05594095 ·Status: RECRUITING ·Phase: PHASE2
-
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
-
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
NCT05635487 ·Status: RECRUITING ·Phase: PHASE2