A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
NCT07117214 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-08-12
Summary
This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of \[68Ga\]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative (HR+/HER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small Cell Lung Cancer (aNSCLC) adenocarcinoma.
Conditions
- Breast Neoplasms
- Carcinoma, Non-Small-Cell Lung
Interventions
- DRUG
-
[68Ga]Ga-DWJ155
Radioligand imaging agent
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-20
- Primary Completion
- 2027-01-26
- Completion
- 2027-01-26
More Related Trials
-
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
NCT06341894 ·Status: RECRUITING ·Phase: PHASE2
-
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
NCT06341647 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Phase I Dose Escalation Study of Single Fraction Pre-operative Partial Breast (S-PBI) for Early Stage Breast Cancer
NCT04040569 ·Status: ACTIVE_NOT_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
-
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients
NCT06635447 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with HER2+ Breast Cancer
NCT05149014 ·Status: COMPLETED
-
Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer
NCT01476111 ·Status: TERMINATED
-
Efficacy and Safety of Dalpiciclib Plus Toremifene in the Treatment of Advanced First-line HR Positive and HER2 Negative Breast Cancer: a Multicenter, Single Arm, Exploratory Phase II Clinical Study
NCT06495515 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
NCT01598077 ·Status: COMPLETED ·Phase: PHASE1
-
Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC
NCT06817525 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
NCT07062965 ·Status: RECRUITING ·Phase: PHASE3
-
High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)
NCT04247633 ·Status: UNKNOWN ·Phase: PHASE2
-
An Observational Study of Avastin (Bevacizumab) in Patients With HER2-metastatic or Locally Advanced Breast Cancer
NCT01461044 ·Status: COMPLETED
-
Tumor Markers for Efficacy of Dual-Target Therapy in HER2+ Breast Cancer
NCT07115095 ·Status: COMPLETED ·Phase: NA
-
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
NCT05594095 ·Status: RECRUITING ·Phase: PHASE2
-
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
NCT06714617 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).
NCT03742349 ·Status: TERMINATED ·Phase: PHASE1
-
Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer
NCT03696771 ·Status: COMPLETED ·Phase: PHASE1
-
Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer
NCT06711055 ·Status: RECRUITING
-
Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
NCT06121570 ·Status: RECRUITING ·Phase: PHASE1
-
The Exploration of Novel Radionuclide-labeled HER2-targeting Antibodies in the Diagnosis of HER2-positive Malignancies
NCT07023861 ·Status: ENROLLING_BY_INVITATION ·Phase: EARLY_PHASE1
-
A Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer
NCT02131506 ·Status: TERMINATED ·Phase: PHASE1
-
Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment
NCT07281833 ·Status: RECRUITING ·Phase: PHASE3
-
Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC
NCT05918328 ·Status: RECRUITING ·Phase: PHASE2
-
RWS of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody
NCT06481553 ·Status: ACTIVE_NOT_RECRUITING