Clinical trials: Breast Neoplasms, Triple-Negative
HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies
The goal of this Phase 1/2a interventional study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer.
- Conditions
- HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Prostate Cancer
- Trial name
- NCT07730125
- Testing
- CRG-150
- Volunteers
- 67 people
- Sponsor
- CoRegen, Inc.
Non-small Cell Lung Cancer, Colorectal Cancer
ARGONAUT: Stool and Blood Sample Bank for Cancer Patients
ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the…
- Conditions
- Non-small Cell Lung Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Pancreas Cancer
- Trial name
- NCT04638751
- Testing
- Immunotherapy, Chemotherapy, CRC surgical resection
- Where
- 10 sites in United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Persephone Biosciences
Solid Tumors, Advanced Triple Negative Breast Cancer
A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors
This is a Phase 1b/2a dose escalation and expansion, multi-center study to be conducted in 2 phases: Phase 1b Dose Escalation Part 1 (Doublet Therapy) Dose Escalation Part 2 (Triplet Therapy) Phase 2a Dose Expansion (Triplet…
- Conditions
- Solid Tumors, Advanced Triple Negative Breast Cancer, Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer, Advanced Metastatic Castration-Resistant Prostate Cancer
- Trial name
- NCT03861403
- Testing
- TRX518, Cyclophosphamide, Avelumab
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Leap Therapeutics, Inc.
Locally Advanced or Metastatic Solid Tumor(s), Prostate Cancer
A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors
The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.
- Conditions
- Locally Advanced or Metastatic Solid Tumor(s), Prostate Cancer, Esophageal Cancer, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT04424641
- Testing
- GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4.
- Where
- 6 sites in United States, Denmark and 2 more
- Volunteers
- 48 people
- Sponsor
- Genmab
TNBC - Triple-Negative Breast Cancer
Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery
This is a Phase 3 trial to compare SRG-514 (active pharmaceutical ingredient [API]: ketorolac) administered intraoperatively to the tumor resection cavity with standard-of-care (SOC) versus SOC alone in participants with clinical…
- Trial name
- NCT07723469
- Testing
- BCS + SRG-514, BCS
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- SURGE Therapeutics
Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors
This study will evaluate the safety, tolerability, and preliminary antitumor activity of CAN04 both as a monotherapy and in combination with standard of care treatment in subjects with solid cancer tumors.
- Conditions
- Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Triple Negative Breast Cancer, Colorectal Cancer
- Trial name
- CANFOUR (NCT03267316)
- Testing
- CAN04, Cisplatin, Gemcitabine
- Where
- 25 sites in Austria, Belgium and 9 more
- Volunteers
- 167 people
- Sponsor
- Cantargia AB
Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab…
- Trial name
- START-002 (NCT06827613)
- Testing
- STAR0602, Sacituzumab Govitecan (SG)
- Where
- 8 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Marengo Therapeutics, Inc.
Advanced Solid Tumors, Hematologic Neoplasms
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with…
- Conditions
- Advanced Solid Tumors, Hematologic Neoplasms, Ovarian Cancer, HER2-positive Advanced Solid Tumors
- Trial name
- NCT03219268
- Testing
- tebotelimab 1 mg, tebotelimab 3 mg, tebotelimab 10 mg
- Where
- 40 sites in United States, Australia and 6 more
- Volunteers
- 277 people
- Sponsor
- MacroGenics
Breast Cancer
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with…
- Trial name
- NCT06112379
- Testing
- Dato-DXd, Durvalumab, Pembrolizumab
- Where
- 283 sites in United States, Australia and 24 more
- Volunteers
- 1,902 people
- Sponsor
- AstraZeneca
Melanoma, Non-Small Cell Lung Cancer
A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors
This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in…
- Conditions
- Melanoma, Non-Small Cell Lung Cancer, Bladder Cancer, Colorectal Cancer
- Trial name
- NCT03289962
- Testing
- Autogene cevumeran, Atezolizumab
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 273 people
- Sponsor
- Genentech, Inc.
Cancer of the Breast, Breast Cancer
CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)
The goal of this clinical study is to determine the safety, pharmacokinetics, pharmacodynamics and efficacy and activity of seviteronel, a lyase-selective inhibitor of CYP17, in patients with advanced breast cancer.
- Conditions
- Cancer of the Breast, Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- CLARITY-01 (NCT02580448)
- Testing
- Seviteronel
- Where
- 36 sites in United States
- Volunteers
- 175 people
- Sponsor
- Innocrin Pharmaceutical
PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with…
- Trial name
- NCT07111832
- Testing
- SHR-A1811 for Injection, SHR-1316 Injection, Toripalimab Injection
- Where
- 2 sites in China
- Volunteers
- 400 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
PDL1 Gene Mutation, Non Small Cell Lung Cancer
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability of 177Lu-RAD204 in participants with selected solid tumors, and to determine the MTD and/or recommended dose for future exploration.
- Conditions
- PDL1 Gene Mutation, Non Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), TNBC, Triple Negative Breast Cancer
- Trial name
- NCT06305962
- Testing
- 177Lu-RAD204
- Where
- 6 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd
Metastatic Breast Cancer, Triple Negative Breast Cancer
Triple Negative Breast Cancer Biomarker Study
Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are scheduled for medically indicated surgical biopsy or resection of disease will be identified.
- Trial name
- NCT01111175
- Where
- 18 sites in United States
- Volunteers
- 14 people
- Sponsor
- US Oncology Research
Advanced Solid Tumor
Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients with Advanced Solid…
- Trial name
- NCT06249048
- Testing
- STX-001, Keytruda®
- Where
- 7 sites in United States, Australia
- Volunteers
- 108 people
- Sponsor
- Strand Therapeutics Inc.
Non-Small Cell Lung Cancer, Renal Cell Cancer
CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers.
- Conditions
- Non-Small Cell Lung Cancer, Renal Cell Cancer, Colorectal Cancer, Triple Negative Breast Cancer
- Trial name
- NCT03454451
- Testing
- CPI-006, CPI-006 + ciforadenant, CPI-006 + pembrolizumab
- Where
- 27 sites in United States, Australia
- Volunteers
- 117 people
- Sponsor
- Corvus Pharmaceuticals, Inc.
Solid Tumor, Adult
A Tissue Collection Study in Patients Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells.
T Cell Receptor-engineered T-cell therapy (TCR T-cell therapy) offers a potentially transformative approach to treating cancer, but is currently limited by the lack of known targets (Maus and June, 2016; Ping et al., 2018).
- Trial name
- NCT05230186
- Testing
- Tumor Biopsy
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- TScan Therapeutics, Inc.
Breast Cancer
Study of Pembrolizumab (MK-3475) Monotherapy for Metastatic Triple-Negative Breast Cancer (MK-3475-086/KEYNOTE-086)
This is a two-part study of pembrolizumab monotherapy in participants with metastatic triple-negative breast cancer (mTNBC). Part 1 of the study will examine the efficacy and safety of pembrolizumab monotherapy as first line or…
- Trial name
- NCT02447003
- Testing
- Pembrolizumab
- Volunteers
- 254 people
- Sponsor
- Merck Sharp & Dohme LLC
Triple Negative Breast Cancer, Diffuse Large B Cell Lymphoma
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral…
- Conditions
- Triple Negative Breast Cancer, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Lymphoma, Non-Hodgkin
- Trial name
- ON-5001 (NCT06022029)
- Testing
- ONM-501, Cemiplimab
- Where
- 16 sites in United States, Australia
- Volunteers
- 168 people
- Sponsor
- OncoNano Medicine, Inc.
Epithelial Tumors, Malignant
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.
- Trial name
- MYE Symphony (NCT05969041)
- Testing
- MT-302 (A)
- Where
- 6 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Myeloid Therapeutics