Clinical trials: Triple-Negative Breast Cancer (TNBC)
Triple Negative Breast Cancer (TNBC)
Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).
This is a Phase Ib, open label, dose escalation study of spartalizumab + LAG525 in combination with NIR178, capmatinib, MCS110, or canakinumab, followed by a dose expansion in adult patients with advanced or metastatic TNBC.
- Trial name
- NCT03742349
- Testing
- spartalizumab, LAG525, NIR178
- Where
- 13 sites in United States, Australia and 7 more
- Volunteers
- 64 people
- Sponsor
- Novartis Pharmaceuticals
Triple-Negative Breast Cancer, High-grade Serous Ovarian Cancer
Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors
This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.
- Conditions
- Triple-Negative Breast Cancer, High-grade Serous Ovarian Cancer, Solid Tumors, NUT Midline Carcinoma
- Trial name
- NCT02307240
- Testing
- CUDC-907
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Curis, Inc.
Advanced Solid Tumors Cancer
Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors
The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics…
- Trial name
- NCT03821935
- Testing
- Livmoniplimab, Budigalimab
- Where
- 64 sites in United States, Australia and 12 more
- Volunteers
- 364 people
- Sponsor
- AbbVie
Clear Cell Renal Cell Carcinoma Metastatic, TNBC - Triple-Negative Breast Cancer
Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours
Carbonic anhydrase IX (CA IX) has been implicated in the progression of most solid tumours and expression has been demonstrated in clinical samples from a variety of solid cancers.
- Conditions
- Clear Cell Renal Cell Carcinoma Metastatic, TNBC - Triple-Negative Breast Cancer, Head and Neck Cancer, Non-small-cell Lung Carcinoma
- Trial name
- CAMP1 (NCT05698238)
- Testing
- CA9hu-1
- Volunteers
- 50 people
- Sponsor
- Mabpro, a.s.
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 19 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
ER-Negative PR-Negative HER2-Negative Breast Cancer
Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBC
Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or subcutaneous disease.
- Trial name
- TNBC (NCT02531425)
- Testing
- IT-pIL12-EP
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- OncoSec Medical Incorporated
Advanced Solid Tumor
A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors
This is a study to evaluate the safety and potential anti-tumor activity of an investigational drug called ARV-6723, in participants with advanced solid tumors.
- Trial name
- NCT07749586
- Testing
- ARV-6723, Pembrolizumab, SOC
- Where
- 4 sites in United States
- Volunteers
- 499 people
- Sponsor
- Arvinas Inc.
Advanced Malignancies
A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.
- Trial name
- NCT03241173
- Testing
- INCAGN01949, Nivolumab, Ipilimumab
- Where
- 15 sites in United States
- Volunteers
- 52 people
- Sponsor
- Incyte Biosciences International Sàrl
Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung.
- Conditions
- Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer
- Trial name
- NCT05005403
- Testing
- Azirkitug, Budigalimab, Bevacizumab
- Where
- 48 sites in United States, Canada and 4 more
- Volunteers
- 694 people
- Sponsor
- AbbVie
Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC)
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical ([225Ac]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors…
- Conditions
- Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer
- Trial name
- NCT07020117
- Testing
- [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
- Where
- 14 sites in United States
- Volunteers
- 150 people
- Sponsor
- Aktis Oncology, Inc.
Castration-Resistant Prostate Cancer (CRPC), Colorectal Cancer
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
This is a Phase 1/2a dose escalation and expansion study to determine the safety, tolerability, and preliminary clinical activity of 177LuBetaBart, a lutetium-labeled anti-B7-H3 monoclonal antibody, in patients with…
- Conditions
- Castration-Resistant Prostate Cancer (CRPC), Colorectal Cancer, NSCLC (Non-small Cell Lung Cancer), Ovarian Cancer
- Trial name
- BetaBart (NCT07189871)
- Testing
- 177Lu-BetaBart, BetaBart + unlabeled BetaBart
- Where
- 5 sites in United States
- Volunteers
- 61 people
- Sponsor
- Radiopharm Theranostics, Ltd
Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)
- Trial name
- ELUCIDATE (NCT05985655)
- Testing
- GTAEXS617, SoC
- Where
- 15 sites in United States, Belgium and 1 more
- Volunteers
- 230 people
- Sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Breast Cancer, TNBC - Triple-Negative Breast Cancer
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer.
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT06568692
- Testing
- PCS6422 and capecitabine, Capecitabine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Processa Pharmaceuticals
Metastatic Triple-Negative Breast Carcinoma
Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer
Evaluating the combination of the investigational, multi-peptide cancer vaccine PVX-410 in combination with pembrolizumab and chemotherapy in treatment naive patients with metastatic, triple negative breast cancer who are PDL1…
- Trial name
- NCT04634747
- Testing
- PVX-410
- Volunteers
- 53 people
- Sponsor
- OncoPep, Inc.
Triple Negative Breast Cancer, Endometrial Cancer
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors.
- Conditions
- Triple Negative Breast Cancer, Endometrial Cancer, Solid Tumor, Unspecified, Adult, Colorectal Cancer
- Trial name
- NCT04577963
- Testing
- Fruquintinib, Tislelizumab
- Where
- 16 sites in United States
- Volunteers
- 52 people
- Sponsor
- Hutchmed
Neoplasms, Breast
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and…
- Trial name
- ZEST (NCT04915755)
- Testing
- Niraparib
- Where
- 198 sites in United States, Argentina and 25 more
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Advanced or Metastatic Solid Tumors, Triple Negative Breast Cancer (TNBC)
A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors
This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SHY-ONC6 in participants with advanced or metastatic solid tumors…
- Conditions
- Advanced or Metastatic Solid Tumors, Triple Negative Breast Cancer (TNBC), HR+ Breast Cancer, Colon Cancer
- Trial name
- Luca-1 (NCT07705334)
- Testing
- SHY-ONC6
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- SHY Therapeutics
TNBC - Triple-Negative Breast Cancer, Breast Cancer
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or…
- Trial name
- PRESERVE 2 (NCT04799249)
- Testing
- Trilaciclib, Gemcitabine, Carboplatin
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 194 people
- Sponsor
- G1 Therapeutics, Inc.
Solid Tumor
A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors
In phase Ia study, the safety and tolerability of SI-B003 in patients with recurrent or metastatic solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum…
- Trial name
- NCT04606472
- Testing
- SI-B003
- Where
- 8 sites in China
- Volunteers
- 60 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer (Triple Negative Breast Cancer (TNBC))
Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with…
- Trial name
- NCT07487519
- Testing
- HLX43 DOSE 1 IN ≥2L TNBC, HLX43 DOSE 2 IN ≥2L TNBC, HLX43 DOSE 1 + HLX10
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Shanghai Henlius Biotech