STK-012 Monotherapy and in Combination Therapy in Patients With Solid Tumors
Recruiting
This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
08/04/2025
Locations: Duke Cancer Center, Durham, North Carolina
Conditions: Advanced Solid Tumor, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Malignant Melanoma, Renal Cell Carcinoma, Cervical Cancer, Microsatellite Instability High, Gastric Cancer, GastroEsophageal Cancer, Urothelial Carcinoma, Mismatch Repair Deficiency, Untreated Advanced NSCLC, 1st Line NSCLC
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Recruiting
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
08/02/2025
Locations: Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina
Conditions: Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
Recruiting
This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/31/2025
Locations: FirstHealth Outpatient Cancer Center, Pinehurst, North Carolina
Conditions: Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers
Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
Recruiting
The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of ORIC-114 as a Single Agent or in Combination with Chemotherapy when administered to patients with advanced solid tumors harboring an EGFR or HER2 alteration.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/31/2025
Locations: Duke Cancer Institute, Durham, North Carolina
Conditions: Solid Tumors
First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
Recruiting
The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/30/2025
Locations: Wake Forest Baptist Health Sciences, Winston-Salem, North Carolina
Conditions: Head Neck Cancer, Metastatic Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Hypopharynx Squamous Cell Carcinoma, Larynx Squamous Cell Carcinoma
Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer
Recruiting
The goal of this phase II study is to test the combination of trilaciclib, pembrolizumab, gemcitabine, and carboplatin in locally advanced unresectable or metastatic triple-negative breast cancer. The main questions it aims to answer are: * to evaluate the anti-cancer efficacy (assess how well it works) * to evaluate the safety and tolerability (how well the body can handle the treatment) of this combination of anti-cancer therapy
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/29/2025
Locations: Levine Cancer Institute, Charlotte, North Carolina
Conditions: Metastatic Triple-Negative Breast Cancer
Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Recruiting
Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer. Livmoniplimab is an investigational drug being developed for the... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/29/2025
Locations: Cone Health Cancer Center /ID# 262583, Greensboro, North Carolina
Conditions: Non-Small Cell Lung Cancer
A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors
Recruiting
CLN-619-001 is a Phase 1, open-label, multi-center study of CLN-619 alone and in combination with pembrolizumab in patients with advanced solid tumors.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/29/2025
Locations: Carolina BioOncology Institute, Huntersville, North Carolina
Conditions: Advanced Solid Tumor, NSCLC
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
Recruiting
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/24/2025
Locations: Local Institution - 0276, Durham, North Carolina
Conditions: Breast Neoplasms
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
Recruiting
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 neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/18/2025
Locations: Research Site, Charlotte, North Carolina +2 locations
Conditions: Breast Cancer
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Recruiting
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/17/2025
Locations: Novant Health, Charlotte, North Carolina +1 locations
Conditions: Carcinoma, Non-small-Cell Lung
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer
Recruiting
The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/17/2025
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
Conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma