Triple-Negative Breast Cancer (TNBC)

This study is a phase I/II open-label randomized clinical trial to examine whether administration of isunakinra (EBI-005), a modified recombinant IL1 receptor antagonist, can sensitize human TNBC to the PD1 inhibitor-pembrolizumab-based neoadjuvant chemotherapy (NAC/P) by changing the tumor microenvironment (TME) via reducing the recruitment of immunosuppressive tumorassociated macrophages (TAMs) and increasing activated cytotoxic T-lymphocytes (CTLs).

This study is designed to establish the safety of the combination of PD-1 inhibitor tislelizumab, an anti-angiogenic agent bevacizumab and a chemotherapeutic agent capecitabine, in a phase Ib setting and to evaluate preliminary efficacy in selected expansion cohorts, including PD-L1-negative metastatic triple negative breast cancer (TNBC) and patients with active CNS disease. A sequential approach to cohort expansion will allow further evaluation in hormone receptor positive (HR+), HER2 negative (HER2-) disease if a signal of activity is observed in PD-L1 negative TNBC.

The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \[68Ga\]Ga-DFC413, and in Part 2 compare to \[68Ga\]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \[68Ga\]Ga-DFC413 and \[68Ga\]Ga-NNS309), not all indications might be explored.

This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC). ITI-5000 is a self-amplifying RNA (saRNA) vaccine that instructs the immune system to recognize and attack cancer cells expressing two proteins found on TNBC cells-HERV-K and CT83-fused with a molecule called LAMP-1 that helps the immune system respond more strongly. The vaccine is delivered inside lipid nanoparticles (LNPs), similar to other approved mRNA vaccines. The study has two parts: * Part A: Participants receive ITI-5000 alone at one of two dose levels (1 µg or 10 µg), given as an injection into the upper arm muscle every 28 days for 3 doses total. The goal is to find the safest dose. * Part B: Participants receive ITI-5000 at the best dose identified in Part A, combined with an approved immunotherapy drug called pembrolizumab (Keytruda®), every 21 days for 3 doses total.

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 amplification). Main questions to answer include: * What is the recommended dose for expansion and/or Phase 2, for both monotherapy and in combination with ET * What medical issues/symptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET

This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the BLIS subtype. A total of 140 patients are planned to be enrolled.

This is a first-in-human, multicenter, open-label Phase I/II study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of oral Zn-Telomir monotherapy in adults with advanced or metastatic triple-negative breast cancer. Phase I uses a modified 3+3 dose-escalation design to determine safety, tolerability, maximum tolerated dose, and recommended Phase II dose. Phase II uses a Simon two-stage expansion design at the recommended Phase II dose to evaluate preliminary antitumor activity, including objective response rate per Response Evaluation Criteria in Solid Tumors.

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help monitor and predict treatment responses in patients with breast cancer. The study focuses on patients diagnosed with Stage II to III HER2-positive or Triple-Negative Breast Cancer (TNBC) who are scheduled to receive standard neoadjuvant therapy (systemic treatment administered before surgery). Because these breast cancer subtypes involve different standard treatment regimens, the study prospectively stratifies patients into three distinct treatment cohorts (Cohorts A, B, and C) to match routine clinical practice and align blood sampling with meaningful clinical milestones.

The purpose of this study is to explore the feasibility and acceptability of a nurse-led, coping, and supportive care intervention for patients with triple-negative breast cancer. The intervention aims to improve psychosocial outcomes in patients with triple-negative breast cancer (e.g., quality of life (QOL), anxiety, fear of cancer recurrence (FCR)).

The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.

Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.

The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.

Background: Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer with limited treatment options. Research suggests that using High-Intensity Focused Ultrasound (HIFU) to destroy the tumor and/or PD-1 inhibitor drugs to activate the immune system before starting chemotherapy may improve treatment effectiveness. This study aims to investigate this new approach. Objective: To evaluate the effectiveness and safety of using HIFU, with or without a PD-1 inhibitor (Sintilimab), before and during combination chemotherapy in patients with early-stage TNBC. The primary goal is to determine if this strategy can increase the rate of pathological complete response (pCR). Study Design: This is a single-center, Phase II clinical study. Approximately 40 participants with Stage II-III TNBC will be enrolled and assigned to one of two groups (cohorts) without randomization: Cohort A: Receives HIFU treatment. Two weeks later, begins standard chemotherapy (Abraxane and carboplatin) combined with the PD-1 inhibitor Sintilimab for 6 cycles. Cohort B: Receives HIFU treatment combined with a single dose of the PD-1 inhibitor Sintilimab. Two weeks later, begins the same 6 cycles of chemotherapy (Abraxane and carboplatin) combined with Sintilimab. Main Measures: The primary measure is the rate of pathological complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes after surgery following the completion of neoadjuvant therapy. Other important measures include: The ability of the treatment to activate the immune system (measured by changes in CD8+ T cells or IFN-γ). The percentage of patients whose tumors shrink significantly (Objective Response Rate). How long patients live without their cancer getting worse (Event-Free Survival). The rate of patients who can undergo breast-conserving surgery. The frequency and severity of side effects.

The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are: * Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial/non-response (RCB-I, II, III) to neoadjuvant immunochemotherapy? * Are there specific immune or molecular biomarkers (e.g., TILs, CD3/8/20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.

This is a prospective radiation dose-finding, phase 2 expansion study of the Triple Negative (TN) cohort of the multicenter randomized study P-RAD (A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer; NCT04443348) that seeks to establish the optimal dose of radiation therapy (RT) to elicit an immune response when combined with immune checkpoint inhibitor (ICI) in breast cancer patients. Eligible subjects include women or men with operable, lymph node-positive, triple negative (TN) breast cancer who are candidates for standard of care neoadjuvant chemo-immunotherapy (NAC) based on the KEYNOTE-522 clinical trial. Thirty-two (n=32) patients will be randomized 1:1 to receive either low RT boost (9Gy total) or high RT boost (24Gy total). All RT will be delivered to the intact breast tumor in 3 daily fractions over 3 days. In the Neoadjuvant Phase, the first cycle (C1) of pembrolizumab (200 mg i.v.) will be administered within 0-2 days of initiating RT. Participation in this study requires availability of residual diagnostic tissue biopsies of the primary tumor and metastatic lymph node for research use. If this tissue is not available, baseline research biopsies will be performed. Additionally, a research biopsy of the breast tumor and lymph node is required on Day 10-14 of C1 of pembrolizumab. After completion of the research biopsy in Week 2, the participants can commence standard-of-care neoadjuvant chemotherapy and pembrolizumab at the discretion of their medical oncology provider. After completing NAC, participants will undergo standard of care surgical resection of the breast and axillary lymph nodes, at the discretion of their surgical oncology provider. In the Adjuvant Phase, participants will receive standard of care adjuvant systemic therapy and standard of care adjuvant radiotherapy (if indicated), although recognizing that the breast tumor boost portion of this treatment has already been administered preoperatively. Except for late radiation adverse reactions of special interest, which will be followed yearly for up to 5 years, follow-up will occur every 6 months for 3 years.

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.

This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays. The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC. Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.

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 and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.

This is a Phase 1a/1b, first time in human (FTIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, and preliminary efficacy of CT-202 (study drug), a humanized T cell engaging bispecific antibody targeting nectin-4, in participants with nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant TNBC, CRC, or UC. Results of the study including PK, PD, efficacy, and safety will be used in the RP2D determination.

This study aims to collect information about the effects of chemotherapy combined with immunotherapy (immune checkpoint inhibitors) for early-stage triple-negative breast cancer (TNBC) on ovarian function and fertility. You may be eligible for this study if you have been diagnosed with early-stage TNBC and are planning to receive neoadjuvant chemotherapy combined with immunotherapy before surgery. Additional eligibility criteria apply. Participants who choose to enroll will be asked to complete questionnaires and provide blood samples before and after treatment to measure hormone levels related to ovarian function. Information about menstrual patterns, fertility preservation discussions, and reproductive health will also be collected. Some participants may undergo ultrasound assessments to evaluate ovarian reserve and endometrial thickness. Follow-up will continue for up to 24 months after treatment to assess long-term ovarian function. No additional or experimental cancer treatments will be provided as part of this study. This is an observational study only, and participants will receive standard cancer treatment as recommended by their treating team. It is hoped this research will provide important information about the potential effects of chemotherapy and immunotherapy on ovarian health and fertility in women receiving treatment for early-stage TNBC.

This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs.

EPS101-10-02 is a Phase Ib open label, multicentre clinical trial comprising of a Dose Escalation phase (Part 1) followed by a Dose Expansion phase (Part 2) of MOv18 IgE in patients with folate receptor alpha-expressing (5% or higher) platinum resistant ovarian cancer The dose escalation part of the study will primarily assess the safety and tolerability of MOv18 IgE in ascending dose cohorts, until the determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD). Part 2 (dose expansion) will further assess the safety, tolerability and anti-tumour activity of MOv18 IgE.

The study will evaluate the safety and efficacy of QLC5513 alone or in combination with QL1706 in patients with advanced or metastatic triple-negative breast cancer (TNBC) who had received ≥1 line of prior systematic therapy.

To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer