Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Prostatic Neoplasms

Breast Neoplasms

Triple Negative Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Melanoma

Carcinoma, Transitional Cell

Ovarian Cancer

Ovarian Epithelial Cancer

Transitional Cell Carcinoma

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Analgesics

Antibodies

Antibodies, Monoclonal

Aldesleukin

Immunomodulating Agents

Nivolumab

Immunoglobulins

Interleukin-2

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Single dose of NeoTCR-P1 plus nivolumab 480mg IV every four weeks for up to 6 doses.

Single dose of NeoTCR-P1 plus IL-2 500,000 IU/m2 SC twice daily (BID) for 7 days.

The investigational agent in this protocol is NeoTCR P1, an autologous adoptive T cell therapy (ACT) for patients with solid cancer. NeoTCR P1 is composed of apheresis derived CD8 and CD4 T cells that are precision genome engineered to express one autologous TCR of native sequence that targets a neoepitope (neoE) presented by human leukocyte antigen (HLA) receptors exclusively on the surface of that patient's tumor cells and not on other cells in the body.

NeoTCR-P1 adoptive cell therapy

Nivolumab is a human IgG4 anti-PD-1 monoclonal antibody

nivolumab

IL-2 is a biologic response modifier. It is a type of protein called a cytokine.

IL-2

This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.

A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors

Dose limiting toxicity (DLT) is defined as protocol-defined adverse events that occur within 28 days following infusion of Neo-TCR-P1 administered as a single agent without or with IL-2, or in combination with nivolumab.

Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Cytokine release syndrome (CRS) and neurotoxicity associated with NeoTCR-P1 will be graded according to ASBMT consensus grading.

The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.

Percent of screened patients that enroll on study and receive NeoTCR-P1

ORR will be defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1, as determined by the investigator

Duration of response, defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause

PFS is defined from date of administration of NeoTCR-P1 cell infusion to the date of disease progression per the RECIST v1.1 or death as a result of any cause. Subjects who do not meet criteria for progression by the analysis data cut-off date will be censored at their last evaluable disease assessment date

OS will be measured from the date of administration of NeoTCR-P1 to the date of death. Subjects who have not died by the analysis data cut-off date will be censored at their last date of contact.

PACT Pharma, Inc.

Infections

Virus Diseases

Breast Diseases

Skin Diseases

Trastuzumab

Atezolizumab

Letrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

HR+/HER2-neg patients who will receive pelareorep plus letrozole

HR+/HER2-neg patients who will receive pelareorep plus letrozole plus atezolizumab

TNBC patients who will receive pelareorep plus atezolizumab

HER2+/HR+ patients who will receive pelareorep plus trastuzumab plus atezolizumab

HER2+/HR- patients who will receive pelareorep plus trastuzumab plus atezolizumab

HER2+ (irrespective of HR status) (6 patients) who will receive pelareorep + trastuzumab

4.5 × 10e10 TCID50 administered intravenously on Days 1, 2, 8 \& 9

Pelareorep

Oral dose of 2.5 mg/day starting on Day 3 for 13 days

1200 mg administered intravenously on Day 3

8mg/kg administered intravenously or 600mg subcutaneously on Day 3

The purpose of this study is to find out if pelareorep in combination with different therapies helps to reduce the growth of breast cancer cells and increase the immune system's response to cancer. This study will also help to understand what this treatment does to the tumor. In addition, the safety of the combination treatments with pelareorep will be evaluated.

This is a window of opportunity non-randomized exploratory study to evaluate the safety and anti-tumor immunogenicity of pelareorep -/+ atezolizumab in five different cohorts in women with operable early breast cancer.

After enrollment, pelareorep will be administered at 4.5 × 1010 TCID50 intravenously on days 1, 2, 8 \& 9. Other therapies will be administered according to the assigned treatment cohort.

After an initial biopsy (diagnostic biopsy in most cases), a second biopsy will be performed on Day 3. Patients will continue the planned treatment until day 21(±5), when a third biopsy will be performed. This third biopsy can be the surgical specimen if patient was scheduled for primary surgery, or a core biopsy if patient will undergo neoadjuvant treatment.

Blood samples will be collected throughout the study at three time points, Day 1, Day 3, and End of Treatment.

Patients will receive treatment for 3 weeks prior to surgery or neoadjuvant therapy. Thereafter, patients will either be considered for definitive surgery or primary medical treatment (e.g. neoadjuvant chemotherapy) at the discretion of the treating physician. Surgery or biopsy prior to neoadjuvant chemotherapy should be done within 3 weeks (±5 days) from the start of the study treatment.

The end of study visit will be performed at the day of surgery. A safety follow-up, the end of study visit, will be done at 28 days (± 7 days) after the last dose of treatment received

A Window-of-opportunity Study of Pelareorep in Early Breast Cancer

A Window-of-opportunity Study of Pelareorep in Early Breast Cancer (AWARE-1)

CelTIL score is a metric for quantifying broad changes to the tumor microenvironment and is calculated by the following equation:

CelTIL score = -0.8 × tumor cellularity (in percent) + 1.3 × TILs (in percent). The minimum and maximum unscaled CelTIL scores will be -80 and 130. This unscaled CelTIL score will then be scaled to reflect the reported values ranging from 0 to 100 points where an increase in CelTIL scores represent favorable changes to the tumor microenvironment.

SOLTI Breast Cancer Research Group

Oncolytics Biotech

Paclitaxel

Albumin-Bound Paclitaxel

Avelumab

Tubulin Modulators

Antimitotic Agents

Patients receive pelareorep + paclitaxel.

Patients receive pelareorep + paclitaxel + avelumab.

Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.

Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.

Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.

The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy \[paclitaxel\] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 negative(HER2-) breast cancer, which is either locally advanced or has metastasized (cancer that has spread in your body). The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone, or pelareorep and paclitaxel. The safety of the combination treatments will also be evaluated.

This is an open-label randomized Phase 2, 3-cohort study to evaluate the safety and efficacy of pelareorep, paclitaxel and avelumab in Hormone Receptor+ (HR+)/Human Epidermal Growth Factor Receptor 2 negative (HER2-) with endocrine-refractory metastatic breast cancer.

Patients will be randomized to one of three treatment cohorts: paclitaxel alone, pelareorep + paclitaxel, or pelareorep + paclitaxel + avelumab. A three patient safety run-in will be conducted in the cohort for pelareorep + paclitaxel + avelumab prior to beginning randomization into all three cohorts.

Patients will give mandatory blood samples and optional tumor biopsies, which will be analyzed for biomarkers to determine the immunological changes within the tumor microenvironment and peripheral blood in patients treated with paclitaxel alone, in combination with pelareorep, and in combination with pelareorep and avelumab.

A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study

Assessed by T cell receptor (CDR3 variable chain) sequencing in all patients.

Overall response rate according to RECIST V1.1

Overall Survival assessed at end of study

Overall response rate at week 16 according to RECIST V1.1.

Type, incidence, severity (as graded by the NCI CTCAE v. 5.0), seriousness and attribution to the study medications of AEs and any laboratory abnormalities.

PrECOG, LLC.

Mitogens

Serplulimab

Zhenzhen Liu

Dechaung Jiao

The goal of this clinical trial is to learn if serplulimab is effective in early HR+/HER2- breast cancer. It will also learn about the safety of serplulimab. The main questions it aims to answer are:

Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature.

Participants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 3 cycles.

In recent years, significant progress has been made in the immunotherapy of breast cancer, and PD1/PDL1 inhibitors have achieved good results in the treatment of triple-negative breast cancer. There have also been many attempts to apply them in HR+/HER2- breast cancer. In the I-SPY2 study, Pembrolizumab combined with chemotherapy increased the pCR rate of HR+/HER2- breast cancer from 13% in the chemotherapy alone group to 30%. In the KEYNOTE756 study, Pembrolizumab in combination with chemotherapy increased the pCR rate by 8.5% (24.3% vs. 15.6%) compared to the chemotherapy-only arm in HR+/HER2- breast cancer. pCR rates in the navulizumab arm of the CheckMate 7FL study were 24.5% compared with 13.8% in the control arm. While further long-term follow-up data are still needed to confirm patient benefit, it still provides a new treatment option for HR+/HER2- breast cancer patients.

The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.

The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer

Serplulimab Plus Chemotherapy for Early-stage ER+/HER2- Breast Cancer

Phase II Study Serplulimab Combined With Neoadjuvant Chemotherapy for Early-stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer

After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)

EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause.

Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause

DDFS is defined as the time from surgery to distant recurrence or death from any cause

ORR is defined as the number of target lesion responders as assessed by MRI

Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0

Henan Cancer Hospital

Patritumab deruxtecan

All participants included in the study who answer the eligibility criteria will receive a starting dose of 5.6 mg/kg of U3-1402 every 3 weeks until progression or until unacceptable toxicity

First infusion for 90 minutes and then infusion duration can be progressively decreased to 30 minutes if participant doesn't experience infusion related reactions (IRR)

U3-1402

Barbara Pistilli, Dr

Fernanda Mosele, Dr

Ghada Nachabeh, PM

Barbara Pistili, Dr

This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors. Participants may have received multiple lines of endocrine therapy with or without targeted therapies and must have received only one line of chemotherapy for ABC.

Moreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated.

A total of 100 participants are planned to be treated in the study. Participants will receive, every three weeks, a dose of U3-1402 equivalent to 5.6 mg/kg of body weight until progression or until unacceptable toxicity.

Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and/or bone CT scans will be also performed throughout the study for participants with brain and/or bone metastasis.

The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events.

One group of 100 participants receiving U3-1402 (around 170 enrolled with an estimation rate of 70% of screen failures)

Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer

Phase 2, Open Label Study of Patritumab Deruxtecan (U3-1402), an Anti-HER3-Antibody Drug Conjugate (ADC), in Patients With Advanced Breast Cancer, With Biomarker Analyses to Characterize Response to Therapy

Defined as the proportion of participants who achieved a confirmed complete response (CR) or partial response (PR) assessed by investigators

Applicable to participants with either complete response (CR) or partial response (PR) and is defined as the time from the first documented CR or PR until the date of disease progression, or until the date of death. It will be evaluated in the overall population and in subgroups of patients according to their HER3 expression levels

Defined as the time date of the first dose until progression or death from any cause, whichever occurs first. It will be evaluated in the overall population and in subgroups of patients according to their HER3 expression levels

Defined as the presence of at least a PR or CR, or a stable disease (SD) for more than six months under treatment. It will be evaluated in the overall population and in subgroups of patients according to their HER3 expression levels

Defined as the proportion of participants who achieved a confirmed complete response (CR) or partial response (PR) assessed by investigators and will be linked to the levels of HER3 expression

Defined as the time from date of first dose until death.It will be evaluated in the overall population and in subgroups of patients according to their HER3 expression levels

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors	NCT03970382	Solid Tumor	NeoTCR-P1 adopt... nivolumab IL-2	18 Years -	PACT Pharma, Inc.
A Window-of-opportunity Study of Pelareorep in Early Breast Cancer	NCT04102618	Breast Cancer	Pelareorep Letrozole Atezolizumab Trastuzumab	18 Years -	Oncolytics Biotech
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study	NCT04215146	Breast Cancer M...	Paclitaxel Pelareorep Avelumab	18 Years -	Oncolytics Biotech
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study	NCT04215146	Breast Cancer M...	Paclitaxel Pelareorep Avelumab	18 Years -	Oncolytics Biotech
Serplulimab Plus Chemotherapy for Early-stage ER+/HER2- Breast Cancer	NCT06394661	Breast Cancer	Serplulimab	18 Years -	Henan Cancer Hospital
Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer	NCT04965766	Metastatic Brea...	U3-1402	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris

Spots Global Cancer Trial Database for hr+ breast cancer