Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Apatinib

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants will receive apatinib combined with albumin-bound paclitaxel until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet,QD,Q3W

Apatinib Mesylate

Subjects receive Albumin-Bound Paclitaxel,ivgtt, Strength: 125 mg/m\^2,d1、7、15,Q3W

weiwei Huang

This study is a single-arm,exploratory clinical study, to evaluate the effectiveness and safety of apatinib mesylate combined with albumin-bound paclitaxel for second-line treatment of advanced triple negative breast cancer.

This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to explore that PFS and safety of apatinib combined with albumin-bound paclitaxel for treatment of advanced triple negative breast cancer.

In treatment period, patients will be administrated apatinib plus albumin-bound paclitaxel, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.

The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.

Apatinib Combined With Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer

Apatinib Mesylate Combined With Albumin-bound Paclitaxel for Second-line Treatment of Advanced Triple Negative Breast Cancer:a Single-arm,Exploratory Clinical Study

PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.

Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization.

The OS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.

ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.

The ORR will be reported by percentage with each arms and appropriate confidence intervals.

DCR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR or SD. DCR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR or SD to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.

The DCR will be reported by percentage with each arms and appropriate confidence intervals.

\[Time Frame: From enrollment to 12 month\]

Fujian Cancer Hospital

Antirheumatic Agents

Cyclophosphamide

Sacituzumab govitecan

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunoconjugates

Sacituzumab plus chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK)

Dose: 15 μg/kg subcutaneously (SC)

Frequency: administered on Day 8 of each cycle (every 3 weeks)

N-803

Dose: \~2 × 10\^9 cells intravenously (IV)

Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)

PD-L1 t-haNK

Phase 1b:

Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV) Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV) Dose level -1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV)

Phase 2: Dose based on Phase 1b Recommended Phase 2 Dose (IV)

Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)

Sacituzumab Govitecan-Hziy

Dose: 25 mg capsules taken twice per day by mouth (PO)

Frequency: to be taken Days 1-15 and 15-19 of each cycle (every 3 weeks)

Bobby Reddy, MD

This is a phase 1b/2 open-label study to evaluate the safety and efficacy of sacituzumab govitecan-hziy in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects with Triple Negative Breast Cancer (TNBC) after at least 2 prior treatments for metastatic disease.

In part 1 of phase 1b, 3 to 6 subjects will be sequentially enrolled starting at dose level 1 and will be assessed for dose limiting toxicities (DLTs). Dose level cohorts for sacituzumab govitecan-hziy are as follows:

* Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV)
* Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV)
* Dose level 1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV)

In part 2 of phase 1b, dose expansion will occur when the RP2D has been determined. An additional 4 subjects may be enrolled, for a total of up to 10 subjects at the RP2D. Following part 2 of the phase 1b portion of the study, the Safety Review Committee (SRC) will meet to determine if enrollment into phase 2 should proceed.

In the phase 2 portion of the study, 22 subjects will be enrolled at the RP2D in the first stage of Simon's two stage optimal design. If ≥ 9 of 22 subjects exhibit a confirmed response, the study will proceed to the second stage.

If the study proceeds to the second stage, an additional 41 subjects will be enrolled for a total of 63 subjects in the phase 2. If ≥ 27 of the 63 subjects exhibit a confirmed response, the combination therapy will be considered for further development.

All subjects may receive up to 17 cycles (ie, 51 weeks) of treatment administered in 3-week cycles.

A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies

Open-Label Phase 1b/2 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy

Determine the MTD or HTD and designate a recommended phase 2 dose (RP2D)

Incidence of dose limiting toxicities, treatment-emergent adverse events, and serious adverse events

ImmunityBio, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Small Cell Lung Carcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Mesothelioma

Mesothelioma, Malignant

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms, Mesothelial

Small Cell Lung Cancer

Malignant Mesothelioma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Pembrolizumab

Antibodies

Antibodies, Monoclonal

Vaccines

Poly ICLC

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Interferons

Patients receive CDX-1401, Poly-ICLC and Pembrolizumab for 4 cycles (Q 3 weeks) followed by Pembrolizumab alone (Q 3 weeks) until disease progression.

200mg/kg by IV infusion on Day 1 of each 3 week cycle. Given until disease progression

1mg given subcutaneously on day 1 of each 3 week cycle. Given for 4 cycles

CDX-1401

2mg given subcutaneously on day 1 and 2 of each 3 week cycle. Given for 4 cycles

Poly-ICLC

Vamsidhar Velcheti, MD

This study will look at the safety of the combination of three drugs (CDX-1401, Poly-ICL, and Pembrolizumab) and its effect on decreasing tumors. Pembrolizumab is an experimental cancer drug. CDX-1401 is a tumor specific antigen and Poly-ICL is a Toll-like receptor agonist tumor specific antigens which when combined with Pembrolizumab may increase the tumor response to this drug.

Antigen presentation and cellular immunity are complex processes, and subject to modulation because of the tumor microenvironment. Antigen presenting cells in the tumor microenvironment acquire the antigens from tumor cells. Tumors express several tumor specific antigens that can be leveraged by the immune system to mount an effective anti-tumor response. NY-ESO-1, one of the cancer testis antigens, is expressed in several tumors including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), and melanoma. NY-ESO-1 is highly immunogenic and spontaneous tumor regressions in association with humoral and cellular responses to NY-ESO-1 have been reported. NY-ESO-1 is tumor specific and is not detected in non-malignant tissues with the exception of germ cells and trophoblasts, thus making it an attractive target for cancer vaccine development. Cancer vaccines can augment the process of cancer specific antigen presentation, however the efficacy of protein-based vaccines is limited due to weak immunogenicity and inefficient uptake by antigen presenting cells for presentation to T and B cells, and lack of targeting to appropriate antigen presenting cells. Dendritic cells (DCs) are highly specialized antigen-presenting cells that play a central role in initiating and regulating immunity. Deca-lectin, DEC-205 (CD205) is a surface receptor of DCs, which is highly expressed by human DCs and can mediate antigen uptake, processing, and presentation. CDX-1401 is a fully human anti-DEC-205 mAb (3G9) genetically fused to the full length NY-ESO-1. In preclinical studies, Dec-205 fused to NY-ESO-was more efficiently cross-presented to T-cells than NY-ESO-1 protein alone. In a recently concluded phase 1 study of CDX-1401 in combination with adjuvant Toll-like receptor agonists with Resiquimod (TLR7/8 agonist) and Hiltonol (poly-ICLC; TLR3 agonist), CDX-1401 was well tolerated with no dose-limiting toxicities and no treatment related grade 3/4 toxicities. Clinical activity was noted in solid tumors including NSCLC. Interestingly, few of the patients who progressed on CDX-1401 subsequently received immune checkpoint inhibitors and several of these patients with NY-ESO-1-specific cellular response had partial responses by RECISTimmune-related response criteria (IRRC). Previous studies reported enhanced T-cell responses in autologous dendritic cell/myeloma fusion vaccines with PD-1 blockade using CT-011 (Anti-PD1 antibody). In addition, increased tumor-infiltrating dendritic cells which are PD1 positive mediate immune suppression and PD-1 blockade in mice ovarian cancer models enhance effector T-cell responses and reduce tumor burden. Thus, we hypothesize that the ability of CDX-1401 to generate an effective anti-tumor immune response could be enhanced when co-administered with an anti-PD1 antibody.

In this study, investigators will examine the safety of the three drug combination of CDX-1401, Poly-ICL (TLR-3 agonist), and Pembrolizumab, and its impact in generating robust and effective anti-tumor immune responses. The preliminary clinical data from Pembrolizumab are promising, and strategies such as this to enhance tumor specific antigen presentation may augment the responses and clinical benefit from Pembrolizumab.

Primary Objective:

To assess the safety, and tolerability of CDX-1401 in combination with Pembrolizumab

Secondary Objectives:

1. To determine whether the anti-tumor response is substantially increased by vaccination with CDX-1401 (anti-DEC205-NY-ESO-1 fusion protein vaccine) in combination with an immune-checkpoint inhibitor, Pembrolizumab (anti-PD1 mAb) in previously treated patients with advanced solid tumors.
2. To determine immune response to NY-ESO-1 and other tumor specific antigens in patients treated with CDX-1401 and Pembrolizumab.
3. To evaluate changes in Tumor infiltrating lymphocytes and other immune evasive pathway biomarkers post treatment with CDX-1401 and Pembrolizumab.
4. To perform exploratory analysis to identify biomarkers to predict both antigen specific T-cell responses and clinical benefit to CDX-1401 and Pembrolizumab.

A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

A Phase I/II Trial of CDX-1401 (a Vaccine Consisting of a Human Monoclonal Antibody Specific for DEC-205, Fused to Full-length Tumor Antigen NY-ESO-1) in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

Dose limiting toxicity (DLT) will be defined as any side effects which are attributable to the study treatment during the first 28 days of therapy (Cycle 1). The dose limiting toxicity will be based on the tolerability observed during treatment.

Tumor response will be assessed using immune-related Response Criteria (irRC). The objective response rate will be estimated based on the crude proportion of patients who achieve complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Partial response is defined as \>=50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.

Tumor response will be assessed using immune-related Response Criteria (irRC). The duration of response will be calculated from the time when the criteria for response are first met to the first documentation of relapse (after CR) or progression (after PR). Complete response is defined as the disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Partial response is defined as \>=50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart. Stable disease is when 50% decrease in tumor burden compared with baseline cannot be established nor 25% increase compared with baseline. Progressive disease is defined as at least 25% increase in tumor burden compared with baseline in two consecutive observations at least 4 weeks apart.

Tumor response will be assessed using immune-related Response Criteria (irRC). Complete response is defined as the disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Partial response is defined as \>=50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart. Stable disease is when 50% decrease in tumor burden compared with baseline cannot be established nor 25% increase compared with baseline. Progressive disease is defined as at least 25% increase in tumor burden compared with baseline in two consecutive observations at least 4 weeks apart.

Time from beginning of treatment to disease progression. Progressive disease is defined as at least 25% increase in tumor burden compared with baseline in two consecutive observations at least 4 weeks apart.

Defined as time from beginning of treatment until death, withdrawal of consent, or the end of the study, whichever occurs first.

Case Comprehensive Cancer Center

Carboplatin

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Carboplatin AUC 4 every 3 weeks IV infusion plus daily oral everolimus 5mg pill

Carboplatin will be administered if ANC \> 1.0 and platelets are \>75k

The study drug Everolimus will be self-administered (by the patients themselves).

Amy Tiersten, MD

The purpose of this study is to evaluate the safety and effectiveness of carboplatin compared to the combination of carboplatin and everolimus for the treatment of advanced triple-negative breast cancer (TNBC).

Study close to accrual

Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer

A Multi-Centered Randomized Phase II Study Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer

The time from the date of randomization to confirmed disease progression or death from any cause, whichever occurs first.

Overall Response by RECIST 1.1. the best response recorded from the start of the study treatment until the end of treatment.

The time from the date of randomization to death from any cause.

The best overall response rate including complete response (CR) + partial response (PR) + stable disease (SD) \>= 6 months.

Novartis

amy tiersten

Associate Professor

In the escalation study, the minimum initial dose was 5.0×10\^6 cells, then increased to 5.0×10\^7 and 2.0×10\^8 cells. The infusion is given every 2 weeks.

SZ011 CAR-NK

Jing Lin, PhD

This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ011 in the treatment of advanced triple-negative breast cancer.

Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Advanced Triple Negative Breast Cancer

To evaluate the safety of SZ011 CAR-NK Cells

To evaluate the ORR of SZ011 CAR-NK Cells

To determine the anti-tumor effectivity of SZ011 CAR-NK Cells

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Apatinib Combined With Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer	NCT05019690	Advanced Triple...	Apatinib Mesyla... Albumin-Bound P...	18 Years - 75 Years	Fujian Cancer Hospital
A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies	NCT04927884	Advanced Triple...	N-803 PD-L1 t-haNK Sacituzumab Gov... Cyclophosphamid...	18 Years -	ImmunityBio, Inc.
A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients	NCT02661100	Non Small Cell ... Advanced Triple... Small Cell Lung... Urothelial Canc... Mesothelioma Malignant Melan...	Pembrolizumab CDX-1401 Poly-ICLC	18 Years -	Case Comprehensive Cancer Center
Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer	NCT02531932	Breast Cancer	Carboplatin Everolimus	18 Years -	Icahn School of Medicine at Mount Sinai
Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Advanced Triple Negative Breast Cancer	NCT05686720	Advanced Triple...	SZ011 CAR-NK	18 Years - 80 Years	First Affiliated Hospital of Shantou University Medical College
A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies	NCT04927884	Advanced Triple...	N-803 PD-L1 t-haNK Sacituzumab Gov... Cyclophosphamid...	18 Years -	ImmunityBio, Inc.
Apatinib Combined With Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer	NCT05019690	Advanced Triple...	Apatinib Mesyla... Albumin-Bound P...	18 Years - 75 Years	Fujian Cancer Hospital

Spots Global Cancer Trial Database for advanced triple negative breast cancer