Clinical Research Directory

Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer. Participants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.

Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs. Objective: To find a safe dose of metarrestin and to see if this dose shrinks tumors. Eligibility: Adults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options. Design: Participants will be screened with: * blood tests * physical exam * documentation of disease confirmation or tumor biopsy * electrocardiogram to evaluate the heart * review of their medicines and their ability to do their normal activities Participants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary. Participants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body. Adult participants may have tumor biopsies. Participants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.

Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer

The purpose of this study is to evaluate the use of lovastatin, a cholesterol-depleting pro-drug that may lower CAV-1 levels, in order to increase HER2 expression on the cell surface of cancer cells and enhance the uptake and efficacy of trastuzumab deruxtecan (T-DXd) in HER2-low and ultralow breast tumors.

Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer

Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer

This is a single-arm, open-label, phase 2 clinical trial using a stratified Simon minimax two-stage design. The study aims to evaluate the efficacy and safety of low-dose apatinib (250 mg daily) combined with physician-selected single-agent chemotherapy (TPC, capecitabine preferred) in patients with HER2-positive or HER2-low advanced/metastatic breast cancer who progressed after prior ADC therapy (T-DXd or SHR-A1811). Patients are stratified by HER2 status, HR status, lines of prior ADC therapy, and metastasis sites. Approximately 56 patients will be enrolled. The primary endpoint is objective response rate (ORR). Secondary endpoints include PFS1, PFS2, TTP, safety, and OS.

Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort. Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide. The Giredestrant Combination Cohort will evaluate PF-07220060 in combination with giredestrant. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion. In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from Part 1A will be conducted. In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI). In Part 1F, escalating doses of PF-07220060 will be administered in combination with enzalutamide. In Part 1G, PF-07220060 will be administered in combination with tamoxifen to determine the RDE. Part 2A is an expansion cohort for PF-07220060 in combination with fulvestrant and will explore more than one dose of PF-07220060. Part 2B and Part 2C are expansion cohorts for PF-07220060 in combination with letrozole and fulvestrant, respectively. Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. Part 2F is an expansion cohort for PF-07220060 in combination with tamoxifen. The Giredestrant Combination Cohort Group A will determine the tolerable dose of PF-07220060 in combination with giredestrant. In Group B, additional participants will be enrolled at the tolerable dose to further assess safety and PK. The China and Japan monotherapy cohorts will evaluate safety, tolerability, and PK of PF-07220060 as single agent in Chinese and Japanese participants, respectively.

A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors

The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment given to stop the growth of cancer. This study also aims to find the best amount of study medication that can be given to patients. This study is seeking participants with a specific type of breast cancer (BC) called hormone receptor-positive (HR+), HER2- negative (HER2-) breast cancer, or colorectal cancer (CRC) (cancer of the colon or rectum), that has a change (mutation) in a gene called PIK3CA. The cancer must be advanced or metastatic, meaning it has spread to other parts of the body or cannot be completely removed with surgery. All participants in this study will take the study medication (PF-08165784) as a tablet by mouth. The participant may take the medicine at the study clinic during study visits or at home. Treatment will be given in 28-day cycles and will continue for as long as the participant remains in the study. Depending on which part of the study participants are enrolled into, they will receive the study medication (PF-08165784) alone or in combination with other anti-cancer medications.

Albumin-Bound Paclitaxel (Ⅱ) in Patients With Advanced Breast Cancer

This is a multicenter, prospective, observational real-world study. The study aims to evaluate the efficacy, safety and economic benefits of albumin-bound paclitaxel (Ⅱ) compared with conventional albumin-bound paclitaxel, in patients with HER2-negative advanced breast cancer.

Exploring Curative Model for Advanced Breast Cancer: a Single-center, Prospective Phase II Clinical Study

To explore the duration of continued treatment for patients with advanced breast cancer who achieve complete response assessed by PET-CT after receiving systemic anti-tumor therapy.

T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd

This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer

This study is aimed to evaluate the safety and preliminary of all-oral regimen SHR2554 combined with HRS-8080 in advanced breast cancer.

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in PIK3CA-mutated HER2+ Advanced BC (ALPHABET)

Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors

A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer

The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort.

A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors

The purpose of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics (PK) of \[68Ga\]Ga-DWJ155, also known as FKL480, in patients ≥ 18 years of age with advanced gastroesophageal adenocarcinoma (aGEA, where GEA is defined as adenocarcinomas of the distal esophagus, the gastroesophageal junction, and the stomach), hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) advanced breast cancer (aBC), HER2 positive (HER2+) aBC, triple-negative breast cancer (TNBC) and advanced non-small cell lung cancer (aNSCLC) adenocarcinoma.

A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors

This is an open-label, multicenter Phase II study of MHB036C combined with MHB039A in patients with advanced Breast Cancer or other advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MHB036C and MHB039A combination therapy.

Phase II, Prospective, Randomized, Proof-of-concept Study to Evaluate the Effects of a Personalized Dietary Intervention in Women With Advanced Gynecologic or Breast Tumors Treated With Antibody-Drug Conjugates (ADCs).

The objective of the study is to evaluate the effect of a personalized dietary intervention (cohort A), compared with a standard nutritional intervention based on general recommendations for following a Mediterranean diet (cohort B), in women with advanced solid tumors of gynecologic or breast origin who are receiving treatment with antibody-drug conjugates (ADCs). This intervention is exclusively nutritional and does not involve the use of any investigational drug.

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.

Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.

Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer

This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.