Clinical Trials for Breast Cancer

An Open-label, Multi-center, Phase I/Ib Study of IEV407 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable or metastatic HR-positive/HER2-negative breast cancer previously treated with endocrine therapy plus a CDK4/6 inhibitor receive oral IEV407 alone or with fulvestrant or letrozole. IEV407’s molecular target and mechanism have not been publicly disclosed.

ClinicalTrials.gov ID: NCT07604571

Phase I/II Study of Anti-CD3 x Anti-HER2 Bispecific Antibody (HER2Bi) Armed Fresh Peripheral Blood Mononuclear Cells (HER2 FPBMC) in Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Breast Cancer (MBC)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with ECOG 0–1 and previously treated metastatic castration-resistant prostate adenocarcinoma or metastatic invasive breast cancer receive nine infusions of autologous fresh peripheral blood mononuclear cells armed ex vivo with HER2Bi. This anti-CD3 × anti-HER2 bispecific antibody redirects CD3-positive T cells against HER2-expressing tumor cells without prolonged T-cell expansion.

ClinicalTrials.gov ID: NCT07441889

A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously treated, advanced solid tumors harboring oncogenic PIK3CA mutations, including endometrial, HR-positive/HER2-negative or HER2-low breast, head and neck, gynecologic, and colorectal cancers, receive oral CGT6297. CGT6297 is a mutant-selective, wild-type-sparing allosteric PI3Kα inhibitor with activity against PIK3CA H1047R and potentially E545K mutations.

ClinicalTrials.gov ID: NCT07383506

A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SHY-ONC6 in Participants With Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable advanced or metastatic solid tumors that have progressed on, or are unsuitable or intolerant of, standard therapy receive once-daily oral SHY-ONC6. SHY-ONC6 is a small-molecule proteasome inhibitor targeting selected AAA+ ATPases in the 19S regulatory particle to disrupt ubiquitinated protein processing and promote apoptosis.

ClinicalTrials.gov ID: NCT07705334

A Phase 1/2 Open-Label, Dose Finding and Expansion Study to Investigate the Safety and Effectiveness and Determination of the Optimal Dose of N17350 Administered Intratumorally in Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with refractory unresectable or metastatic solid tumors and an accessible injectable lesion, with expansion cohorts in cutaneous squamous-cell carcinoma, melanoma, head and neck squamous-cell carcinoma, NSCLC, and triple-negative breast cancer. Patients receive intratumoral N17350 every 2 weeks, a recombinant mutant porcine pancreatic elastase targeting the neutrophil elastase/ELANE pathway and designed to induce immunogenic tumor-cell death.

ClinicalTrials.gov ID: NCT07339176

A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DWJ155 and Safety and Imaging Properties of [68Ga]Ga-DWJ155 in Patients With Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced breast, non-small cell lung, gastric/GEJ, or bladder cancer lacking a suitable standard treatment undergo [68Ga]Ga-DWJ155 PET imaging; those eligible then receive intravenous [177Lu]Lu-DWJ155. This investigational HER2-targeted radioligand delivers localized beta radiation to HER2-expressing tumor cells.

ClinicalTrials.gov ID: NCT07660055

A Phase 1/2 Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ARV-6723 Administered as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable or metastatic solid tumors after prior immune-checkpoint or related T-cell-directed therapy and appropriate standard therapy may receive oral ARV-6723 alone or with pembrolizumab. ARV-6723 is an investigational PROTAC that degrades HPK1/MAP4K1 to enhance antitumor immune signaling; later cohorts may include investigator-selected standard of care.

ClinicalTrials.gov ID: NCT07749586

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This study enrolls postmenopausal women with relapsed locally advanced or metastatic AR-positive, ER-positive, HER2-negative breast cancer for whom conventional therapy is unavailable, inappropriate, or declined. Patients receive oral EP0062 (vosilasarm), an investigational selective androgen receptor modulator, as monotherapy in dose-finding or dose-comparison cohorts.

ClinicalTrials.gov ID: NCT05573126

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced or recurrent solid tumors after standard therapy receive intravenous AG01, an investigational antibody targeting progranulin/GP88 to inhibit tumor growth and survival signaling. Expansion cohorts enroll previously treated patients with triple-negative or hormone-resistant breast cancer, non-small-cell lung cancer, or mesothelioma, generally requiring tumor GP88 expression.

ClinicalTrials.gov ID: NCT05627960

A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with previously treated advanced or metastatic solid tumors, ECOG 0–1, measurable disease, and a biopsiable tumor receive intravenous or subcutaneous ST-067, alone, after obinutuzumab pretreatment, or with pembrolizumab. ST-067 is an engineered IL-18 that activates the IL-18 receptor while resisting neutralization by IL-18 binding protein; expansion cohorts focus on melanoma, renal cell, triple-negative breast, non-small cell lung, head and neck squamous cell, and MSI-high cancers.

ClinicalTrials.gov ID: NCT04787042