Clinical Trials for Breast Cancer

Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease

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.

HealthScout AI summary: This trial enrolls adults with HER2-positive breast cancer and confirmed leptomeningeal disease (with or without brain metastases), who will receive radiation therapy followed by intrathecal trastuzumab (HER2-targeted antibody) and dose-escalated intrathecal pertuzumab (HER2 dimerization inhibitor) via an Ommaya reservoir. Patients must have adequate organ function and the ability to undergo Ommaya placement; prior therapies are allowed.

ClinicalTrials.gov ID: NCT04588545

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally Advanced/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.

HealthScout AI summary: This trial enrolls adults with unresectable locally advanced or metastatic solid tumors—including colorectal, triple-negative breast, melanoma, and ovarian cancer—who have progressed on or cannot receive standard therapies, to receive NM1F (a PVRIG/CD112R immune checkpoint inhibitor) alone or in combination with pembrolizumab. Key exclusions are active CNS involvement, prior PVRIG/CD226-axis therapy, and significant comorbidities.

ClinicalTrials.gov ID: NCT05746897

A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced 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.

HealthScout AI summary: Adults with advanced solid tumors receive first-in-human BMS-986500 monotherapy (with a dedicated expansion for CCNE1-amplified ovarian cancer); separate cohorts enroll advanced breast cancer previously treated with a CDK4/6 inhibitor to receive BMS-986500 combined with palbociclib plus fulvestrant. BMS-986500’s molecular target/mechanism is undisclosed; the study focuses on safety/PK and dose finding with exploratory efficacy by RECIST.

ClinicalTrials.gov ID: NCT06997029

Phase Ia/Ib Open Label, Multi-Centre Dose Escalation Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy in Participants With Advanced 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.

HealthScout AI summary: Adults with advanced/metastatic breast, ovarian, or prostate cancer (including patients with known brain metastases), ECOG 0–1, and measurable disease receive oral DSB2455, a PARP1‑selective inhibitor aiming to exploit synthetic lethality in HR‑deficient tumors (e.g., BRCA/HRR alterations); prior first‑line PARP inhibitor exposure is allowed, but prior PARP1‑selective therapy is excluded. Single‑arm dose escalation/expansion evaluates safety and preliminary activity, with CNS penetration highlighted and mandatory biopsies required.

ClinicalTrials.gov ID: NCT06458712

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

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.

HealthScout AI summary: Adults with metastatic or unresectable solid tumors harboring AKT/PI3K/PTEN pathway alterations (excluding concurrent EGFR/KRAS/NRAS/HRAS/BRAF drivers) receive the investigational AKT-pathway inhibitor TER-2013 as monotherapy (expansion in ovarian/cervical/SCCHN/lung/esophageal and endometrial cancers) or with fulvestrant for HR+/HER2- breast cancer previously treated with an aromatase inhibitor. Prior AKT/PI3K/PTEN inhibitors (and prior SERD/mTOR in combo expansion) are excluded; requires ECOG 0–1 and adequate organ function.

ClinicalTrials.gov ID: NCT07109726

A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients 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.

HealthScout AI summary: Adults with advanced solid tumors harboring AKT1 E17K mutations, including a cohort with HR+/HER2- metastatic breast cancer, receive the oral selective AKT1 E17K allosteric inhibitor ATV-1601 as monotherapy or in combination with fulvestrant. The trial excludes tumors with activating RAS/BRAF mutations and aims to identify dosing and preliminary activity while minimizing AKT2-related metabolic toxicities.

ClinicalTrials.gov ID: NCT07038369

An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression

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.

HealthScout AI summary: Adults with incurable, locally advanced/metastatic Nectin-4–positive solid tumors—emphasizing relapsed/refractory urothelial cancer—receive RNDO-564 weekly as monotherapy or combined with pembrolizumab every 3 weeks. RNDO-564 is a fully human CD28 × Nectin-4 costimulatory bispecific antibody intended to deliver localized CD28 T‑cell costimulation at Nectin-4–expressing tumors; early cohorts include multiple Nectin-4–associated cancers, with randomized dose-optimization in urothelial cancer.

ClinicalTrials.gov ID: NCT07218003

A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult 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.

HealthScout AI summary: Adults with advanced solid tumors refractory to standard therapy (ECOG 0–1, measurable disease) receive a single intravenous infusion of IDOV-Immune (VM-002), a genetically engineered oncolytic vaccinia virus designed for tumor-selective replication and lysis with immune-stimulating transgenes to enhance antitumor immunity. Key exclusions include prior oncolytic virus therapy, recent vaccinia/smallpox vaccination, active autoimmune disease requiring systemic therapy, significant cardiopulmonary disease, uncontrolled infection, and unstable/untreated CNS metastases.

ClinicalTrials.gov ID: NCT06910657

A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

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.

HealthScout AI summary: Adults with advanced/metastatic FAP-expressing solid tumors (including pancreatic, multiple breast cancer subtypes, platinum-resistant/refractory ovarian, and other FAP-positive GI tumors) and ECOG 0–1 receive intravenous LY4337713, a lutetium-177–labeled small-molecule radioligand targeting fibroblast activation protein on cancer-associated fibroblasts to deliver beta radiation to the tumor microenvironment, on Q4–6 week cycles. Expansion cohorts are tumor-specific after dose escalation/optimization.

ClinicalTrials.gov ID: NCT07213791

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, 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.

HealthScout AI summary: Adults with advanced, refractory solid tumors (ECOG 0–1) receive an allogeneic, off‑the‑shelf iPSC‑derived CAR T product (FT836) targeting stress‑inducible MICA/MICB (engineered to reduce antigen shedding) as monotherapy or combined with trastuzumab (HER2), cetuximab (EGFR), and/or paclitaxel. Multi‑arm cohorts assess safety and preliminary activity to establish RP2D for the combination regimens.

ClinicalTrials.gov ID: NCT07216105