Clinical Trials for Breast Cancer

A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in 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: This trial enrolls adults with unresectable, locally advanced or metastatic solid tumors expressing Nectin-4 who have progressed after or are ineligible for standard systemic therapy, excluding those with brain metastases or serious comorbidities. Patients receive IPH4502, a novel antibody-drug conjugate targeting Nectin-4 with an exatecan payload, administered as monotherapy.

ClinicalTrials.gov ID: NCT06781983

Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in 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: Eligible patients are adults with advanced, refractory solid tumors (including soft-tissue sarcoma, triple-negative breast cancer, NSCLC, cervical cancer, ovarian cancer, or KRAS-mutant pancreatic ductal adenocarcinoma), who have not previously received anthracyclines. The trial investigates Spedox-6, a novel human serum albumin-encapsulated doxorubicin formulation designed to enhance tumor delivery and reduce cardiotoxicity, given IV every 21 days at escalating doses (with filgrastim support at higher doses).

ClinicalTrials.gov ID: NCT07064018

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

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 advanced solid tumors—including HNSCC, NSCLC, GI, GU, gynecologic, sarcoma, neuroendocrine, and NUT carcinoma—who have measurable disease and good performance status, to evaluate the intravenous BRD4 degrader MT-4561 administered weekly. MT-4561 is a novel agent targeting BRD4 for ubiquitin-mediated degradation and is being assessed primarily for safety and initial efficacy in this biomarker-unselected population.

ClinicalTrials.gov ID: NCT06943521

A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing 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 advanced, relapsed or refractory HER3-expressing solid tumors (including cutaneous melanoma, EGFR-mutant NSCLC, and HR+/HER2- breast cancer) who have progressed following or are ineligible for standard therapies. Patients receive intravenous ENV-501, a HER3-targeting antibody-drug conjugate designed to deliver a cytotoxic payload selectively to HER3-expressing tumor cells.

ClinicalTrials.gov ID: NCT06956690

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

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: Enrolling adults with locally advanced or metastatic epithelial cancers (including multiple breast cancer subtypes, NSCLC, cervical, prostate, pancreatic, head and neck, endometrial, ovarian, gastric/GEJ, or urothelial carcinomas) who have progressed after ≥2 prior therapies and lack standard options, this study delivers IV DR-0202, a bispecific antibody targeting CLEC7A on myeloid cells and a tumor-associated antigen, aiming to activate myeloid-driven phagocytosis and antitumor immunity.

ClinicalTrials.gov ID: NCT06999187

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally 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.

HealthScout AI summary: This trial is enrolling adults with previously treated, locally advanced or metastatic solid tumors (including urothelial carcinoma and other Nectin-4–positive types) who have measurable disease and good performance status. Patients receive [225Ac]Ac-AKY-1189, an investigational Nectin-4–targeting radiopharmaceutical that delivers actinium-225 directly to tumor cells, in up to six cycles following Nectin-4 PET imaging confirmation.

ClinicalTrials.gov ID: NCT07020117

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M17D1 in Subjects With HER2-Expressing or HER2-Mutant 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.

HealthScout AI summary: This trial enrolls adults with unresectable, locally advanced, or metastatic HER2-positive or HER2-mutant solid tumors (including but not limited to breast, gastric/GEJ, NSCLC, endometrial, ovarian, and urothelial cancers) who have progressed on or are not candidates for standard therapy. Patients receive BL-M17D1, an investigational HER2-targeted antibody-drug conjugate, given intravenously on Days 1 and 8 of a 21-day cycle.

ClinicalTrials.gov ID: NCT06714617

A Phase 1 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-4700 as Monotherapy and in Combination With Pembrolizumab 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors—including specified types such as head and neck squamous cell carcinoma, melanoma, NSCLC, cervical, triple negative breast, urothelial, and renal cell carcinoma—who have progressed after standard therapy or lack standard options, to receive the investigational agent MK-4700 (mechanism of action undisclosed) as monotherapy or in combination with the PD-1 inhibitor pembrolizumab. Key exclusions include active CNS metastases, significant comorbidities, or recent organ transplants.

ClinicalTrials.gov ID: NCT06894771

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers

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 solid tumors (mainly gastric, non-small cell lung, triple-negative breast, and cervical cancers) expressing KK-LC-1 and positive for HLA-A*01:01, who have exhausted standard therapies, receive lymphodepleting chemotherapy followed by a single infusion of autologous T cells engineered to express a T cell receptor targeting the KK-LC-1 antigen, plus aldesleukin. This trial investigates the safety and dosing of this KK-LC-1-specific TCR-T cell therapy.

ClinicalTrials.gov ID: NCT05483491

A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies 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: This trial enrolls adults with advanced solid tumors harboring activating PIK3CA mutations who have progressed after standard therapy, including a cohort specifically for HR+/HER2- advanced breast cancer with prior CDK4/6 inhibitor and anti-estrogen exposure. Patients receive ETX-636, an oral, mutant-selective PI3Kα inhibitor and degrader, either as monotherapy or combined with fulvestrant.

ClinicalTrials.gov ID: NCT06993844