Clinical Trials for Breast Cancer

A First-in-Human (FIH), Open-Label, Phase Ia/Ib Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-DP in Participants With Relapsed/Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 adult patients with advanced, relapsed, or treatment-refractory solid tumors—including specific expansion cohorts for breast, pancreatic, ovarian, or colorectal cancer—may receive SON-DP, a first-in-class investigational protein that reprograms malignant cells into normal tissue cells rather than killing them, via IV infusion.

ClinicalTrials.gov ID: NCT05989724

A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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, recurrent, or metastatic solid tumors (including breast, endometrial, and ovarian cancers) who have progressed on standard therapy and meet eligibility criteria are treated with XMT-1660, a B7-H4-targeted antibody-drug conjugate delivering an auristatin payload to B7-H4-positive tumor cells. Prior B7-H4 therapy or auristatin ADCs, untreated CNS metastases, and significant comorbidities are excluded.

ClinicalTrials.gov ID: NCT05377996

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 adult women with ER-positive, HER2-negative advanced breast cancer previously treated with CDK4/6 inhibitors or with metastatic high-grade serous ovarian cancer previously treated with platinum-based chemotherapy. The trial investigates AZD8421, an oral CDK2 inhibitor, as monotherapy or in combination with either camizestrant (oral SERD) or a CDK4/6 inhibitor.

ClinicalTrials.gov ID: NCT06188520

Phase IIa Study Assessing QBS72S For Treating Brain Metastases

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

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

HealthScout AI summary: This trial enrolls adults with relapsed, metastatic CNS disease (either brain metastases or leptomeningeal disease); Cohorts 1 and 2 include breast cancer patients after prior chemotherapy, while Cohort 3 includes patients with leptomeningeal disease from any solid tumor. All participants receive QBS72S, a LAT1-targeted chemotherapeutic agent designed to selectively kill tumor cells with high LAT1 expression, given as monthly IV infusions until progression.

ClinicalTrials.gov ID: NCT05305365

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 (ECOG 0-1, no active CNS metastases) to receive GI-102, a bispecific CD80–IL-2 variant fusion protein designed to selectively activate CD8+ T and NK cells, as monotherapy or combined with standard regimens, including pembrolizumab and trastuzumab deruxtecan (for HER2+ disease).

ClinicalTrials.gov ID: NCT05824975

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 that have progressed on at least three months of pembrolizumab, evaluating the investigational oral integrin αvβ8/αvβ1 inhibitor PLN-101095 as monotherapy or combined with pembrolizumab. Eligible patients must have no other effective treatment options and prior pembrolizumab resistance (primary or secondary).

ClinicalTrials.gov ID: NCT06270706

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 patients with advanced, locally unresectable or metastatic breast cancer of any HER2 status (including HER2-positive, HER2-low, HER2-ultralow, HER2-negative/triple-negative), investigating the combination of BNT323 (a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor) and BNT327 (a bispecific antibody targeting PD-L1 and VEGF-A), with some arms evaluating each agent as monotherapy. Eligible patients are generally pretreated with chemotherapy and must have measurable disease.

ClinicalTrials.gov ID: NCT06827236

A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined with Carboplatin and Pembrolizumab in Patients with Metastatic Triple-negative Breast Cancer (ZAP-IT)

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 metastatic triple-negative breast cancer who have had 1–3 prior chemotherapy regimens (including an antibody-drug conjugate) but have not progressed on prior platinum therapy in the metastatic setting and have not received WEE1 inhibitors; patients receive the investigational WEE1 inhibitor azenosertib combined with carboplatin and pembrolizumab. Azenosertib blocks WEE1 kinase to disrupt cell cycle regulation and enhance DNA damage in tumor cells.

ClinicalTrials.gov ID: NCT06351332

Comparing Oral Drug Dosing Strategies in Older Patients With Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: This trial enrolls patients aged 65 or older with HR+/HER2- metastatic breast cancer who are eligible for combination endocrine therapy plus either palbociclib or ribociclib (CDK4/6 inhibitors), and randomizes them to receive either standard starting doses or lower, titratable doses of the selected CDK4/6 inhibitor. The goal is to determine which dosing approach better maximizes medication tolerance and reduces early discontinuation in this older population.

ClinicalTrials.gov ID: NCT06377852

A Single Arm Phase 1/2 Trial of Abemaciclib + VS-6766 + Fulvestrant in Metastatic HR+/HER2- Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 metastatic or unresectable HR+/HER2- breast cancer that has progressed on prior CDK4/6 inhibitor and fulvestrant therapy, allowing up to two prior chemotherapy lines. Patients receive the investigational dual RAF/MEK inhibitor VS-6766 (which allosterically inhibits both RAF and MEK to overcome resistance), in combination with standard abemaciclib and fulvestrant.

ClinicalTrials.gov ID: NCT05608252