Clinical Trials for Breast Cancer

An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, and Pharmacokinetics of BTX A51 Alone and in Combination With Fulvestrant in Subjects With Advanced Solid Tumors and Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Metastatic 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.

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 incurable or metastatic solid tumors that have exhausted standard treatment receive oral BTX-A51, an investigational CK1α and CDK7/9 inhibitor. Cohorts with ER-positive, HER2-negative metastatic breast cancer receive BTX-A51 alone or with fulvestrant.

ClinicalTrials.gov ID: NCT04872166

A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

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.

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 relapsed or metastatic solid tumors after standard therapy, including selected breast, ovarian, biliary tract, endometrial, and squamous non-small cell lung cancers, receive AZD8205 alone or in combination with rilvegostomig and/or saruparib. AZD8205 is a B7-H4–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT05123482

A Phase 1 Study of SGN-B6A in Advanced 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.

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 patients with measurable metastatic or unresectable solid tumors and ECOG 0–1, including previously treated patients in monotherapy cohorts and treatment-naive patients with advanced NSCLC, head and neck, or esophageal cancer in combination cohorts. Patients receive sigvotatug vedotin, an integrin β6–targeting antibody–drug conjugate that delivers the microtubule-disrupting payload MMAE, alone or with pembrolizumab, with or without platinum chemotherapy.

ClinicalTrials.gov ID: NCT04389632

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/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.

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 patients with previously treated advanced or metastatic solid tumors, primarily HER2-expressing disease; one cohort permits HER2-null tumors. Patients receive trastuzumab pamirtecan (DB-1303/BNT323), a HER2-directed antibody–drug conjugate carrying a topoisomerase I inhibitor payload, with one cohort also receiving pertuzumab.

ClinicalTrials.gov ID: NCT05150691

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/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.

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 unresectable or metastatic solid tumors, including selected ovarian, endometrial, breast, non-small cell lung cancer, and mesothelioma populations, receive Rina-S alone or with carboplatin, bevacizumab, or pembrolizumab. Rina-S is an investigational FRα-targeting antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT05579366

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced 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.

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 metastatic solid tumors that have progressed after their most recent therapy receive investigational BMS-986340 alone or with nivolumab or docetaxel. BMS-986340 is an anti-CCR8 antibody designed to deplete tumor regulatory T cells.

ClinicalTrials.gov ID: NCT04895709

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor Malignancies

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.

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 measurable, locally advanced or metastatic EGFR-expressing solid tumors who have progressed on or cannot tolerate established therapies receive weekly intravenous JANX008, a protease-activated, masked EGFR×CD3 T-cell engager designed to activate in the tumor microenvironment. The sponsor has discontinued JANX008 development because of insufficient magnitude and consistency of activity.

ClinicalTrials.gov ID: NCT05783622

A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Prodrug Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours

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.

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 good performance status and selected locally advanced unresectable or metastatic solid tumors—including certain sarcomas, salivary gland cancer, and triple-negative breast cancer—receive intravenous AVA6000 alone. This investigational prodrug is designed to release doxorubicin when cleaved by fibroblast activation protein (FAP) in tumor-associated stroma.

ClinicalTrials.gov ID: NCT04969835

A Phase 1 Study of SGN-PDL1V in Advanced 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.

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 metastatic or unresectable solid tumors and ECOG 0–1 receive PF-08046054, a PD-L1-targeted antibody–drug conjugate that delivers the microtubule inhibitor MMAE, alone or with the PD-1 inhibitor pembrolizumab. Combination cohorts are limited to PD-L1-positive NSCLC or head and neck squamous cell carcinoma.

ClinicalTrials.gov ID: NCT05208762

A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With ABBV-514 as a Single Agent and in Combination With Budigalimab

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.

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 ECOG 0–1 and refractory advanced solid tumors are eligible for dose escalation; expansion focuses on unresectable or metastatic NSCLC or HNSCC previously treated with platinum chemotherapy and PD-1/PD-L1 blockade, excluding NSCLC with known EGFR mutations or ALK rearrangements. Patients receive intravenous ABBV-514, an investigational anti-CCR8 antibody designed to deplete tumor-infiltrating regulatory T cells, alone or with budigalimab, an investigational anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT05005403