Clinical Trials for Breast Cancer

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: Adults with advanced or metastatic solid tumors expressing HER2 (including HER2-low), who are refractory or intolerant to standard therapies, receive the investigational HER2-targeted antibody-drug conjugate DB-1303/BNT323 (anti-HER2 IgG1 linked to a DNA topoisomerase I inhibitor) IV every 3 weeks; select cohorts also examine combinations with pertuzumab or CYP inhibitors for drug-drug interaction assessment.

ClinicalTrials.gov ID: NCT05150691

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 who have progressed on, or are not candidates for, standard therapies (including anti-PD-1 where appropriate) may be eligible for this trial of BMS-986340, an investigational anti-CCR8 monoclonal antibody targeting tumor-infiltrating regulatory T cells, given as monotherapy or in combination with nivolumab or docetaxel. Patients must have measurable disease, ECOG 0-1, and be able to undergo mandatory tumor biopsies.

ClinicalTrials.gov ID: NCT04895709

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

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: Eligible patients have locally advanced or metastatic solid tumors with HER2 expression—including NSCLC, breast (both HER2+ and HER2-), urothelial, gastric, esophageal, or other Erbb2-amplified cancers—who have progressed on or are intolerant to standard treatments. Patients receive DF1001, a tri-specific NK cell engager targeting HER2 and activating NK and T cells, as monotherapy or in combination with nivolumab, nab-paclitaxel, or sacituzumab govitecan-hziy.

ClinicalTrials.gov ID: NCT04143711

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients with Extra-Cranial Soft Tissue Metastases

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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors and at least two extracranial soft tissue metastases (one ≥4 cm) requiring palliative radiation, comparing lattice radiation therapy (LRT)—a spatially fractionated radiotherapy technique that may enhance immune effects—to standard SBRT, with each patient receiving both treatments at different sites.

ClinicalTrials.gov ID: NCT05837767

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: Eligible patients are adults with locally advanced or metastatic FAP-positive solid tumors, including high-grade soft-tissue sarcoma, salivary gland carcinoma, and triple-negative breast cancer, who have progressed on or are ineligible for standard therapies. Patients receive intravenous AVA6000, a FAP-activated doxorubicin prodrug designed to deliver doxorubicin selectively to tumor tissue in order to minimize systemic toxicity.

ClinicalTrials.gov ID: NCT04969835

Single Arm Study to Assess the Immune Effects of Fermented Wheat Germ (FWG) Nutritional Supplementation in Patients With Advanced Malignancies Being Treated With Standard of Care Checkpoint Inhibitor-Based Therapy

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.

TrialFetch AI summary: Adults with advanced non-small cell lung, renal cell, melanoma, colorectal, or triple-negative breast cancers eligible for standard checkpoint inhibitor immunotherapy will receive oral fermented wheat germ supplementation (a nutritional product with proposed but unproven immunomodulatory effects) alongside their standard immunotherapy regimen. No chemotherapy, radiotherapy, or recent immunomodulatory agents are allowed prior to enrollment.

ClinicalTrials.gov ID: NCT05967533

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: This trial enrolls adults with metastatic or unresectable, PD-L1–expressing solid tumors (including NSCLC, HNSCC, esophageal SCC, TNBC, ovarian cancer, melanoma, and gastric cancer) who have failed or are ineligible for standard therapies. Patients receive either SGN-PDL1V, an antibody-drug conjugate targeting PD-L1 and delivering MMAE, or a combination of SGN-PDL1V plus pembrolizumab.

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: This trial enrolls adults with advanced or metastatic solid tumors, including NSCLC or HNSCC, who have progressed after platinum-based chemotherapy and PD-1/PD-L1 inhibitors, and are treated with ABBV-514 (an anti-CCR8 monoclonal antibody designed to deplete tumor-infiltrating Tregs) as monotherapy or in combination with budigalimab (a PD-1 inhibitor). NSCLC patients with EGFR or ALK alterations are excluded from the dose-expansion cohorts.

ClinicalTrials.gov ID: NCT05005403

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

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.

TrialFetch AI summary: This trial enrolls adults with previously treated, locally advanced or metastatic, HER2 IHC 3+ solid tumors (excluding biliary tract cancers) who have progressed after at least one prior systemic therapy and lack standard treatment options; patients receive zanidatamab, a bispecific antibody targeting two HER2 epitopes. Eligible patients must have measurable disease, ECOG 0–1, and no active CNS metastases.

ClinicalTrials.gov ID: NCT06695845

A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With 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.

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 trial enrolls adults with advanced or metastatic ER+/HER2- breast cancer who have progressed after endocrine therapy and a CDK4/6 inhibitor, as well as selected patients with castration-resistant prostate cancer or non–small-cell lung cancer refractory to standard treatments. Participants receive PF-07248144, a selective KAT6A/B histone acetyltransferase inhibitor, as monotherapy or in combination with endocrine therapy or other investigational agents.

ClinicalTrials.gov ID: NCT04606446