Clinical Trials for Breast Cancer

A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory 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.

TrialFetch AI summary: Adults with refractory locally advanced or metastatic solid tumors limited to NSCLC, TNBC, HNSCC, esophageal (SCC/adenocarcinoma), gastric/GEJ adenocarcinoma, and gynecologic (cervical/endometrial/ovarian) cancers (ECOG 0–1) receive NRM-823, a bispecific T‑cell engager targeting CD3 and a novel tumor antigen, as monotherapy with dose escalation/expansion, with a cohort combining NRM-823 plus an immune checkpoint inhibitor. Primary focus is safety and RP2D determination, with preliminary antitumor activity assessment.

ClinicalTrials.gov ID: NCT07182149

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 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.

TrialFetch AI summary: Adults with measurable advanced/metastatic breast cancer (progressed after ≥1 line endocrine therapy and a CDK4/6 inhibitor) or advanced/metastatic colorectal cancer (previously treated per standard options, plus one cohort without prior chemo for metastatic disease), ECOG 0–1. Participants receive oral investigational agent PF-08032562 (target/mechanism not publicly described) as monotherapy or combined with fulvestrant (breast) or cetuximab or FOLFOX + bevacizumab (colorectal) in 28-day cycles with dose escalation/expansion.

ClinicalTrials.gov ID: NCT07318805

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents 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.

TrialFetch AI summary: Enrolls adults with measurable advanced/metastatic breast cancer (primary focus; postmenopausal or on ovarian suppression, ECOG 0–1) and select other refractory advanced solid tumors; Part 1A includes heavily pretreated patients lacking standard options, while breast cancer expansion cohorts include patients with 1–3 prior metastatic lines or (in certain regions) CDK4/6-inhibitor–naïve and untreated for advanced disease. Tests oral BG-75202, a small-molecule KAT6A/KAT6B lysine acetyltransferase inhibitor, as monotherapy and in combination with endocrine therapy (estrogen receptor antagonist) and with CDK4 inhibition plus an aromatase inhibitor.

ClinicalTrials.gov ID: NCT07222267

An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other 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.

TrialFetch AI summary: Enrolls adults with advanced malignancies, primarily HR+/HER2− advanced breast cancer that has progressed after endocrine therapy plus a CDK4/6 inhibitor (phase II limited to ≤2 prior endocrine lines for advanced disease and no prior chemotherapy/ADC in the advanced setting), with additional phase I cohorts for CCNE1-amplified solid tumors and metastatic castration-resistant prostate cancer. Patients receive the first-in-human investigational agent GVV858 (target/mechanism not publicly specified) as monotherapy or combined with endocrine therapy—fulvestrant (and letrozole in phase I), with phase II evaluating two GVV858 dose regimens plus fulvestrant.

ClinicalTrials.gov ID: NCT07288359

A Phase 1, Open-label, Multicenter Clinical Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Anti-Cancer Activity of PQ203 in Patients With Advanced Solid Tumor 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.

TrialFetch AI summary: Adults with metastatic or locally advanced solid tumors (including interest in TNBC) that have progressed after or are ineligible for standard therapy, with ECOG 0–1, measurable disease, adequate organ/cardiac function, and no significant cardiac disease/QTc prolongation, active >grade 1 neuropathy, or prior MMAE- or SORT1-targeted therapy. Participants receive PQ203, a once-weekly IV SORT1-targeting peptide–drug conjugate delivering the microtubule inhibitor MMAE to SORT1-expressing tumor cells, in dose-escalation/optimization to establish RP2D and assess preliminary antitumor activity.

ClinicalTrials.gov ID: NCT07190469

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ 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.

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: The trial involves patients who are postmenopausal women with relapsed locally advanced or metastatic AR+/HER2-/ER+ breast cancer, focusing on the safety and efficacy of EP0062 (vosilasarm), a selective androgen receptor modulator. Participants must have previously treated, inactive cancer and meet specific cardiac and medication criteria.

ClinicalTrials.gov ID: NCT05573126

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma

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.

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: The trial investigates the use of AG01, an anti-progranulin/GP88 monoclonal antibody, in patients with relapsed or refractory advanced solid tumors, including triple negative breast cancer, hormone-resistant breast cancer, non-small cell lung cancer, and mesothelioma, who have no remaining effective treatment options. AG01 is administered biweekly to evaluate its safety, tolerability, and preliminary anti-tumor activity.

ClinicalTrials.gov ID: NCT05627960

A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid 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.

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 involves adult patients with advanced or metastatic solid tumors such as melanoma and non-small cell lung cancer who have relapsed after standard treatments, testing the investigational agent ST-067 alone or with pembrolizumab and obinutuzumab to enhance immune response against tumor cells.

ClinicalTrials.gov ID: NCT04787042

A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma

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.

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 previously treated advanced MYC-driven or selected solid tumors—including NSCLC, SCLC, high-grade neuroendocrine cancers, L- or N-MYC amplified solid tumors, or diffuse large B-cell lymphoma—testing oral MRT-2359, a GSPT1-targeting molecular glue degrader, as monotherapy or in combination with fulvestrant (HR+/HER2- breast cancer) or enzalutamide (prostate cancer).

ClinicalTrials.gov ID: NCT05546268

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types

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.

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 or diffuse large B-cell lymphoma who have exhausted standard therapies, evaluating the investigational oral CBL-B inhibitor NX-1607 (which enhances antitumor immunity by blocking a negative regulator of immune cell activation) as monotherapy or in combination with paclitaxel. Eligible tumor types include ovarian, gastric, head and neck, melanoma, NSCLC, prostate, mesothelioma, triple-negative breast, urothelial, cervical, microsatellite-stable colorectal cancer, and DLBCL/Richter transformation.

ClinicalTrials.gov ID: NCT05107674