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

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

An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or 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 advanced solid tumors or lymphoma that are refractory to standard therapies, whose tumors overexpress TrkA or harbor an NTRK1 gene fusion, to receive oral VMD-928, a highly selective irreversible TrkA inhibitor that acts via allosteric dimerization and inactivation of the target. Key exclusions include significant comorbidities and impaired drug absorption.

ClinicalTrials.gov ID: NCT03556228

A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced 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.

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 selected advanced solid tumors—including NSCLC, renal cell carcinoma, melanoma, platinum-resistant ovarian cancer, nasopharyngeal carcinoma, and triple negative breast cancer—who have progressed after specific prior therapies, to evaluate the safety and dosing of KFA115 (a novel immunomodulatory small molecule, presumed to enhance anti-tumor immunity) as monotherapy and in combination with pembrolizumab. Exclusion criteria include significant cardiac, autoimmune, and interstitial lung diseases, as well as history of severe hypersensitivity to study drugs.

ClinicalTrials.gov ID: NCT05544929

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.

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 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, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected 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.

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 adults with advanced or metastatic solid tumors (including selected breast, gynecologic, and gastrointestinal cancers) who have progressed on or are ineligible for standard therapies, investigating INCB123667 (mechanism unknown) as monotherapy or in combination with agents such as palbociclib, ribociclib, fulvestrant, bevacizumab, olaparib, or paclitaxel. Patients must have good performance status (ECOG 0-1), and the trial includes tumor-specific expansion cohorts.

ClinicalTrials.gov ID: NCT05238922

First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With 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.

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 solid tumors (such as pancreatic, colorectal, and breast cancers) who have progressed after standard therapies, as well as adolescents (12–17 years) with solid tumors lacking standard options (excluding rhabdomyosarcoma), to receive oral metarrestin, a first-in-class small molecule that targets the perinucleolar compartment to disrupt ribosome biogenesis and inhibit metastasis.

ClinicalTrials.gov ID: NCT04222413