Clinical Trials for Breast Cancer

A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

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.

HealthScout AI summary: This trial enrolls adults with metastatic, ER+/HER2-, GRPR-positive breast cancer who have progressed on prior endocrine therapy plus a CDK4/6 inhibitor, and evaluates the combination of capecitabine with [177Lu]Lu-NeoB, a novel radioligand that selectively targets GRPR-positive tumor cells with localized radiation. Prior capecitabine or radiopharmaceutical therapy is not permitted, and GRPR-positivity is confirmed by [68Ga]Ga-NeoB PET imaging.

ClinicalTrials.gov ID: NCT06247995

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

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.

HealthScout AI summary: Adult patients with advanced solid tumors that are HLA-A*02:01 positive and harbor the p53 R175H mutation (confirmed by testing) receive CLSP-1025, a bispecific T-cell engager targeting the p53 R175H mutant peptide on tumor cells, as monotherapy. Prior p53 R175H-directed therapy, germline p53 mutations, and several comorbidities are exclusion criteria.

ClinicalTrials.gov ID: NCT06778863

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab

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.

HealthScout AI summary: Eligible patients are adults with metastatic, refractory gastrointestinal, hepatobiliary, genitourinary, breast, ovarian, endometrial, or selected endocrine/neuroendocrine tumors who have failed standard therapies and have a resectable lesion for TIL generation. Treatment includes lymphodepleting chemotherapy, autologous tumor-infiltrating lymphocyte (TIL) infusion, high-dose aldesleukin, and pembrolizumab, a PD-1 immune checkpoint inhibitor, with timing of pembrolizumab varying by study arm.

ClinicalTrials.gov ID: NCT01174121

A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants 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.

HealthScout AI summary: This trial enrolls adults with advanced, nonresectable, or metastatic solid tumors—including HR+/HER2- breast cancer, platinum-resistant serous ovarian, endometrial, and other tumors with likely CDK2 dependency—who have progressed on standard therapies. Patients receive the investigational selective CDK2 inhibitor BG-68501 as monotherapy or in combination with fulvestrant, with HR+/HER2- breast cancer patients also eligible for a triple combination with fulvestrant and the selective CDK4 inhibitor BGB-43395.

ClinicalTrials.gov ID: NCT06257264

A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in 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.

HealthScout AI summary: Eligible patients are adults with advanced or metastatic triple-negative breast cancer, high-grade serous ovarian, primary peritoneal, fallopian-tube, or serous endometrial cancer, all with TP53 mutation/loss and progression after at least one prior line of therapy. Participants receive AO-252, an investigational oral small-molecule inhibitor of TACC3 protein-protein interactions.

ClinicalTrials.gov ID: NCT06136884

Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients with Metastatic Breast Cancer

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.

HealthScout AI summary: This trial enrolls adults with metastatic or recurrent breast adenocarcinoma of any subtype (ER/PR+, HER2+, or triple negative) who have progressed on standard therapies, to receive intratumoral injections of MV-s-NAP, an oncolytic measles virus engineered to express neutrophil-activating protein, aimed at inducing tumor cell lysis and immune activation. Treatment is administered directly into tumor lesions, with eligibility requiring adequate organ function and performance status.

ClinicalTrials.gov ID: NCT04521764

A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive Advanced Breast Cancer Experiencing Early Relapse From (Neo)Adjuvant Endocrine Therapy or Who Have Progressed on Endocrine Therapy in Combination With a CDK4/6 Inhibitor for Advanced Disease

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.

HealthScout AI summary: This trial enrolls adults with ER-positive, HER2-negative, GRPR-positive advanced breast cancer who have relapsed early after (neo)adjuvant endocrine therapy or progressed on prior endocrine therapy plus a CDK4/6 inhibitor, with up to one prior line of advanced therapy and no prior fulvestrant. Patients receive [177Lu]Lu-NeoB, a GRPR-targeted radioligand delivering beta radiation, in combination with ribociclib and fulvestrant.

ClinicalTrials.gov ID: NCT05870579

Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma

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.

HealthScout AI summary: This trial enrolls adults with advanced, superficial, and injectable head and neck cancer, breast cancer, soft tissue sarcoma, or melanoma that has progressed on or is ineligible for standard therapy. Patients receive intra-tumoral X-PACT, a novel approach using methoxsalen and a phosphor device activated by local X-ray to induce tumor cell death.

ClinicalTrials.gov ID: NCT04389281

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult 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.

HealthScout AI summary: This study enrolls adults with advanced or metastatic solid tumors (including ER+ breast cancer, triple negative breast cancer, ARID1A-mutated tumors, and small cell lung cancer) who have progressed on or cannot tolerate standard therapies, testing oral JAB-2485, a highly selective Aurora kinase A (AURKA) inhibitor. All patients must have ECOG 0-1 and measurable disease.

ClinicalTrials.gov ID: NCT05490472

Phase 1b/2 Study to Evaluate Antibody-Drug Conjugate Sacituzumab Govitecan in Combination With PARP Inhibitor Talazoparib in Patients With Metastatic Breast Cancer

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.

HealthScout AI summary: This trial enrolls adults with metastatic triple-negative breast cancer (ER-, PR-, HER2-) and tests the combination of sacituzumab govitecan (an anti–Trop-2 antibody-drug conjugate delivering SN-38) with talazoparib (a PARP inhibitor), assessing safety and preliminary efficacy in this population.

ClinicalTrials.gov ID: NCT04039230