Clinical Trials for Breast Cancer

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

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: Eligible patients are adults with advanced, unresectable, or recurrent solid tumors or lymphomas that have progressed on standard therapy and have at least one injectable, measurable lesion; they will receive intratumoral ONM-501, a dual-activating STING agonist, either alone or in combination with intravenous cemiplimab, a PD-1 inhibitor. Key exclusions include active or untreated brain metastases, recent major surgery, and active autoimmune disease (for combination cohorts).

ClinicalTrials.gov ID: NCT06022029

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative 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.

TrialFetch AI summary: This trial enrolls adults with newly diagnosed, untreated metastatic triple negative breast cancer that is negative for PD-L1, evaluating nab-paclitaxel plus durvalumab (PD-L1 inhibitor) and tremelimumab (CTLA-4 inhibitor), with or without the addition of a personalized neoantigen peptide vaccine plus poly-ICLC as an immunologic adjuvant. Patients must have accessible tumor tissue, good performance status, and meet organ function requirements.

ClinicalTrials.gov ID: NCT03606967

PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced 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.

TrialFetch AI summary: This trial enrolls adults with advanced solid tumors, particularly breast cancer (including HR+/HER2-, HER2+, and HER2-low subtypes), or select non-breast cancers, all of which harbor a PI3KαH1047R mutation; participants receive OKI-219, a highly selective PI3KαH1047R inhibitor, as monotherapy or in combination with fulvestrant or trastuzumab. Eligible patients must have measurable disease, ECOG 0-1, and adequate organ function.

ClinicalTrials.gov ID: NCT06239467

A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination 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.

TrialFetch AI summary: This trial enrolls adults with ER-positive, HER2-negative advanced or metastatic breast cancer previously treated with endocrine therapy (and CDK4/6 inhibitors depending on arm) to evaluate the safety and efficacy of elacestrant, an oral selective estrogen receptor degrader, in combination with various targeted agents including alpelisib (PI3K inhibitor), everolimus (mTOR inhibitor), palbociclib/abemaciclib/ribociclib (CDK4/6 inhibitors), and capivasertib (AKT inhibitor). Key exclusions are active CNS disease, symptomatic visceral crisis, and prior use of elacestrant or the relevant combination partner in the metastatic setting.

ClinicalTrials.gov ID: NCT05563220

An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy 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: This trial enrolls adults with advanced solid tumors harboring deleterious or suspected deleterious BRCA1/2 or other homologous recombination repair mutations—such as HER2-negative BRCA-mutant breast cancer, high-grade serous ovarian or fallopian tube cancer, metastatic castration-resistant prostate cancer, and pancreatic cancer—who have progressed on, are intolerant to, or are ineligible for standard therapies (including PARP inhibitors). Patients receive the investigational oral USP1 inhibitor XL309, which disrupts DNA repair, as monotherapy or in combination with olaparib.

ClinicalTrials.gov ID: NCT05932862

Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax

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 hepatocellular, renal cell, breast, ovarian/fallopian, or endometrial/primary peritoneal cancers involving the abdomen or thorax who have progressed on or are intolerant to standard therapies, and evaluates safety of Tumor Treating Fields (TTF) in combination with either cabozantinib (a multi-kinase inhibitor targeting MET, VEGFR, and AXL) or nab-paclitaxel plus atezolizumab (a PD-L1 inhibitor).

ClinicalTrials.gov ID: NCT05092373

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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