Clinical Trials for Breast Cancer

Phase I Trial Of Alpelisib Plus Sacituzumab Govitecan In Patients With Metastatic Or Locally Recurrent HER2-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.

HealthScout AI summary: This trial enrolls adults with metastatic or locally advanced, unresectable HER2-negative breast cancer (either hormone receptor-positive or triple negative) who have received prior chemotherapy and hormonal therapy, and tests the combination of alpelisib (a PI3K-alpha inhibitor) and sacituzumab govitecan (a Trop-2-directed antibody-drug conjugate) to determine safety and dose for future studies. Patients with stable brain metastases are eligible.

ClinicalTrials.gov ID: NCT05143229

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.

HealthScout 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.

HealthScout 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.

HealthScout 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

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.

HealthScout 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.

HealthScout 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.

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/b Study of ADRX-0706 in Subjects with Select 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 solid tumors refractory to standard therapies—including urothelial, head and neck squamous cell, breast (triple negative), cervical, ovarian, non-small cell lung, and pancreatic cancers—with expansion cohorts for urothelial, triple negative breast, and cervical cancers. Patients are treated with ADRX-0706, a first-in-human antibody-drug conjugate targeting Nectin-4 and delivering a tubulin inhibitor payload.

ClinicalTrials.gov ID: NCT06036121