Clinical Trials for Breast Cancer

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

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 unresectable solid tumors harboring AKT/PI3K/PTEN pathway alterations (excluding concurrent EGFR/KRAS/NRAS/HRAS/BRAF drivers) receive the investigational AKT-pathway inhibitor TER-2013 as monotherapy (expansion in ovarian/cervical/SCCHN/lung/esophageal and endometrial cancers) or with fulvestrant for HR+/HER2- breast cancer previously treated with an aromatase inhibitor. Prior AKT/PI3K/PTEN inhibitors (and prior SERD/mTOR in combo expansion) are excluded; requires ECOG 0–1 and adequate organ function.

ClinicalTrials.gov ID: NCT07109726

A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, 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: Adults with advanced solid tumors harboring AKT1 E17K mutations, including a cohort with HR+/HER2- metastatic breast cancer, receive the oral selective AKT1 E17K allosteric inhibitor ATV-1601 as monotherapy or in combination with fulvestrant. The trial excludes tumors with activating RAS/BRAF mutations and aims to identify dosing and preliminary activity while minimizing AKT2-related metabolic toxicities.

ClinicalTrials.gov ID: NCT07038369

An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression

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 incurable, locally advanced/metastatic Nectin-4–positive solid tumors—emphasizing relapsed/refractory urothelial cancer—receive RNDO-564 weekly as monotherapy or combined with pembrolizumab every 3 weeks. RNDO-564 is a fully human CD28 × Nectin-4 costimulatory bispecific antibody intended to deliver localized CD28 T‑cell costimulation at Nectin-4–expressing tumors; early cohorts include multiple Nectin-4–associated cancers, with randomized dose-optimization in urothelial cancer.

ClinicalTrials.gov ID: NCT07218003

A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult 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: Adults with advanced solid tumors refractory to standard therapy (ECOG 0–1, measurable disease) receive a single intravenous infusion of IDOV-Immune (VM-002), a genetically engineered oncolytic vaccinia virus designed for tumor-selective replication and lysis with immune-stimulating transgenes to enhance antitumor immunity. Key exclusions include prior oncolytic virus therapy, recent vaccinia/smallpox vaccination, active autoimmune disease requiring systemic therapy, significant cardiopulmonary disease, uncontrolled infection, and unstable/untreated CNS metastases.

ClinicalTrials.gov ID: NCT06910657

A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

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 advanced/metastatic FAP-expressing solid tumors (including pancreatic, multiple breast cancer subtypes, platinum-resistant/refractory ovarian, and other FAP-positive GI tumors) and ECOG 0–1 receive intravenous LY4337713, a lutetium-177–labeled small-molecule radioligand targeting fibroblast activation protein on cancer-associated fibroblasts to deliver beta radiation to the tumor microenvironment, on Q4–6 week cycles. Expansion cohorts are tumor-specific after dose escalation/optimization.

ClinicalTrials.gov ID: NCT07213791

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, 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: Adults with advanced, refractory solid tumors (ECOG 0–1) receive an allogeneic, off‑the‑shelf iPSC‑derived CAR T product (FT836) targeting stress‑inducible MICA/MICB (engineered to reduce antigen shedding) as monotherapy or combined with trastuzumab (HER2), cetuximab (EGFR), and/or paclitaxel. Multi‑arm cohorts assess safety and preliminary activity to establish RP2D for the combination regimens.

ClinicalTrials.gov ID: NCT07216105

Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Patients 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: Adults with advanced ER/PR-positive, HER2-negative breast cancer, including endocrine-refractory disease and treated/stable brain metastases, undergo 68Ga-R11228 PET to identify GPCR-expressing tumors followed by dose-ranging 177Lu-R11228 radioligand therapy in PET-positive patients. R11228 is a GPCR-targeted theranostic pair (68Ga for imaging, 177Lu for beta-emitting therapy); prior systemic radionuclide therapy is excluded, and patients may receive up to six treatment cycles.

ClinicalTrials.gov ID: NCT07121244

A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, 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.

TrialFetch AI summary: Adults with advanced/metastatic NSCLC, SCLC, endometrial cancer, or triple‑negative breast cancer after standard options receive LY4175408, an investigational PTK7‑targeted antibody–drug conjugate delivering an exatecan (topoisomerase I inhibitor) payload, given IV every 21 days. Requires ECOG 0–1 and measurable disease (for later cohorts); excludes prior PTK7 topoisomerase I ADCs, uncontrolled CNS metastases, significant cardiac disease, ILD/pneumonitis, active infection, and prolonged QTc.

ClinicalTrials.gov ID: NCT07046923

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 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: Adults with advanced solid tumors including HNSCC, pancreatic adenocarcinoma, NSCLC, HR+/HER2− breast cancer post‑CDK4/6 inhibitor, or platinum‑resistant high‑grade serous ovarian/related cancers receive the oral CDK7 inhibitor GTAEXS617 (transcription/cell‑cycle regulator) as monotherapy or combined with standard-of-care regimens. Eligible patients have ECOG 0–1 and adequate organ function; study explores safety, PK, and preliminary activity with tumor biopsies required.

ClinicalTrials.gov ID: NCT05985655

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine 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: Adults with advanced solid tumors (dose escalation enriched for CDK4/CCND1-amplified tumors) and a phase 2 focus on HR+/HER2- metastatic breast cancer receive AVZO-023, an oral selective CDK4 inhibitor, as monotherapy or combined with AVZO-021 (selective CDK2 inhibitor) and/or endocrine therapy (fulvestrant or letrozole). Prior CDK2/4/6 inhibitor exposure is excluded; endpoints assess safety, PK/PD, and antitumor activity with combination cohorts at RP2D in HR+/HER2- disease.

ClinicalTrials.gov ID: NCT06998407