Clinical Trials for Breast Cancer

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 recurrent or metastatic hormone receptor–positive, HER2-negative breast cancer receive a single 68Ga-R11228 PET imaging dose; those with PET-positive lesions may receive up to six doses of 177Lu-R11228 radioligand therapy. The treatment cohort requires endocrine-refractory disease and prior chemotherapy or an antibody–drug conjugate, unless declined; R11228’s molecular target is not specified.

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 or metastatic NSCLC, SCLC, endometrial cancer, or triple-negative breast cancer who have received or declined standard therapy, or have no standard options, receive IV LY4175408. This investigational antibody–drug conjugate targets PTK7 and delivers exatecan, a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT07046923

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 NSCLC, triple-negative breast cancer, head and neck squamous cell carcinoma, esophageal or gastric/GEJ cancer, or cervical, endometrial, or ovarian cancer (ECOG 0–1) receive NRM-823 alone or with an immune checkpoint inhibitor. NRM-823 is an investigational T-cell engager intended to bring T cells into contact with tumor cells; its tumor-binding target has not been publicly confirmed.

ClinicalTrials.gov ID: NCT07182149

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR 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.

TrialFetch AI summary: Adults with measurable advanced or metastatic breast or colorectal cancer and ECOG 0–1 receive oral PF-08032562, an investigational KAT6A/KAT6B/KAT7 inhibitor, alone or with fulvestrant (breast cancer), cetuximab (colorectal cancer), or FOLFOX plus bevacizumab (colorectal cancer). Prior-treatment requirements vary by cohort.

ClinicalTrials.gov ID: NCT07318805

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents 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 measurable advanced solid tumors who have exhausted or cannot receive standard therapy may receive BG-75202, an oral KAT6A/KAT6B inhibitor, alone. Combination cohorts enroll patients with advanced breast cancer to receive BG-75202 with an estrogen receptor antagonist or with a CDK4 inhibitor plus an aromatase inhibitor; the CDK4 inhibitor cohorts require no prior systemic therapy for advanced disease or prior CDK4/6 inhibitor treatment.

ClinicalTrials.gov ID: NCT07222267

An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other 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 HR-positive/HER2-negative breast cancer progressing after CDK4/6 inhibitor–based endocrine therapy receive investigational oral CDK2/4 inhibitor GVV858 alone or with fulvestrant or letrozole; later cohorts focus on GVV858 plus fulvestrant. Early cohorts also include patients with CCNE1-amplified advanced solid tumors or metastatic castration-resistant prostate cancer.

ClinicalTrials.gov ID: NCT07288359

A Phase 1, Open-label, Multicenter Clinical Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Anti-Cancer Activity of PQ203 in Patients With Advanced Solid Tumor 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.

TrialFetch AI summary: Adults with measurable metastatic or locally advanced solid tumors after progression on standard therapy, or for whom standard therapy is unsuitable, receive weekly intravenous PQ203. This investigational peptide–drug conjugate targets SORT1 to deliver the cytotoxic payload MMAE into tumor cells.

ClinicalTrials.gov ID: NCT07190469

A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression

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 or unresectable solid tumors harboring ERBB2 alterations, NRG1 fusions, or HER2 overexpression receive oral CGT4255, an investigational HER2 inhibitor designed to target mutant and wild-type HER2 while sparing EGFR. Expansion cohorts focus on ERBB2-mutated NSCLC and ERBB2-mutated or HER2-overexpressing breast cancer, including patients with brain metastases.

ClinicalTrials.gov ID: NCT07361562

A Phase 1b/2 Study of ASP2998 as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or 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.

TrialFetch AI summary: Adults with locally advanced unresectable or metastatic urothelial carcinoma, NSCLC, gastric or gastroesophageal junction cancer, or HER2-negative breast cancer may be eligible, depending on cohort-specific prior therapy requirements. ASP2998, a TROP2-targeted antibody–drug conjugate carrying topoisomerase I inhibitor and STING agonist payloads, is given alone or with pembrolizumab, carboplatin, or enfortumab vedotin.

ClinicalTrials.gov ID: NCT07287995

An Open-Label, Multicenter, First-in-Human, Phase 1 Study of BBI-940 in Advanced or Metastatic Breast Cancer: Kinesin Oral Molecular Degrader for Oncology (KOMODO-1)

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 previously treated advanced or metastatic ER-positive/HER2-negative breast cancer or androgen receptor–positive luminal-subtype triple-negative breast cancer receive oral BBI-940 alone or, in an ESR1-wild-type cohort, with fulvestrant. BBI-940 is an investigational degrader of a kinesin protein involved in extrachromosomal DNA segregation; its development has been discontinued.

ClinicalTrials.gov ID: NCT07408089