Clinical Trials for Breast Cancer

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 either HER2-positive metastatic breast cancer that has progressed after prior therapy including T-DXd, or RAS/BRAF wild-type, pMMR/MSS metastatic colorectal cancer that has progressed after oxaliplatin-based first-line therapy, to receive the investigational CD47-blocking fusion protein evorpacept (which enhances macrophage-mediated phagocytosis) in combination with trastuzumab plus chemotherapy or with cetuximab and FOLFIRI, respectively. Candidates must have measurable disease, ECOG 0-1, and adequate organ function.

ClinicalTrials.gov ID: NCT07007559

A First-in-Human (FIH), Open-Label, Phase Ia/Ib Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-DP in Participants With Relapsed/Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 adult patients with advanced, relapsed, or treatment-refractory solid tumors—including specific expansion cohorts for breast, pancreatic, ovarian, or colorectal cancer—may receive SON-DP, a first-in-class investigational protein that reprograms malignant cells into normal tissue cells rather than killing them, via IV infusion.

ClinicalTrials.gov ID: NCT05989724

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 adult women with ER-positive, HER2-negative advanced breast cancer previously treated with CDK4/6 inhibitors or with metastatic high-grade serous ovarian cancer previously treated with platinum-based chemotherapy. The trial investigates AZD8421, an oral CDK2 inhibitor, as monotherapy or in combination with either camizestrant (oral SERD) or a CDK4/6 inhibitor.

ClinicalTrials.gov ID: NCT06188520

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 or metastatic solid tumors (ECOG 0-1, no active CNS metastases) to receive GI-102, a bispecific CD80–IL-2 variant fusion protein designed to selectively activate CD8+ T and NK cells, as monotherapy or combined with standard regimens, including pembrolizumab and trastuzumab deruxtecan (for HER2+ disease).

ClinicalTrials.gov ID: NCT05824975

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 or metastatic solid tumors that have progressed on at least three months of pembrolizumab, evaluating the investigational oral integrin αvβ8/αvβ1 inhibitor PLN-101095 as monotherapy or combined with pembrolizumab. Eligible patients must have no other effective treatment options and prior pembrolizumab resistance (primary or secondary).

ClinicalTrials.gov ID: NCT06270706

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, or With the mTOR Inhibitor Everolimus in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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 study enrolls adults with advanced or metastatic ER-positive, HER2-negative breast cancer (with limited prior systemic therapy) to receive OP-1250 (palazestrant), a complete estrogen receptor antagonist and degrader, in combination with either ribociclib (CDK4/6 inhibitor), alpelisib (PI3K inhibitor), or everolimus (mTOR inhibitor). Eligible patients must have measurable or evaluable disease and ECOG 0-1.

ClinicalTrials.gov ID: NCT05508906

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 patients with advanced, locally unresectable or metastatic breast cancer of any HER2 status (including HER2-positive, HER2-low, HER2-ultralow, HER2-negative/triple-negative), investigating the combination of BNT323 (a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor) and BNT327 (a bispecific antibody targeting PD-L1 and VEGF-A), with some arms evaluating each agent as monotherapy. Eligible patients are generally pretreated with chemotherapy and must have measurable disease.

ClinicalTrials.gov ID: NCT06827236

Comparing Oral Drug Dosing Strategies in Older Patients With Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: This trial enrolls patients aged 65 or older with HR+/HER2- metastatic breast cancer who are eligible for combination endocrine therapy plus either palbociclib or ribociclib (CDK4/6 inhibitors), and randomizes them to receive either standard starting doses or lower, titratable doses of the selected CDK4/6 inhibitor. The goal is to determine which dosing approach better maximizes medication tolerance and reduces early discontinuation in this older population.

ClinicalTrials.gov ID: NCT06377852

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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, HER2-expressing solid tumors (including gynecologic, urothelial, biliary tract, breast, lung, and gastrointestinal cancers) who have progressed after at least two prior lines of standard therapy. All participants receive BL-M07D1, an investigational HER2-directed antibody-drug conjugate that delivers a topoisomerase I inhibitor (Ed-04) selectively to tumor cells via IV infusion every 21 days.

ClinicalTrials.gov ID: NCT06293898

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043