Clinical Trials

FDA's new guidance clarifies overall survival data collection in clinical trials, emphasizing long-term follow-up, subgroup analysis, and trial design considerations.

Dr Harpreet Singh explores the FDA's new guidance on overall survival as a clinical trial endpoint, addressing its implications and challenges in oncology.

A groundbreaking trial for TYRA-300, an oral FGFR3 inhibitor, aims to transform treatment for patients with low-grade intermediate-risk bladder cancer.

Travel barriers and lack of local sites hinder clinical trial enrollment for underserved patients, and decentralizing trials is key to improving access, according to Mariam Eskander, MD, MPH.

A groundbreaking telehealth trial offers remote access to innovative pancreatic cancer treatment, enhancing patient participation and care coordination nationwide.

The pivotal AMPLIFY trial aims to support FDA approval of ⁶⁴Cu-SAR-bisPSMA as a best-in-class imaging tool in prostate cancer.

Cohort 1 of the GTB-3650 phase 1 trial completed with no safety issues observed in patients with CD33-expressing hematologic malignancies.

Deepak Bhamidipati, MD, discusses a review conducted to investigate how the design of early-phase clinical trials has evolved.

Deepak Bhamidipati, MD, discusses the impact of the FDA's Project Optimus on early-phase drug development protocols.

Manmeet Ahluwalia, MD, MBA, FASCO, highlights genomic testing as a crucial area of current research with immediate implications for patients with brain cancer.

A phase 1 trial of mRNA-4106 has dosed its first patient with an advanced or metastatic solid tumor.

Mack Roach III, MD, discusses concerns about how tariffs and restrictions on international collaboration could negatively affect cancer research and treatment.

Trials of IFx-Hu2.0 are initiating, looking to overcome checkpoint inhibitor resistance in Merkel cell carcinoma.

Levee Medical has begun its pivotal ARID II trial, studying the Voro Scaffold for improved continence after prostatectomy.

Following promising phase 1 data, TCMCB07 is being further evaluated in a phase 2 trial for the treatment of patients with stage IV colorectal cancer.

A phase 1/2 trial of CRISPR-engineered eTIL therapy KSQ-004EX for advanced solid tumors has dosed its first patient.

A phase 1 open-label trial is underway, evaluating the safety and efficacy of CT-95 in patients with mesothelin-expressing advanced solid tumors.

The fourth cohort of an ongoing phase 1/2 has dosed its first patient with TTX-MC138 in advanced solid tumors.

The first patient has been enrolled in the PROSTATE-IQ trial of ArteraAI, a multimodal artificial intelligence biomarker test.

The first patient was dosed in a phase 1/2 trial of evofosfamide with checkpoint inhibitors for hypoxia-reversal in resistant solid tumors.

A phase 1/2 trial is evaluating HLD-0915, a novel oral therapy, for metastatic castration-resistant prostate cancer in up to 80 patients.

Alfred L. Garfall, MD, emphasizes the critical importance of the National Institutes of Health funding for biomedical research.

A global, randomized, phase 1b/2 trial is evaluating IO-108 in patients with metastatic and/or unresectable hepatocellular carcinoma.

IB-T101, a CD70-targeted chimeric antigen receptor therapy, is being studied for relapsed clear cell renal cell carcinoma treatment in a dose-escalation trial.

The first patient with myelodysplastic syndrome has received iadademstat plus azacitidine in a phase 1 trial at the Medical College of Wisconsin.

Dosing has started in a clinical evaluating peluntamig, which targets DLL3 and CD47, combined with chemotherapy in patients with DLL3-expressing cancers.

The FORTIFI-HN01 trial has begun enrolling patients with advanced head and neck cancer to evaluate ficerafusp alfa plus pembrolizumab as a first-line therapy.

Mariam F. Eskander, MD, MPH, and Coral O. Omene, MD, PhD, discuss some specific practices and policies that have been most effective at their institution and how these may be adopted by other practices.

Mariam F. Eskander, MD, MPH, and Coral O. Omene, MD, PhD, discuss how medical mistrust has impacted participation in oncology clinical trials.

Mariam F. Eskander, MD, MPH, and Coral O. Omene, MD, PhD, discuss potential strategies that teams can implement to ensure clinical trials are more representative of the general population.