Clinical Trials for Bladder Cancer

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

TrialFetch AI summary: Adult patients with unresectable locally advanced or metastatic solid tumors (including melanoma, renal cell carcinoma, or PD-L1-positive NSCLC) who have progressed after or are ineligible for standard therapies receive AU-007, a novel monoclonal antibody that redirects IL-2 activity toward effector T and NK cells by blocking IL-2Rα, as monotherapy or in combination with recombinant IL-2 and/or checkpoint inhibitors. Patients must have adequate organ function, resolved prior immunotherapy toxicity, and measurable or evaluable disease.

ClinicalTrials.gov ID: NCT05267626

A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

TrialFetch AI summary: This trial enrolls adults with metastatic or unresectable solid tumors (including NSCLC, HNSCC, HER2-negative breast, esophageal, cutaneous SCC, ovarian, bladder, cervical, pancreatic, and gastric cancers), evaluating the antibody-drug conjugate sigvotatug vedotin—targeting integrin beta-6—with or without pembrolizumab and/or platinum chemotherapy. Eligibility varies by cohort, including both treatment-naïve and previously treated/refractory patients, with fresh or recent tumor biopsy required in some arms.

ClinicalTrials.gov ID: NCT04389632

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients with Extra-Cranial Soft Tissue Metastases

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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors and at least two extracranial soft tissue metastases (one ≥4 cm) requiring palliative radiation, comparing lattice radiation therapy (LRT)—a spatially fractionated radiotherapy technique that may enhance immune effects—to standard SBRT, with each patient receiving both treatments at different sites.

ClinicalTrials.gov ID: NCT05837767

A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer

TrialFetch AI summary: Adults with advanced solid tumors—such as high grade serous ovarian, squamous NSCLC, triple negative breast, gastric, colorectal, esophageal, bladder, head and neck, and select gynecologic cancers—who have progressed on standard therapies receive oral VLS-1488, a selective inhibitor of the mitotic kinesin KIF18A, given in 28-day cycles. Patients with active CNS metastases, prior KIF18A inhibitor exposure, or MSI-H/dMMR tumors are excluded.

ClinicalTrials.gov ID: NCT05902988

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

TrialFetch AI summary: This trial enrolls adults with stage IV solid tumors—including NSCLC, colorectal, breast, or bladder cancer—who are candidates for NGS testing prior to first or second-line metastatic therapy, and evaluates centralized precision oncology navigation and expert NGS review to increase use of existing targeted therapies and biomarker-driven clinical trial referrals. No investigational drugs are provided; the study focuses on optimizing precision oncology care using standard of care treatments.

ClinicalTrials.gov ID: NCT06896162

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

TrialFetch 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

A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors

TrialFetch AI summary: This trial enrolls adults with advanced, nonresectable, or metastatic solid tumors—including HR+/HER2- breast cancer, platinum-resistant serous ovarian, endometrial, and other tumors with likely CDK2 dependency—who have progressed on standard therapies. Patients receive the investigational selective CDK2 inhibitor BG-68501 as monotherapy or in combination with fulvestrant, with HR+/HER2- breast cancer patients also eligible for a triple combination with fulvestrant and the selective CDK4 inhibitor BGB-43395.

ClinicalTrials.gov ID: NCT06257264

A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select Solid Tumors

Active drug

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

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.

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 HR+/HER2- breast cancer, squamous head and neck, urothelial, or endometrial cancers harboring PIK3CA mutations or amplifications, who have not previously received PI3K, AKT, or mTOR inhibitors. Patients receive TOS-358, a first-in-class, covalent, and selective PI3Kα inhibitor, administered orally as a single agent.

ClinicalTrials.gov ID: NCT05683418

A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive Solid Tumors

TrialFetch AI summary: Eligible adult patients have advanced, refractory HER2-positive solid tumors with at least one injectable lesion. The trial evaluates safety and preliminary efficacy of intratumoral CAdVEC, an oncolytic adenovirus expressing IL-12 and a PD-L1 blocker, alone or in combination with intravenous HER2-specific autologous CAR T cells at higher dose levels.

ClinicalTrials.gov ID: NCT03740256

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant Malignancies

Active drug

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

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.

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 (including HNSCC, NSCLC, colorectal, TNBC, RCC, and acral melanoma) that are refractory or resistant to standard therapies, testing the investigational HLA-G antagonist monoclonal antibody TTX-080 alone or combined with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. Control arms include standard regimens for comparison in metastatic colorectal cancer.

ClinicalTrials.gov ID: NCT04485013