Clinical Trials for Bladder Cancer

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 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.

HealthScout AI summary: This trial enrolls adults with unresectable, locally advanced or metastatic solid tumors—including a wide range such as head and neck, lung, bladder, prostate, breast, colorectal, and others—who have progressed on or are intolerant to standard therapies. Patients receive MGC026, a B7-H3-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor (exatecan), with cohorts in both dose escalation and expansion phases.

ClinicalTrials.gov ID: NCT06242470

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

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.

HealthScout AI summary: This study enrolls adults with unresectable, locally advanced, or metastatic antigen-rich solid tumors—including TMB-H, MSI-H/dMMR, virally associated, metastatic colorectal, triple negative breast, platinum-resistant ovarian, metastatic castration-resistant prostate, and NSCLC—who lack standard treatment options. Patients receive STAR0602 (invikafusp alfa), a bifunctional bispecific antibody that selectively activates and expands Vβ6/Vβ10 T cell subsets to enhance antitumor immunity.

ClinicalTrials.gov ID: NCT05592626

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

HealthScout 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

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally 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.

HealthScout AI summary: This trial is enrolling adults with previously treated, locally advanced or metastatic solid tumors (including urothelial carcinoma and other Nectin-4–positive types) who have measurable disease and good performance status. Patients receive [225Ac]Ac-AKY-1189, an investigational Nectin-4–targeting radiopharmaceutical that delivers actinium-225 directly to tumor cells, in up to six cycles following Nectin-4 PET imaging confirmation.

ClinicalTrials.gov ID: NCT07020117

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M17D1 in Subjects With HER2-Expressing or HER2-Mutant 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.

HealthScout AI summary: This trial enrolls adults with unresectable, locally advanced, or metastatic HER2-positive or HER2-mutant solid tumors (including but not limited to breast, gastric/GEJ, NSCLC, endometrial, ovarian, and urothelial cancers) who have progressed on or are not candidates for standard therapy. Patients receive BL-M17D1, an investigational HER2-targeted antibody-drug conjugate, given intravenously on Days 1 and 8 of a 21-day cycle.

ClinicalTrials.gov ID: NCT06714617

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

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.

HealthScout 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

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

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.

HealthScout AI summary: Adult patients with advanced solid tumors that are HLA-A*02:01 positive and harbor the p53 R175H mutation (confirmed by testing) receive CLSP-1025, a bispecific T-cell engager targeting the p53 R175H mutant peptide on tumor cells, as monotherapy. Prior p53 R175H-directed therapy, germline p53 mutations, and several comorbidities are exclusion criteria.

ClinicalTrials.gov ID: NCT06778863

A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, 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.

HealthScout 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

Phase 1, Open-Label, Multicenter, First-In-Human Trial of Ds-2243a 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.

HealthScout AI summary: Adults with HLA-A2–positive advanced solid tumors (synovial sarcoma, myxoid/round cell liposarcoma, NSCLC adenocarcinoma/squamous, or urothelial carcinoma) after appropriate prior therapy receive subcutaneous DS-2243a, a bispecific T‑cell engager targeting CD3 and the HLA‑A*02/NY‑ESO‑1 peptide complex, with step-up dosing. Includes dose escalation and tumor-specific expansion; excludes prior NY‑ESO‑1–targeted therapy and requires measurable disease and ECOG 0–1.

ClinicalTrials.gov ID: NCT06644755

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

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.

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.

HealthScout AI summary: Enrolling adults with metastatic rare genitourinary cancers across multiple histologic cohorts (e.g., small cell/neuroendocrine bladder, variant urothelial, penile, sarcomatoid/unclassified RCC, collecting duct, renal medullary, urethral; including a bone-only GU cohort), with up to two prior lines allowed (cohort-specific exceptions. Patients receive cabozantinib (MET/VEGFR2/AXL multi-kinase inhibitor) plus nivolumab (PD-1) and ipilimumab (CTLA-4) for up to 2 years.

ClinicalTrials.gov ID: NCT03866382