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West Cancer Center
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BLADDER: METASTATIC: PHASE 1: ASPEN-07

A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Bladder cancer, urothelial carcinoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Evorpacept

Drug Class

Fusion protein blocking CD47-SIRPalpha

PI

Dan Vaena, MD

Sponsor

ALX Oncology

Path

Urothelial carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed unresectable locally advanced or metastatic urothelial carcinoma. Subjects with urothelial carcinoma with squamous differentiation or mixed cell types are eligible provided that urothelial is the dominant histology.  Any element of neuroendocrine or small cell histology are excluded
  • Must have received prior treatment with a immune checkpoint inhibitor in the locally advanced or metastatic setting
  • Must have received prior treatment with platinum containing chemotherapy defined as received in the adjuvant/neoadjuvant setting with recurrent or progressive disease within 12 months of completion OR received treatment with platinum in the locally advanced or metastatic setting
  • Must have had progression or recurrence during or following recept of most recent therapy
  • ECOG PS 0-1
  • Dose escalation cohorts must have available archival or fresh biopsy sample prior to study entry.  Others must have tumor accfessible for sequential biopsy and be willing to provide fresh pre-treatment and on-study tumor tissue biopsies
  • No pre-existing sensory or motor neuropathy Grade >/= 2
  • No symptomatic or unctrolled CNS metastases
  • No prior treatment with enfortumab vedotin
  • No prior treatment with any anti-CD47 or anti-SIRPa agent
  • No known uncontrolled HBV/HCV/HIV
  • No other malignancy within 3 years
  • No active autoimmune disease requiring treatment in last year
ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

PI

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
  • Must have tumor specimen available
  • Measurable disease
  • ECOG PS 0-1
  • Life expectancy at least 12 weeks
  • Phase 1a- must have exhausted all standard therapies for their disease
  • Phase 1b- must have disease that has progressed after at least one available standard therapy
  • Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
  • No active HBV/HCV or chronic or acute EBV
  • No history of autoimmune disease
  • No symptomatic or actively progressing CNS mets
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