Title
A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation

Description
A Phase 1 Study of ASP3082 in Participants With Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation

Objective
Primary:
-To evaluate the safety and tolerability of ASP3082 monotherapy and ASP3082 combination therapy
-To determine the RP2D and/or the MTD of ASP3082 monotherapy and ASP3082 combination therapy

Secondary:
-To evaluate the anti-tumor effects
-To evaluate the pharmacokinetics of ASP3082
-To evaluate the effect on KRAS G12D level

Treatment Drug: ASP3082
Drug: Cetuximab
Drug: Leucovorin
Drug: Oxaplatin
Drug: Fluorouracil
Drug: Irinotecan
Drug: Nanoparticle albumin-bound-paclitaxel
Drug: Gemcitabine

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital