MC# 23-04 - A Phase I Study of ASP1002 in Participants with Metastatic or Locally Advanced Solid Tumors
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Agent(s): ASP1002
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Disease Type(s): Bladder, Colorectal, Ovarian, Prostate, Lung-NSCLC, Breast- Triple Negative
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Phase(s): I
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Drug Classification(s): Targeted Therapy, Bispecific Antibodies
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Molecular Target(s):
Mechanism of Action
Purpose
In this study, the sponsor and investigators want to learn:
- How much of ASP1002 can be given with an acceptable level of side effects
- The effects of ASP1002 (good and bad)
- How much of ASP1002 is absorbed into the blood and how fast it is removed
Inclusion Criteria
- Participant ≥ 18 years of age.
- Participant has locally-advanced (unresectable) or metastatic solid tumor which is confirmed by available pathology records or current biopsy.
- For dose escalation, the participant must have one of the following malignancies (for all tumor types, any component of neuroendocrine histology is exclusionary):
- NSCLC – adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded. Note: NSCLC Not Otherwise Specified will require medical monitor consultation prior to study entry.
- UC
- CRC
- Prostate adenocarcinoma
- Ovarian cancer
- TNBC
- For dose expansion, the participant must have one of the following malignancies (for all tumor types, any component of neuroendocrine histology is not eligible):
- NSCLC – adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded. Note: NSCLC Not Otherwise Specified will require medical monitor consultation prior to study entry.
- UC
- CRC
- Tumor type for which a confirmed response was observed during dose escalation
- For dose escalation, the participant must have one of the following malignancies (for all tumor types, any component of neuroendocrine histology is exclusionary):
- Participant has progressed, is intolerant, has refused, or there are no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
