A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
18 Years and older, Male and Female
BP44474 (primary)
NCI-2023-06836
2023-503170-20-00
2023-503170-20-01
Summary
This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose
expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,
and preliminary anti-tumor activity of RO7589831 monotherapy, and in combination with
pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient
mismatch repair (dMMR) advanced solid tumors. RO7589831 is an oral drug that acts on a
protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or
dMMR. By acting on WRN, RO7589831 may be able to block the growth of these types of
cancer.
Eligibility
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Have a microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor; for the combination with pembrolizumab only: Histologically confirmed locally advanced, or metastatic colorectal adenocarcinoma (CRC) with no prior systemic treatment for metastatic disease and not amenable to surgery
- Have received and then progressed following, or are intolerant to, standard therapy in the advanced setting
- Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Life expectancy of at least (=)12 weeks
- Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing; for participants without archival tissue, a biopsy from either primary or metastatic tumor lesion, deemed medically feasible, must be taken
- Adequate hematologic, end-organ, and cardiovascular function, as defined in the protocol
Treatment Sites in Georgia
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