A Phase I Study of CS5007 in Participants With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCStone Pharmaceuticals
About this trial
This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.
Eligibility criteria
Qualifiers
Evidence of a personally signed and dated informed consent document.
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Being ≥ 18 years of age on the day of signing informed consent.
Pathologically or cytologically confirmed, unresectable advanced solid tumors.
Disqualifiers
Has disease that is suitable for local treatment administered with curative intent.
Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy.
Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose.
Trial design
Treatments tested in this trial
- CS5007
Treatment groups
310 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov