This is a first-in-human (FIH), open-label, and multi-center Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 as Monotherapy and Combination Therapy in Participants with Advanced Solid Tumors. The study is comprised of a Phase I dose escalation and Phase II dose expansion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 14/21-day cycles (Q2W/Q3W).
IV infusion
[Dose Escalation] Maximum tolerated dose (MTD) of CS2009
Participants will receive CS2009 via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W). The MTD will be determined, if any, by the number of participants who experience a dose limiting toxicity (DLT).
Time frame: Cycle 1 (Up to 21 Days)
[Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS2009
The selection of tentative RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The tentative RP2D may be the MTD or a lower dose within the tolerable dose range.
Time frame: Cycle 1 (Up to 21 Days)
[Dose Escalation] Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 years
[Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Area under the curve (AUC) of CS2009
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Maximum concentration (Cmax) of CS2009
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Elimination half-life (t1/2) of CS2009
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Minimum concentration (Cmin) of CS2009
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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oral tablets
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START Los Angeles, LLC
Los Angeles, California, United States
RECRUITINGNEXT Dallas
Irving, Texas, United States
RECRUITINGAlfred Hospital (Alfred Health)
Melbourne, Australia
RECRUITINGAustin Hospital (Austin Health)
Melbourne, Australia
RECRUITINGMonash Medical Centre (Monash Health)
Melbourne, Australia
RECRUITINGPeter Maccallum Cancer Centre Research
Melbourne, Australia
RECRUITINGIcon Cancer Centre South Brisbane
South Brisbane, Australia
RECRUITINGBlacktown Hospital
Sydney, Australia
RECRUITINGMacquarie University Hospital
Sydney, Australia
RECRUITINGScientia Clinical Research Ltd
Sydney, Australia
RECRUITING...and 23 more locations
[Dose Escalation & Expansion] Number of participants with anti-CS2009 antibodies
Time frame: Up to approximately 2 years
[Dose Escalation] Objective response rate (ORR) evaluated by investigators per RECIST v1.1
Time frame: Up to approximately 2 years
[Dose Expansion] Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 years