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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
310
CS5007 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
NOT_YET_RECRUITINGMacquarie University
North Ryde, New South Wales, Australia
RECRUITINGCalvary Mater Newcastle
Waratah, New South Wales, Australia
[Dose Escalation] Maximum tolerated dose (MTD) of CS5007
Participants will receive CS5007 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 CS5007
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: Up to approximately 2 years
[Dose Escalation] The incidence and severity of 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 CS5007
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Maximum concentration (Cmax) of CS5007
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Time to maximum concentration (Tmax) of CS5007
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Elimination half-life (t1/2) of CS5007
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.
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
RECRUITINGSt Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
NOT_YET_RECRUITINGLinear Clinical Research Ltd
Nedlands, Western Australia, Australia
RECRUITINGShanghai Chest Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITING[Dose Escalation & Expansion] Clearance (CL) of CS5007
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Volume of distribution (Vz) of CS5007
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Trough concentration (Ctrough) of CS5007
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Accumulation ratio (R) of CS5007
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Number of participants with anti-CS5007 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 Escalation & Expansion] Duration of response (DOR) evaluated by investigators per RECIST v1.1
Time frame: Up to approximately 2 years
[Dose Escalation & Expansion] Disease control rate (DCR) evaluated by investigators per RECIST v1.1
Time frame: Up to approximately 2 years
[Dose Expansion] The incidence and severity of adverse events (AEs)
Time frame: Up to approximately 2 years