A Phase I Study of CS5007 in Participants With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
CS5007: CS5007 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
Study summary
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
Primary outcome measure(s)
- [Dose Escalation] Maximum tolerated dose (MTD) of CS5007 — Cycle 1 (Up to 21 Days)
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). - [Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS5007 — Up to approximately 2 years
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. - [Dose Escalation] The incidence and severity of adverse events (AEs) — Up to approximately 2 years
- [Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1 — Up to approximately 2 years
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | Not Yet Recruiting |
| Macquarie University | North Ryde | New South Wales | Recruiting |
| Calvary Mater Newcastle | Waratah | New South Wales | Recruiting |
| Icon Cancer Centre South Brisbane | South Brisbane | Queensland | Recruiting |
| St Vincent's Hospital Melbourne | Fitzroy | Victoria | Not Yet Recruiting |
| Linear Clinical Research Ltd | Nedlands | Western Australia | Recruiting |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | Not Yet Recruiting |
More CStone Pharmaceuticals trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07622524 on ClinicalTrials.gov ↗ ← All trials in China