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Recruiting Phase 1

A Phase I Study of CS5007 in Participants With Advanced Solid Tumors

NCT07622524 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2026-07-16
Last updated
2026-08-14

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

CS5007

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. * Participants must have at least one measurable lesion according to RECIST Version1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1. * Adequate organ function. * Life expectancy ≥ 3 months. * Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration Exclusion Criteria: * 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. * Has uncontrolled pleural effusion, pericardial effusion, or ascites. * Has immune deficient disease or received systemic immunosuppressive treatment. * Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea. * Has history of (non-infectious) interstitial lung disease/pneumonitis that required steroids. * Has active infections requiring systemic therapy. * Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose. * Insufficient washout from prior anti-tumor therapy. * Received live vaccine within 28 days prior to first dose. * History of allogeneic organ or hematopoietic stem cell transplantation. * History of hypersensitivity to excipients of study drug or any monoclonal antibody. * Any toxic effects of prior therapy unresolved to Grade ≤1. * Active alcohol or drug abuse. * Pregnant or breastfeeding women. * Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.

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)

FacilityCityRegionStatus
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
Official registry record

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