CS5007 in people with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter Phase I trial of CS5007 given as monotherapy to adults with unresectable advanced solid tumors. The study uses a Phase Ia dose-escalation to identify a safe dose, followed by a Phase Ib dose-expansion to look for early signs of anti-tumor activity. Primary aims include safety, tolerability, and pharmacokinetics, with preliminary assessment of efficacy. Eligibility requires measurable disease, good performance status, adequate organ function, and life expectancy of at least three months. The trial is sponsored by CStone Pharmaceuticals with sites in Australia.

Why it matters

Who can join: the full rules

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.

Where it's running

• Macquarie University
  North Ryde, New South Wales, Australia Recruiting
• Calvary Mater Newcastle
  Waratah, New South Wales, Australia Recruiting
• Icon Cancer Centre South Brisbane
  South Brisbane, Queensland, Australia Recruiting
• Linear Clinical Research Ltd
  Nedlands, Western Australia, Australia Recruiting
• St Vincent's Hospital Sydney
  Darlinghurst, New South Wales, Australia Not yet recruiting
• St Vincent's Hospital Melbourne
  Fitzroy, Victoria, Australia Not yet recruiting

Study contacts

• Study coordinator: Sean Yao
• Email: yaosheng@cstonepharma.com
• Phone: +86 18616365940

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• AK157D1 injection for advanced solid tumors

  A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.

  Recruiting Phase 1 Akeso · Harbin, Heilongjiang and 2 other locations · NCT07847281

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• MK-2010 alone or with other treatments for advanced solid tumors

  This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.

  Recruiting at 7 sites Phase 2 Merck Sharp & Dohme LLC · Belleville, New Jersey and 6 other locations · NCT07793942

• Whole-Body Infrared Heating for Advanced Solid Tumors

  This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.

  Recruiting Zhejiang Hospital · Hangzhou, Zhejiang · NCT07793214

• MK-2010 with Sac-TMT in advanced solid tumors

  This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.

  Recruiting at 4 sites Phase 2 Merck Sharp & Dohme LLC · San Antonio, Texas and 3 other locations · NCT07785609

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.