CS2009: CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
CS2009: CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 14/21-day cycles (Q2W/Q3W).
Pemetrexed: IV infusion
Carboplatin: IV infusion
Paclitaxel: IV infusion
Etoposide: IV infusion
Nab-paclitaxel: IV infusion
Oxaliplatin: IV infusion
Capecitabine: oral tablets
Docetaxel: IV infusion
Leucovorin: IV infusion
5-FU: IV infusion
Cisplatin: IV infusion
Gemcitabine: IV infusion
Irinotecan: IV infusion
Study summary
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.
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.
* Age ≥ 18 years on the day of signing informed consent.
Phase I:
* Pathologically or cytologically confirmed, unresectable advanced solid tumors, including but not limited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), gastric cancer (GC), ovarian cancer (OC), cervical cancer (CC), etc.
* Failure of established standard of care for advanced disease, or no available standard of care.
Phase II:
* Pathologically or cytologically confirmed unresectable advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), etc.
* Participants with at least one measurable lesion as defined per RECIST v1.1 solid tumor.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function.
* Fertile male participants and female participants of childbearing potential must be willing to use an effective method of birth control from providing signed consent and for 180 days after the last investigational product administration.
* Female participants of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational product.
Exclusion Criteria:
* 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 either symptomatic, untreated, or requires therapy.
* Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 4 weeks prior to the first dose of investigational product.
* Receipt of systemic corticosteroid treatment or any other form of immune suppressing treatment within 7 days prior to the first dose of investigational product.
* Active or prior history of definite inflammatory bowel disease.
* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or presence of active or suspected ILD/pneumonitis.
* Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.
* Positive for human immunodeficiency virus (HIV) or presence of acquired immune deficiency syndrome (AIDS).
* Active Hepatitis B or C infection.
* Active pulmonary tuberculosis (TB).
* Major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the first dose of investigational product.
* Palliative radiotherapy within 14 days prior to the first dose of investigational product, or receipt of radioactive drug within 56 days prior to the first dose of investigational product.
* Administration of live vaccine within 28 days prior to the first dose of investigational product.
* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
* Receipt of antitumor Chinese herbal preparations or Chinese patent medicine within 7 days prior to the first dose of investigational product.
* Receipt of any other investigational drugs within 21 days prior to the first dose in this trial.
* History of hypersensitivity or idiosyncrasy to the excipients of the study drug or any monoclonal antibody.
* Any toxic effects of prior therapy or surgical procedures unresolved to baseline severity or NCI-CTCAE Version 5.0 Grade ≤ 1.
* Active alcohol or drug abuse.
* Female participants who are pregnant or breastfeeding.
* Other acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product administration.
Primary outcome measure(s)
[Dose Escalation] Maximum tolerated dose (MTD) of CS2009 — Cycle 1 (Up to 21 Days) 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).
[Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS2009 — Cycle 1 (Up to 21 Days) 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] Number of participants with 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 (33)
Facility
City
Region
Status
START Los Angeles, LLC
Los Angeles
California
Recruiting
NEXT Dallas
Irving
Texas
Recruiting
Alfred Hospital (Alfred Health)
Melbourne
Australia
Recruiting
Austin Hospital (Austin Health)
Melbourne
Australia
Recruiting
Monash Medical Centre (Monash Health)
Melbourne
Australia
Recruiting
Peter Maccallum Cancer Centre Research
Melbourne
Australia
Recruiting
Icon Cancer Centre South Brisbane
South Brisbane
Australia
Recruiting
Blacktown Hospital
Sydney
Australia
Recruiting
Macquarie University Hospital
Sydney
Australia
Recruiting
Scientia Clinical Research Ltd
Sydney
Australia
Recruiting
Beijing Cancer Hospital
Beijing
China
Recruiting
Jilin Cancer Hospital
Changchun
China
Recruiting
Hunan Cancer Hospital
Changsha
China
Recruiting
Sichuan Cancer Hospital
Chengdu
China
Recruiting
West China Hospital of Sichuan University
Chengdu
China
Recruiting
Fujian Cancer Hospital
Fuzhou
China
Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
China
Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou
China
Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
China
Not Yet Recruiting
Zhejiang Cancer Hospital
Hangzhou
China
Recruiting
Harbin Medical University Cancer Hospital
Harbin
China
Recruiting
Anhui Provincial Hospital
Hefei
China
Recruiting
Central Hospital Affiliated to Shandong First Medical University
Jinan
China
Recruiting
Linyi Cancer Hospital
Linyi
China
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
China
Recruiting
Nanjing Drum Tower Hospital
Nanjing
China
Recruiting
Fudan University Shanghai Cancer Center
Shanghai
China
Recruiting
Shanghai East Hospital
Shanghai
China
Recruiting
Shanghai Pulmonary Hospital
Shanghai
China
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
China
Recruiting
Xuzhou Central Hospital
Xuzhou
China
Recruiting
Henan Cancer Hospital
Zhengzhou
China
Recruiting
The First Affiliated Hospital of Zhengzhou University
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.