A Phase I Study of CS2009 in Participants With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: CS2009

• Registration Number: NCT06741644
• Lead Sponsor: CStone Pharmaceuticals

Brief 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 CS2009 in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-15
• Study First Posted: 2024-12-19
• Study Start: 2025-02-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

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.
• 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, or intolerance to standard of care.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	CS2009	Participants will be administered escalating doses of CS2009.
Dose Expansion	CS2009	Participants will be administered the recommended dose(s) of CS2009 according to dose-escalation data.

Primary Outcome Measures

Name	Time	Method
[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

Secondary Outcome Measures

Name	Time	Method
[Dose Escalation & Expansion] Area under the curve (AUC) of CS2009	Up to approximately 2 years
[Dose Escalation & Expansion] Maximum concentration (Cmax) of CS2009	Up to approximately 2 years
[Dose Escalation & Expansion] Elimination half-life (t1/2) of CS2009	Up to approximately 2 years
[Dose Escalation & Expansion] Minimum concentration (Cmin) of CS2009	Up to approximately 2 years
[Dose Escalation & Expansion] Number of participants with anti-CS2009 antibodies	Up to approximately 2 years
[Dose Escalation] Objective response rate (ORR) evaluated by investigators per RECIST v1.1	Up to approximately 2 years
[Dose Expansion] Number of participants with adverse events (AEs)	Up to approximately 2 years

Trial Locations

Locations (22)

Linyi Cancer Hospital; 🇨🇳 Linyi, China

Shanghai East Hospital; 🇨🇳 Shanghai, China

Alfred Hospital (Alfred Health); 🇦🇺 Melbourne, Australia

Austin Hospital (Austin Health); 🇦🇺 Melbourne, Australia

Monash Medical Centre (Monash Health); 🇦🇺 Melbourne, Australia

Icon Cancer Centre South Brisbane; 🇦🇺 South Brisbane, Australia

Blacktown Hospital; 🇦🇺 Sydney, Australia

Macquarie University Hospital; 🇦🇺 Sydney, Australia

Scientia Clinical Research Ltd; 🇦🇺 Sydney, Australia

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Jilin Cancer Hospital; 🇨🇳 Changchun, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Anhui Provincial Hospital; 🇨🇳 Hefei, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

Xuzhou Central Hospital; 🇨🇳 Xuzhou, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China