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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06741644




Registration number
NCT06741644
Ethics application status
Date submitted
15/12/2024
Date registered
19/12/2024
Date last updated
7/03/2025

Titles & IDs
Public title
A Phase I Study of CS2009 in Participants With Advanced Solid Tumors
Scientific title
A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS2009, a Tri-specific Antibody Targeting PD-1/VEGFA/CTLA-4, in Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
CS2009-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CS2009

Experimental: Dose Escalation - Participants will be administered escalating doses of CS2009.

Experimental: Dose Expansion - Participants will be administered the recommended dose(s) of CS2009 according to dose-escalation data.


Treatment: Drugs: CS2009
CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
[Dose Escalation] Maximum tolerated dose (MTD) of CS2009
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
Cycle 1 (Up to 21 Days)
Primary outcome [2] 0 0
[Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS2009
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Cycle 1 (Up to 21 Days)
Primary outcome [3] 0 0
[Dose Escalation] Number of participants with adverse events (AEs)
Assessment method [3] 0 0
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
[Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1
Assessment method [4] 0 0
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
[Dose Escalation & Expansion] Area under the curve (AUC) of CS2009
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
[Dose Escalation & Expansion] Maximum concentration (Cmax) of CS2009
Assessment method [2] 0 0
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
[Dose Escalation & Expansion] Elimination half-life (t1/2) of CS2009
Assessment method [3] 0 0
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
[Dose Escalation & Expansion] Minimum concentration (Cmin) of CS2009
Assessment method [4] 0 0
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
[Dose Escalation & Expansion] Number of participants with anti-CS2009 antibodies
Assessment method [5] 0 0
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
[Dose Escalation] Objective response rate (ORR) evaluated by investigators per RECIST v1.1
Assessment method [6] 0 0
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
[Dose Expansion] Number of participants with adverse events (AEs)
Assessment method [7] 0 0
Timepoint [7] 0 0
Up to approximately 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2028
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Hospital (Alfred Health) - Melbourne
Recruitment hospital [2] 0 0
Austin Hospital (Austin Health) - Melbourne
Recruitment hospital [3] 0 0
Monash Medical Centre (Monash Health) - Melbourne
Recruitment hospital [4] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [5] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [6] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [7] 0 0
Scientia Clinical Research Ltd - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- South Brisbane
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Changchun
Country [3] 0 0
China
State/province [3] 0 0
Chengdu
Country [4] 0 0
China
State/province [4] 0 0
Fuzhou
Country [5] 0 0
China
State/province [5] 0 0
Guangzhou
Country [6] 0 0
China
State/province [6] 0 0
Hangzhou
Country [7] 0 0
China
State/province [7] 0 0
Harbin
Country [8] 0 0
China
State/province [8] 0 0
Hefei
Country [9] 0 0
China
State/province [9] 0 0
Linyi
Country [10] 0 0
China
State/province [10] 0 0
Shanghai
Country [11] 0 0
China
State/province [11] 0 0
Wuhan
Country [12] 0 0
China
State/province [12] 0 0
Xuzhou
Country [13] 0 0
China
State/province [13] 0 0
Zhengzhou

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CStone Pharmaceuticals
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jingru Wang
Address 0 0
Country 0 0
Phone 0 0
+86 18017113282
Email 0 0
wangjingru@cstonepharma.comnepharma.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06741644