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

NCT06741644 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CS2009-101
• Study Type: interventional
• Target: 660
• Locations: 2 countries
• Sites: 31

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

PD-1; VEGFA; CTLA4; tri-specific antibody; advanced solid tumors; Phase I

Outcome Measures

Primary Outcomes (4)

• [Dose Escalation] Maximum tolerated dose (MTD) of CS2009

  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).

  Cycle 1 (Up to 21 Days)

• [Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS2009

  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.

  Cycle 1 (Up to 21 Days)

• [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 Outcomes (7)

• [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

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Participants will be administered escalating doses of CS2009.

Drug: CS2009

Dose Expansion

EXPERIMENTAL

Participants will be administered the recommended dose(s) of CS2009 with or without chemotherapy according to dose-escalation data.

Drug: CS2009; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Etoposide; Drug: Nab-paclitaxel; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Docetaxel; Drug: Leucovorin; Drug: 5-FU; Drug: Cisplatin

Interventions

Carboplatin DRUG

IV infusion

Dose Expansion

Paclitaxel DRUG

IV infusion

Dose Expansion

Etoposide DRUG

IV infusion

Dose Expansion

Nab-paclitaxel DRUG

IV infusion

Dose Expansion

Oxaliplatin DRUG

IV infusion

Dose Expansion

Capecitabine DRUG

oral tablets

Dose Expansion

Docetaxel DRUG

IV infusion

Dose Expansion

Leucovorin DRUG

IV infusion

Dose Expansion

5-FU DRUG

IV infusion

Dose Expansion

Pemetrexed DRUG

IV infusion

Dose Expansion

Cisplatin DRUG

IV infusion

Dose Expansion

CS2009 DRUG

CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (31)

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

NOT YET 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

NOT YET 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

Zhengzhou, China

RECRUITING

MeSH Terms

Interventions

Pemetrexed; Carboplatin; Paclitaxel; Etoposide; 130-nm albumin-bound paclitaxel; Oxaliplatin; Capecitabine; Docetaxel; Leucovorin; Fluorouracil; Cisplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Coenzymes; Enzymes and Coenzymes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Jingru Wang

CONTACT

+86 18017113282; wangjingru@cstonepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (8); CN (23)