Recruiting
Phase 1
Phase 2

CS2009

Sponsor:

CStone Pharmaceuticals

Code:

NCT06741644

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CS2009

CS2009

Pemetrexed

Carboplatin

Paclitaxel

Study Details

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

Study ID

NCT06741644

Start date

Feb 24, 2025

Status verified date

Aug, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

800 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

Participants will be administered escalating doses of CS2009.

experimental: Dose Expansion

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

Interventions

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

Primary outcome measure

  • [Dose Escalation] Maximum tolerated dose (MTD) of CS2009 [ Time Frame: Cycle 1 (Up to 21 Days) ]
  • [Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS2009 [ Time Frame: Cycle 1 (Up to 21 Days) ]
  • [Dose Escalation] Number of participants with adverse events (AEs) [ Time Frame: Up to approximately 2 years ]
  • [Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1 [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Jingru Wang

+86 18017113282wangjingru@cstonepharma.com

Locations

START Los Angeles, LLC

Recruiting

Los Angeles, California, United States, 90025

NEXT Dallas

Recruiting

Irving, Texas, United States, 75039

More Information

Sponsor

CStone Pharmaceuticals

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CStone Pharmaceuticals on 2026-08-20.