A Phase I/II, 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, as Monotherapy and Combination Therapy in Participants With Advanced Solid Tumors

CStone Pharmaceuticals

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 establi…

Interventions

Drug
CS2009
CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
Drug
CS2009
CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 14/21-day cycles (Q2W/Q3W).
Drug
Pemetrexed
IV infusion
Drug
Carboplatin
IV infusion
Drug
Paclitaxel
IV infusion
Drug
Etoposide
IV infusion
Drug
Nab-paclitaxel
IV infusion
Drug
Oxaliplatin
IV infusion
Drug
Capecitabine
oral tablets
Drug
Docetaxel
IV infusion
Drug
Leucovorin
IV infusion
Drug
5-FU
IV infusion
Drug
Cisplatin
IV infusion
Drug
Gemcitabine
IV infusion
Drug
Irinotecan
IV infusion

Summary

Eligibility

Interventions

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