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

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

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

Sponsors & Collaborators

• CStone Pharmaceuticals

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-24

Primary Completion

2027-01-31

Completion

2028-01-31

FDA Drug

Yes

Countries

• Australia
• China

Study Locations