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

Part of paid clinical trials in Los Angeles, California.

Sponsor
CStone Pharmaceuticals
Study ID
NCT06741644
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
660 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

[Dose Escalation] Maximum tolerated dose (MTD) of CS2009 [ Time Frame: Cycle 1 (Up to 21 Days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
START Los Angeles, LLCLos AngelesCalifornia90025-
NEXT DallasIrvingTexas75039-

Find similar trials in Los Angeles, CA

By research site
START Los Angeles, LLC· Los Angeles, CANEXT Dallas· Irving, TX

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