A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas

Part of paid clinical trials in East Setauket, New York.

Sponsor
CStone Pharmaceuticals
Study ID
NCT05279300
Phase
PHASE1
Status
Suspended

Conditions

  • Advanced Lymphoma
  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • CS5001 — DRUG
    The dose and dosing schedule is decided by the Safety Monitoring Committee.
  • Rituximab — BIOLOGICAL
    IV infusion
  • Gemcitabine — DRUG
    IV infusion
  • Oxaliplatin — DRUG
    IV infusion
  • Lenalidomide — DRUG
    PO
  • Cyclophosphamide — DRUG
    IV infusion
  • Doxorubicin — DRUG
    IV infusion
  • Vincristine — DRUG
    IV infusion
  • Prednisone — DRUG
    PO

Study Details

This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug CS5001 used as a single agent and in combination with systemic therapies in patients with advanced hematological and solid tumors.

Key Dates

First listed
Mar 15, 2022
Start date
Mar 28, 2022
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Dose escalation
  • Experimental: Dose expansion

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part) [ Time Frame: About 6 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
North Shore Hematology Oncology AssociatesEast SetauketNew York11733-
Columbia U. - Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
BUMC - Mary Crowley Cancer Research Centers (MCCRC)DallasTexas75201-7307-

Find similar trials in East Setauket, NY

By research site
North Shore Hematology Oncology Associates· East Setauket, NYColumbia U. - Herbert Irving Comprehensive Cancer Center· New York, NYBUMC - Mary Crowley Cancer Research Centers (MCCRC)· Dallas, TX

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