A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Conjupro Biotherapeutics, Inc.
Study ID
NCT05948865
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cancer
  • Cancer, Lung

Eligibility Criteria

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

Interventions

  • CPO301 — DRUG
    Administered by intravenous injection

Study Details

The goal of this clinical trial is to test CPO301, a type of drug called an antibody drug conjugate in adult patients with advanced or metastatic solid tumors. The main questions it aims to answer are: * To assess the safety and tolerability of CPO301 at increasing doses and determine the dose to be used in the second part of the study (Part A) * To assess the safety and tolerability of CPO301 at the dose determined to be safe and tolerable in Part A in patients with Non-Small Cell Lung Cancer and potentially other tumor types (Part B) * To evaluate how quickly CPO301 is metabolized by the body (pharmacokinetics or PK) * To evaluate if antibodies to the study drug develop (immunogenicity) * To evaluate preliminary efficacy to the drug * To correlate preliminary efficacy with mutations in a biomarker called EGFR Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive CPO301 by intravenous injection every 3 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment * Be followed for progression every 3 months for up to 2 years

Key Dates

Start date
Jun 6, 2023
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Aug 31, 2027

Study Design

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

Arms

  • Experimental: Part A, Dose Escalation
    Participants receive escalating doses of CPO301 of 0.6 mg/kg, 1.8mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.4 mg/kg and 8 mg/kg administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle.
  • Experimental: Part B, Dose Expansion
    Participants receive CPO301 at the recommended phase 2 dose (RP2D) determined in Part A, administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle.

Primary Outcome Measure

To determine the dose to be used in Part B (RP2D) [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Jacob Thomas, MD (PRINCIPAL_INVESTIGATOR)
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92658
Carlos R Becerra, MD (PRINCIPAL_INVESTIGATOR)
UCLA Hematology/Oncology - Santa MonicaSanta MonicaCalifornia90404
Lee S. Rosen, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute (SCRI) at HealthONEDenverColorado80218
Gerald Falchook, MD, MS (PRINCIPAL_INVESTIGATOR)
AdventHealth Cancer InstituteCelebrationFlorida34747
Guru P. Sonpavde, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsSarasotaFlorida34232
Manish Patel, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756
Konstantin Dragnev, MD (PRINCIPAL_INVESTIGATOR)
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Anshu Giri, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Melissa L Johnson, MD (PRINCIPAL_INVESTIGATOR)
NEXT DallasDallasTexas75039
Shiraj Sen, MD
NEXT VirginiaFairfaxVirginia22031
Alex Spira, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAHoag Memorial Hospital Presbyterian· Newport Beach, CAUCLA Hematology/Oncology - Santa Monica· Santa Monica, CASarah Cannon Research Institute (SCRI) at HealthONE· Denver, COAdventHealth Cancer Institute· Celebration, FLFlorida Cancer Specialists· Sarasota, FL

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