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RECRUITING Phase 1

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

NCT05948865 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

Interventions

  • DRUG CPO301

Study Locations (14)

California

  • USC Norris Comprehensive Cancer Center — Los Angeles
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • UCLA Hematology/Oncology - Santa Monica — Santa Monica

Florida

  • AdventHealth Cancer Institute — Celebration
  • Florida Cancer Specialists — Sarasota

Ontario

  • Juravinski Cancer Centre — Hamilton
  • Princess Margaret Cancer Centre - University Health Network — Toronto

Colorado

  • Sarah Cannon Research Institute (SCRI) at HealthONE — Denver

New Hampshire

  • Dartmouth Hitchcock Medical Center — Lebanon

Pennsylvania

  • Fox Chase Cancer Center — Philadelphia

Tennessee

  • SCRI Oncology Partners — Nashville

Texas

  • NEXT Dallas — Dallas

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2023-06-06
Est. Completion 2027-08
Phase Phase 1

Sponsor

Conjupro Biotherapeutics

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05948865

The ClinicalTrials.gov registry entry for NCT05948865 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Conjupro Biotherapeutics, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention — of which CPO301 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05948865 reports 14 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05948865 about?

NCT05948865 is a clinical study titled "A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors". 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 ...

What is the current status of trial NCT05948865?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2023-06-06. Estimated completion is 2027-08.

What conditions does trial NCT05948865 study?

This clinical trial studies the following conditions: Cancer, Cancer, Lung. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05948865?

The interventions under investigation include: CPO301 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05948865?

This trial is sponsored by Conjupro Biotherapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05948865 being conducted?

This trial has 14 study locations across California, Colorado, Florida, New Hampshire, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial