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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05948865
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Conjupro Biotherapeutics, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Cancer Cancer, Lung Drug: CPO301 Phase 1

Detailed Description:

This Phase 1 study is a multicenter, dose-escalating, dose-expansion, single agent, 2-part study conducted in patients with advanced or metastatic solid tumors who progressed on ≥1 prior conventional systemic therapy or who were ineligible or intolerant to standard treatment or had no or refused standard treatment.

Dose escalation (Part A) - Dose escalation will be guided by a modified 3+3 design to determine the maximum tolerated dose (MTD) or recommended dose of CPO301 (also known as SYS6010). Determination of dose-limiting toxicity (DLT) will be based on toxicity observed during the DLT observation period (first 21 days [1 cycle]). Dose escalation decisions are made based on the occurrence of DLT. MTD will be determined based on the data of all enrolled participants. To better identify the MTD, one or more dose groups may also be added beyond the planned maximum dose group (if determined to be safe), or between the maximum escalation dose group and the next lower dose group for DLT assessment. Intermediate dose groups and/or adjustment to the dosing frequency may be made

Dose expansion (Part B) - Additional patients will be enrolled at the recommended dose determined in the dose escalation stage. An additional tumor cohort may be added based on data observed in Part A.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO301, an EGFR-Targeting Antibody-Drug Conjugate, in Adult Patients With Advanced or Metastatic Solid Tumors
Actual Study Start Date : June 6, 2023
Estimated Primary Completion Date : June 13, 2025
Estimated Study Completion Date : December 12, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: CPO301
Administered by intravenous injection
Other Name: SYS6010

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.
Drug: CPO301
Administered by intravenous injection
Other Name: SYS6010




Primary Outcome Measures :
  1. To determine the dose to be used in Part B (RP2D) [ Time Frame: through study completion, an average of 1 year ]
    To determine the recommended dose of CPO301 to be used as monotherapy in Part B (RP2D)

  2. Safety and tolerability at RP2D of CPO301 as monotherapy [ Time Frame: through study completion, an average of 1 year ]
    as measured by Incidence and severity of AEs per CTCAEv5.0


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) [ Time Frame: through study completion, an average of 1 year ]
    The pharmacokinetics (PK) profile of CPO301 will be assessed by measuring the blood concentration of the drug in the plasma at various timepoints and calculation of parameters, such as Peak Plasma Concentration (Cmax)

  2. Expression of anti-drug antibody (ADA) [ Time Frame: through study completion, an average of 1 year ]
    The expression of anti-drug antibodies (ADAs) following administration will be assessed by analysis of serum samples.

  3. Efficacy assessment [ Time Frame: through study completion, an average of 1 year ]
    To document any early indication of clinical efficacy


Other Outcome Measures:
  1. Parts A and B, Exploratory: Correlatives [ Time Frame: through study completion, an average of 1 year ]
    To explore the correlation between EGFR status (different mutations, or amplification levels) and efficacy in patients with advanced solid tumors and biomarkers relevant to CPO301 efficacy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • Age ≥18 years
  • Patients with histologically confirmed locally advanced or metastatic solid tumors who have disease progression, intolerance to prior therapy, are ineligible for available therapies, or refuse standard of care therapy in the metastatic setting.
  • In Part A, patients with solid tumors including but not limited to NSCLC (adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type colorectal cancer, and head & neck cancer based on previous biopsy result.
  • In Part B, Cohort 1 will exclusively include NSCLC patients with documented EGFR mutations based on previous biopsy result and Cohort 2 will be patients with other cancer(s) suggested to have sensitivity to CPO301 in Part A.
  • At least 1 measurable target lesion present and documented by CT or MRI according to RECIST v1.1
  • ECOG performance status 0 or 1 at screening
  • Life expectancy >12 weeks

Major Exclusion Criteria:

  • Known, active, or uncontrolled central nervous system (CNS) metastasis or carcinomatous meningitis.
  • Has AEs due to previous anti-tumor treatments not recovered to ≤Grade 1 (except for alopecia; some tolerable chronic toxicities of Grade 2 may be excluded after consultation with the sponsor, as judged by the investigator) according to NCI-CTCAE v5.0.
  • Any serious and/or uncontrolled concurrent illness that may interfere with study participation

Prior therapy

  • Received other investigational drugs or treatments within 4 weeks before the first dose of the investigational drug in the study
  • The time interval between the latest anti-tumor treatment and the first dose of the investigational drug meets the following requirements: Have received anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy and other clinical investigational drugs within 4 weeks before the first dose of the investigational drug; have received oral fluoropyrimidines, small molecule targeted drugs within 2 weeks before the first dose of the investigational drug; have received palliative radiotherapy or local therapy within 2 weeks before the first dose of investigational drug.
  • Had major surgery within 4 weeks before the first dose of the investigational drug in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05948865


Contacts
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Contact: Kevin Romanko 609-686-6502 clinicaltrials.gov@cspcus.com
Contact: Audrey Li 609-356-0210 clinicaltrials.gov@cspcus.com

Locations
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United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Jacob Thomas, MD         
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92658
Principal Investigator: Carlos R Becerra, MD         
UCLA Hematology/Oncology - Santa Monica Recruiting
Santa Monica, California, United States, 90404
Principal Investigator: Lee S. Rosen, MD         
United States, Colorado
Sarah Cannon Research Institute (SCRI) at HealthONE Recruiting
Denver, Colorado, United States, 80218
Principal Investigator: Gerald Falchook, MD, MS         
United States, Florida
AdventHealth Cancer Institute Recruiting
Celebration, Florida, United States, 34747
Principal Investigator: Guru P. Sonpavde, MD         
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
Principal Investigator: Manish Patel, MD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Principal Investigator: Anshu Giri, MD         
United States, Tennessee
SCRI Oncology Partners Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Melissa L Johnson, MD         
United States, Virginia
NEXT Virginia Recruiting
Fairfax, Virginia, United States, 22031
Principal Investigator: Alex Spira, MD         
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Principal Investigator: Rosalyn Juergens, MD, PhD         
Sponsors and Collaborators
Conjupro Biotherapeutics, Inc.
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Responsible Party: Conjupro Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05948865    
Other Study ID Numbers: CPO301-US-101
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Conjupro Biotherapeutics, Inc.:
Cancer
Non-Small Cell Lung Cancer
Solid Tumors
Metastatic
Advanced
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases