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

NCT05948865 · Conjupro Biotherapeutics, Inc.
In plain English

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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
About this study
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.
Eligibility 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.
Study design
Enrollment target: 132 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-06-06
Estimated completion: 2027-08
Last updated: 2026-03-20
Interventions
Drug: CPO301
Primary outcomes
  • To determine the dose to be used in Part B (RP2D) (through study completion, an average of 1 year)
  • Safety and tolerability at RP2D of CPO301 as monotherapy (through study completion, an average of 1 year)
Sponsor
Conjupro Biotherapeutics, Inc. · industry
Contacts & investigators
ContactKevin Romanko · contact · clinicaltrials.gov@cspcus.com · 609-686-6502
ContactAudrey Li · contact · clinicaltrials.gov@cspcus.com · 609-356-0210
All locations (14)
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
UCLA Hematology/Oncology - Santa MonicaRecruiting
Santa Monica, California, United States
Sarah Cannon Research Institute (SCRI) at HealthONERecruiting
Denver, Colorado, United States
AdventHealth Cancer InstituteRecruiting
Celebration, Florida, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Dartmouth Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
NEXT DallasRecruiting
Dallas, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
Cross Cancer InstituteRecruiting
Edmonton, Alberta, Canada
Juravinski Cancer CentreRecruiting
Hamilton, Ontario, Canada
Princess Margaret Cancer Centre - University Health NetworkRecruiting
Toronto, Ontario, Canada
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors · TrialPath