Actively Recruiting
A Phase 1 Study Evaluating Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of CPO301 in Adults With Advanced or Metastatic Solid Tumors
Led by Conjupro Biotherapeutics, Inc. · Updated on 2026-03-20
132
Participants Needed
14
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CPO301, an antibody drug conjugate, in adults with advanced or metastatic solid tumors who have progressed on prior treatments or are ineligible for standard therapy. This Phase 1 trial aims to assess the safety, tolerability, and optimal dosing of CPO301, as well as its pharmacokinetics, immunogenicity, and preliminary effectiveness, including its relationship to EGFR biomarker mutations. The study is sponsored by Conjupro Biotherapeutics, Inc. The trial has two parts. In Part A, patients receive escalating doses of CPO301 by intravenous injection every three weeks to identify the maximum tolerated dose or recommended phase 2 dose. In Part B, additional patients receive CPO301 at the dose determined safe and tolerable in Part A, focusing on those with non-small cell lung cancer with EGFR mutations and other tumor types. Treatment cycles last 21 days, and dose adjustments may be made based on safety assessments. Participants will provide informed consent, undergo screening to confirm eligibility, and attend study visits to receive CPO301 every three weeks until the study doctor decides to stop treatment. Researchers will monitor participants for disease progression every three months for up to two years. Safety, drug metabolism, immune response, and preliminary antitumor activity will be evaluated throughout the study, which is expected to last about one year for the primary outcomes.
CONDITIONS
Brief Title
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed locally advanced or metastatic solid tumors with disease progression, intolerance to prior therapy, ineligibility, or refusal of standard care
- In Part A, patients with solid tumors including NSCLC, breast cancer, KRAS-wild type colorectal cancer, and head & neck cancer
- In Part B, NSCLC patients with documented EGFR mutations and patients with other tumors showing sensitivity to CPO301
- At least 1 measurable target lesion documented by CT or MRI according to RECIST v1.1
- ECOG performance status 0 or 1 at screening
- Life expectancy greater than 12 weeks
You will not qualify if you...
- Known, active, or uncontrolled central nervous system metastasis or carcinomatous meningitis
- Adverse events from previous anti-tumor treatments not recovered to Grade 1 or lower (except alopecia; some Grade 2 chronic toxicities may be excluded after consultation)
- Any serious or uncontrolled illness that may interfere with study participation
- Receipt of other investigational drugs or treatments within 4 weeks before the first dose
- Anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or investigational drugs within 4 weeks before the first dose
- Oral fluoropyrimidines or small molecule targeted drugs within 2 weeks before the first dose
- Palliative radiotherapy or local therapy within 2 weeks before the first dose
- Major surgery within 4 weeks before the first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until dose escalation decisions are made
Participants receive escalating doses of CPO301 to determine the maximum tolerated dose and recommended dose.
Visits every 3 weeks for dosing and assessments during each 21-day treatment cycle
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive CPO301 at the recommended phase 2 dose determined in the dose escalation stage.
Visits every 3 weeks for dosing and assessments during each 21-day treatment cycle
Trial Site Locations
Total: 14 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Actively Recruiting
3
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States, 90404
Actively Recruiting
4
Sarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
5
AdventHealth Cancer Institute
Celebration, Florida, United States, 34747
Actively Recruiting
6
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
7
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
8
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
9
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
NEXT Dallas
Dallas, Texas, United States, 75039
Actively Recruiting
11
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
13
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
14
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
K
Kevin Romanko
A
Audrey Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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