Actively Recruiting
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
Led by Conjupro Biotherapeutics, Inc. · Updated on 2026-03-20
132
Participants Needed
14
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 for available therapies, or refusal of standard care in metastatic setting
- In Part A, solid tumors including NSCLC (adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type colorectal cancer, and head & neck cancer
- In Part B, Cohort 1 includes NSCLC patients with documented EGFR mutations; Cohort 2 includes other cancers suggested to be sensitive 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 less (except alopecia); some Grade 2 chronic toxicities may be excluded after sponsor consultation
- Any serious or uncontrolled concurrent illness that may interfere with participation
- Received other investigational drugs or treatments within 4 weeks before first dose
- Received chemotherapy, radiotherapy, targeted therapy, immunotherapy, or clinical investigational drugs within 4 weeks before first dose
- Received oral fluoropyrimidines or small molecule targeted drugs within 2 weeks before first dose
- Received palliative radiotherapy or local therapy within 2 weeks before first dose
- Had major surgery within 4 weeks before first dose
AI-Screening
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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
CONTACT
A
Audrey Li
CONTACT
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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