No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
Conjupro Biotherapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adult patients with advanced solid tumors to test a new drug called CPO301. Participants will receive the drug through an injection every 3 weeks and will be monitored for their health and any possible side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have advanced or metastatic solid tumors that are getting worse.
I have received treatments before but cannot continue them.
I have at least one measurable tumor documented by imaging.
I have an ECOG performance status of 0 or 1.
I expect to live more than 12 weeks.
I have a solid tumor type that fits the trial criteria.
You may not be able to join if
I have uncontrolled brain cancer or meningitis.
I have not fully recovered from side effects of previous treatments.
I have a serious illness that could interfere with the study.
I received other investigational drugs within 4 weeks of starting this study.
I had major surgery within the last 4 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 a…
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
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.