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Phase 1 Study of CPO301 for Advanced Solid Tumors

This study is testing a drug called CPO301 in adults with advanced or metastatic (spread to other parts of the body) solid tumors. CPO301 is an antibody drug conjugate, which is a type of targeted therapy and immunotherapy. The main goals are to find a safe and tolerable dose of CPO301, understand how it works in the body, and see if it has any early effects on the cancer. You may be able to join if your cancer has progressed, you can't tolerate other treatments, or you're not eligible for standard care. This study is currently recruiting 132 participants.

Study design
This is a Phase 1 study with two parts, involving increasing doses of CPO301 to find the best dose, followed by testing that dose in more patients. It is a single-arm study, meaning all participants will receive CPO301.
What's involved
Participants will receive CPO301 through intravenous injection. The study will involve monitoring for side effects and how the drug is processed by the body.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05948865

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Conjupro Biotherapeutics, Inc.
~132 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:CPO301

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the dose to be used in Part B (RP2D)
Measured over through study completion, an average of 1 year
+1 more outcome measured

Conditions

Cancer
Cancer, Lung

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Lung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

14 sites across 10 states
California3
Florida2
Ontario2
Colorado1
New Hampshire1
Pennsylvania1
Tennessee1
Texas1

Who to contact

Kevin Romanko
[email protected]
609-686-6502
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
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.

What this trial measures

  • To determine the dose to be used in Part B (RP2D)through study completion, an average of 1 year

    To determine the recommended dose of CPO301 to be used as monotherapy in Part B (RP2D)

  • Safety and tolerability at RP2D of CPO301 as monotherapythrough study completion, an average of 1 year

    as measured by Incidence and severity of AEs per CTCAEv5.0