CancerPhase 1NCT05948865
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing CPO301 in people with Cancer and Cancer, Lung, run by Conjupro Biotherapeutics, Inc. at 14 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer, Lung
- What is being tested?
- CPO301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 6 Jun 2023to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
AdventHealth Cancer Institute
Celebration, Florida, 34747
Guru P. Sonpavde, MD
- Recruiting
NEXT Dallas
Dallas, Texas, 75039
Shiraj Sen, MD
- Recruiting
Sarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado, 80218
Gerald Falchook, MD, MS
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Alex Spira, MD
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Konstantin Dragnev, MD
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Jacob Thomas, MD
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Melissa L Johnson, MD
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Carlos R Becerra, MD
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Anshu Giri, MD
- Recruiting
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
Lee S. Rosen, MD
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
Manish Patel, MD
Canada3 sites, 3 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Quincy Chu, MD
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Rosalyn Juergens, MD, PhD
- Recruiting
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, M5G 2M9
Laswson Eng, MD
About this study
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
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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Cancer, Cancer, Lung
- Being tested
- CPO301
- Keywords
- Cancer, Non-Small Cell Lung Cancer, Solid Tumors, Metastatic, Advanced
- Medical subject headings
- Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPO301Drug
Also called SYS6010
Administered by intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Part A, Dose Escalation | Experimental | Participants receive escalating doses of CPO301 of 0.6 mg/kg, 1.8mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.4 mg/kg and 8 mg/kg administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle. Receives: Drug: CPO301 |
| Part B, Dose Expansion | Experimental | Participants receive CPO301 at the recommended phase 2 dose (RP2D) determined in Part A, administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle. Receives: Drug: CPO301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the dose to be used in Part B (RP2D)
To determine the recommended dose of CPO301 to be used as monotherapy in Part B (RP2D)
Measured: through study completion, an average of 1 year
Safety and tolerability at RP2D of CPO301 as monotherapy
as measured by Incidence and severity of AEs per CTCAEv5.0
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Pharmacokinetics (PK)
The pharmacokinetics (PK) profile of CPO301 will be assessed by measuring the blood concentration of the drug in the plasma at various timepoints and calculation of parameters, such as Peak Plasma Concentration (Cmax)
Measured: through study completion, an average of 1 year
Expression of anti-drug antibody (ADA)
The expression of anti-drug antibodies (ADAs) following administration will be assessed by analysis of serum samples.
Measured: through study completion, an average of 1 year
Efficacy assessment
To document any early indication of clinical efficacy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start6 Jun 2023
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Conjupro Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948865
- Sponsor's protocol ID
- CPO301-US-101
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05948865
- Acronym / sponsor ID
- CPO301-US-101
- Conditions
- Cancer, Cancer, Lung
- Keywords
- Cancer, Non-Small Cell Lung Cancer, Solid Tumors, Metastatic, Advanced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Conjupro Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A, Dose Escalation | Experimental | Drug: CPO301Participants receive escalating doses of CPO301 of 0.6 mg/kg, 1.8mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.4 mg/kg and 8 mg/kg administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle. |
| Part B, Dose Expansion | Experimental | Drug: CPO301Participants receive CPO301 at the recommended phase 2 dose (RP2D) determined in Part A, administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPO301Also: SYS6010Administered by intravenous injection | Drug | Part A, Dose Escalation, Part B, Dose Expansion |
Primary outcome
To determine the dose to be used in Part B (RP2D)
Time frame: 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 monotherapy
Time frame: through study completion, an average of 1 year
as measured by Incidence and severity of AEs per CTCAEv5.0
3 secondary outcomes
Pharmacokinetics (PK)
Time frame: through study completion, an average of 1 year
Expression of anti-drug antibody (ADA)
Time frame: through study completion, an average of 1 year
Efficacy assessment
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPO301 in people with Cancer and Cancer, Lung, run by Conjupro Biotherapeutics, Inc. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Romanko (609-686-6502, clinicaltrials.gov@cspcus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the dose to be used in Part B (RP2D) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.