Recruiting

Phase 1

CPO301A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors

Sponsor:

Conjupro Biotherapeutics, Inc.

Code:

NCT05948865

Conditions

Cancer

Cancer, Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CPO301

Study Details

Brief 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 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

Cancer

Cancer, Lung

Study ID

NCT05948865

Start date

Jun 6, 2023

Status verified date

Mar, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A, Dose Escalation

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.

experimental: Part B, Dose Expansion

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.

Interventions

CPO301

Administered by intravenous injection

Primary outcome measure

To determine the dose to be used in Part B (RP2D) [ Time Frame: through study completion, an average of 1 year ]
Safety and tolerability at RP2D of CPO301 as monotherapy [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Kevin Romanko

609-686-6502 clinicaltrials.gov@cspcus.com

Audrey Li

609-356-0210 clinicaltrials.gov@cspcus.com

Locations

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Jacob Thomas, MD

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92658

Principal Investigator:

Carlos R Becerra, MD

UCLA Hematology/Oncology - Santa Monica

Recruiting

Santa Monica, California, United States, 90404

Principal Investigator:

Lee S. Rosen, MD

Sarah Cannon Research Institute (SCRI) at HealthONE

Recruiting

Denver, Colorado, United States, 80218

Principal Investigator:

Gerald Falchook, MD, MS

AdventHealth Cancer Institute

Recruiting

Celebration, Florida, United States, 34747

Principal Investigator:

Guru P. Sonpavde, MD

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Principal Investigator:

Manish Patel, MD

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Principal Investigator:

Konstantin Dragnev, MD

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Principal Investigator:

Anshu Giri, MD

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Melissa L Johnson, MD

NEXT Dallas

Recruiting

Dallas, Texas, United States, 75039

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Alex Spira, MD

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Principal Investigator:

Quincy Chu, MD

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Principal Investigator:

Rosalyn Juergens, MD, PhD

Princess Margaret Cancer Centre - University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Principal Investigator:

Laswson Eng, MD

More Information

Sponsor

Conjupro Biotherapeutics, Inc.

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

Cancer
Non-Small Cell Lung Cancer
Solid Tumors
Metastatic
Advanced

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Conjupro Biotherapeutics, Inc. on 2026-03-20.