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

Launched by CONJUPRO BIOTHERAPEUTICS, INC. · Jul 10, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new drug called CPO301 for adults with advanced or metastatic solid tumors, including specific types of lung cancer. The main goals are to find out how safe the drug is at different doses and to see how well it works for patients. The study is split into two parts: the first part focuses on figuring out the best dose for the drug, while the second part looks specifically at its effects on patients with non-small cell lung cancer and other cancers.

To participate in the trial, you need to be at least 18 years old and have a confirmed diagnosis of advanced cancer that hasn't responded to previous treatments or for which no other treatments are available. Participants will receive the drug through an intravenous (IV) injection every three weeks and will have regular check-ups to monitor their health and the drug's effects. If you're considering joining, it's important to know that you'll need to meet certain health criteria and be willing to attend all study visits for up to two years. This trial is currently recruiting participants, and your involvement could help advance our understanding of new cancer treatments.

Gender

ALL

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 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.