Dose Escalation and Dose Expansion Study of CPO-100 in Patients With Advanced Solid Tumors (NCT04931823) | Clinical Trial Compass
TerminatedPhase 1
Dose Escalation and Dose Expansion Study of CPO-100 in Patients With Advanced Solid Tumors
Stopped: Business Decision
United States34 participantsStarted 2021-03-24
Plain-language summary
This is a Phase 1, multicenter, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) in adult patients with advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Presence of a pathologically documented (histology or cytology) locally advanced or metastatic solid tumor cancer.
✓. Patients has failed at least 2 lines of conventional systemic therapy or have no other standard of care therapies available for their cancer. Prostate cancer patients should have received adenosine triphosphate (ADT) alone,(GnRH agonist, GnRH antagonist, or surgical orchiectomy and a pathway targeted agent such as abiraterone, enzalutamide, etc (castration-resistant prostate cancer). M1 disease must be present (not just biochemical recurrence).
✓. Male or female patients18 years of age or older.
✓. ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0, 1 or 2
✓. Having at least one measurable target lesion present and documented by RECIST 1.1 for each cancer other than prostate cancer. Patients with prostate cancer may be enrolled with non-measurable disease providing the patient with a prostate-specific antigen (PSA) increase that is ≥25% and ≥2 ng/mL above the nadir, which is confirmed by a second value ≥3 weeks later, or 2 or more new bone lesions on imaging.
✓. Adequate major system function defined as:
✓. Bone marrow reserve:
✓. Hepatic function:
Exclusion criteria
✕. Most recent chemotherapy ≤14 days or have residual NCI CTCAE greater than Grade 1 chemotherapy-related side effects, with the exception of alopecia.
✕. Use of any experimental drug ≤28 days or 5 half-lives (whichever is shorter) prior to the first dose of CPO-100. For study drugs for which 5 half-lives is ≤28 days, a minimum of 14 days between termination of the study drug and administration of CPO-100 is required.
What they're measuring
1
Part A-1: Number of subjects with Dose Limiting Toxicities (DLTs)
Timeframe: At the end of cycle 1 (each cycle is 28 days)
2
Part A-2: Number of subjects with Dose Limiting Toxicities (DLTs) when prophylactic use of G-CSF is allowed during Cycle 1
Timeframe: At the end of cycle 1 (each cycle is 28 days)
3
Part B: Dose Expansion - Incidence and severity of Adverse Events
✕. Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89 and lutetium 177) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
✕. Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
✕. Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks previously and there is no evidence of central nervous system disease progression, and no requirement for chronic corticosteroid therapy.
✕. Leptomeningeal metastases or spinal cord compression due to disease.
✕. Known serious hypersensitivity reactions to docetaxel or life-threatening toxicity due to prior exposure to docetaxel