Dose Escalation and Dose Expansion Study of CPO-100 in Patients With Advanced Solid Tumors

NCT04931823 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CPO-100-US-101
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Solid Tumor

Keywords

Breast Cancer; Prostate Cancer; Gastric Cancer; Lung Cancer; Head and Neck Cancer; Ovarian Cancer; Docetaxel; Docetaxel albumin-bound; DTX-HSA; CPO-100; Phase 1; Taxane Naïve; Solid Tumor; Stage 4; Metastatic Cancer; Cancer; Advanced Cancer; Taxane; Non-resectable tumor

Outcome Measures

Primary Outcomes (3)

• Part A-1: Number of subjects with Dose Limiting Toxicities (DLTs)

  Incidence of dose-limiting toxicities (DLT) during the DLT evaluation period. DLTs assessed per CTCAE v5.0, include grade ≥ 4 neutropenia, thrombocytopenia, anemia; grade ≥ 3 febrile neutropenia, nausea, vomiting, diarrhea, skin rash, fatigue, infusion reaction; any other grade ≥ 2 non-hematologic toxicity judged to be dose limiting; and treatment delay \>14 days due to unresolved toxicities.

  At the end of cycle 1 (each cycle is 28 days)

• Part A-2: Number of subjects with Dose Limiting Toxicities (DLTs) when prophylactic use of G-CSF is allowed during Cycle 1

  Incidence of dose-limiting toxicities (DLT) during the DLT evaluation period. DLTs assessed per CTCAE v5.0, include grade ≥ 4 neutropenia, thrombocytopenia, anemia; grade ≥ 3 febrile neutropenia, nausea, vomiting, diarrhea, skin rash, fatigue, infusion reaction; any other grade ≥ 2 non-hematologic toxicity judged to be dose limiting; and treatment delay \>14 days due to unresolved toxicities.

  At the end of cycle 1 (each cycle is 28 days)

• Part B: Dose Expansion - Incidence and severity of Adverse Events

  Incidence and severity of Adverse Events per CTCAE v5.0, including changes of Clinical Laboratory Values, Physical Exams, Vital Signs, Weight, Eastern Cooperative Oncology Group (ECOG) and ECG from baseline. Dosing delays and dosing intensity.

  Screening to up to 4 years

Secondary Outcomes (8)

• Area Under the Curve (AUC0-t) for CPO-100

  0, .5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours (Day1) and Day 15

• Area Under the Curve (AUC0-∞) for CPO-100

  0, .5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours (Day1)

• Cmax for CPO-100

  0, .5, 1, 2, 3, 4 6, 8, 24, 48 and 72 hours (Day 1) and Day 15

• Tmax for CPO-100

  Time Frame: 0, .5, 1, 2, 3, 4 6, 8, 24, 48 and 72 hours (Day 1) and Day 15

• Overall response rate (ORR)

  At the end of every 28 day cycle for up to 4 years

Study Arms (6)

Part A-1: Dose Escalation

EXPERIMENTAL

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks).

Drug: CPO-100

Part A-2: Dose escalation

EXPERIMENTAL

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) with the option to administer G-CSF in cycle one. Starting dose will be 45 mg/m2.

Drug: CPO-100

Part B: Cohort 1

EXPERIMENTAL

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) at the recommended Phase 2 dose (X mg/m2) in 15 patients with taxane naïve advanced solid tumors of gastric, head and neck, lung, and ovarian.

Drug: CPO-100

Part B: Cohort 2

EXPERIMENTAL

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) at the recommended Phase 2 dose (X mg/m2) in 15 patients with taxane naïve advanced breast cancer.

Drug: CPO-100

Part B: Cohort 3

EXPERIMENTAL

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) at the recommended Phase 2 dose (X mg/m2) in 15 patients with taxane naïve advanced prostate cancer.

Drug: CPO-100

Part B: Cohort 4

EXPERIMENTAL

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) at the recommended Phase 2 dose (X mg/m2) in 15 patients with either ovarian or/and breast cancer who have failed prior taxane treatment (ie, either progressed on a taxane regimen or within 6 months of receiving a taxane regimen).

Drug: CPO-100

Interventions

CPO-100 DRUG

Docetaxel albumin-bound

Also known as: DTX-HSA

Part A-1: Dose Escalation; Part A-2: Dose escalation; Part B: Cohort 1; Part B: Cohort 2; Part B: Cohort 3; Part B: Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count (ANC) ≥1.5 x109/L Platelet count ≥ 100 x109/L Hemoglobin ≥9 g/dL without transfusion (the patient needs to be transfusion independent)
• Hepatic function:
• Total bilirubin ≤ upper limit of normal (ULN) (unless the subject has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of total bilirubin); And aspartate aminotransferase (AST) / serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT) / serum glutamic pyruvic transaminase (SGPT) ≤ 1.5 x ULN with alkaline phosphatase ≤2.5 x ULN.
• Renal function:
• Normal serum creatinine ≤1.5 mg/dL (133 μmol/L) OR calculated creatinine clearance ≥50 mL/min. (Cockcroft - Gault formula)
• Coagulation:
• Adequate coagulation parameters defined as International Normalization Ratio (INR) ≤2.
• Adequate methods of contraception for female patients of reproductive potential during the study and for at least 6 months following last dose. Male patients with female partners of childbearing potential and women patients of childbearing potential are required to use two forms of acceptable contraception, including 1 barrier method, during their participation in the study and for at least 3 months following last dose. Male patients must also refrain from donating sperm during their participation in the study.

You may not qualify if:

• 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.
• 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
• Pregnant or lactating.
• Acute or chronic liver, renal, or pancreatic disease that in the opinion of the investigator would put the patient at unjustified increased risk by participating in this study or could interfere with the interpretation of the study results.
• Other systemic disease that in the opinion of the investigator would put the patient at unjustified increased risk by participating in this study or could interfere with the interpretation of the study results.
• Any of the following cardiac diseases currently or within the last 6 months:
• Left ventricular ejection fraction (LVEF) \<50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
• Corrected QT (QTc) interval \>470 ms (average of 3 tracings) on screening electrocardiogram (ECG)
• Unstable angina pectoris
• Congestive heart failure according to the New York Heart Association (NYHA) ≥ Grade 2)

Sponsors & Collaborators

• Conjupro Biotherapeutics, Inc.: lead
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: collaborator

Study Sites (8)

University of California Los Angeles

Los Angeles, California, 75246, United States

Location

Yale University School of Medicine - Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

The Cleveland Clinic Foundation

Lyndhurst, Ohio, 44124, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Virginia Cancer Specialist

Fairfax, Virginia, 22031, United States

Location

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Related Links

• Phase II study of weekly docetaxel in patients with metastatic breast cancer
• Metronomics: towards personalized chemotherapy?
• Dexamethasone differentially depletes tumour and peripheral blood lymphocytes and can impact the efficacy of chemotherapy/checkpoint blockade combination treatment
• Alpha-1-acid glycoprotein as an independent predictor for treatment effects and a prognostic factor of survival in patients with non-small cell lung cancer treated with docetaxel
• Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer
• Taxanes for the treatment of metastatic breast cancer
• Emerging treatment using tubulin inhibitors in advanced non-small cell lung cancer
• Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer
• Pharmacokinetics and pharmacodynamics of protein-unbound docetaxel in cancer patients
• Elevated alpha1-acid glycoprotein in gastric cancer patients inhibits the anticancer effects of paclitaxel, effects restored by co-administration of erythromycin
• Weekly docetaxel in the treatment of metastatic breast cancer
• A dose finding study of weekly and every-3-week nab-Paclitaxel followed by carboplatin as first-line therapy in patients with advanced non-small cell lung cancer
• Docetaxel serum protein binding with high affinity to alpha 1-acid glycoprotein
• A phase I study of liposomal-encapsulated docetaxel (LE-DT) in patients with advanced solid tumor malignancies
• Annual Report to the Nation on the status of cancer, 1975-2008, featuring cancers associated with excess weight and lack of sufficient physical activity
• Cancers with increasing incidence trends in the United States: 1999 through 2008
• Future of cancer incidence in the United States: burdens upon an aging, changing nation
• U.S. pancreatic cancer rates
• Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer
• Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial
• Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine
• Modest improvement in overall survival for patients with metastatic pancreatic cancer: a trend analysis using the surveillance, epidemiology, and end results registry from 1988 to 2008

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Stomach Neoplasms; Lung Neoplasms; Head and Neck Neoplasms; Ovarian Neoplasms; Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Officials

  Conjupro Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Modified "3+3" dose escalation design followed by dose expansion at the MTD (maximum tolerated dose).

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 18, 2021
• Study Start: March 24, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)