A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO-100 in Adult Patients With Advanced Solid Tumors

Plain English Summary

Dose Escalation and Dose Expansion Study of CPO-100 in Patients With Advanced Solid Tumors is a Phase 1 clinical trial sponsored by Conjupro Biotherapeutics, Inc. studying Solid Tumor. This study tested CPO-100, a potential cancer treatment, in adults with advanced solid tumors. It was designed for patients who have not responded to or have no other standard treatment options. Participants received CPO-100 intravenously in cycles of 3 weekly doses with 1 week rest. This trial has been terminated and is no longer enrolling patients. The trial aims to enroll 34 participants.

Official 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

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced or metastatic solid tumors. Patients must have failed at least two prior lines of therapy or have no other standard treatment available. Specific criteria apply to prostate cancer patients regarding prior treatments and disease progression. Patients must have a good performance status (ECOG 0-2) and adequate organ function (bone marrow, liver, kidney). This trial is studying Solid Tumor, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures focused on identifying dose-limiting toxicities, which are the most severe side effects that occur at a specific dose, to determine a safe dosage for future studies. The specific primary outcome measures are: Part A-1: Number of subjects with Dose Limiting Toxicities (DLTs) (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 (At the end of cycle 1 (each cycle is 28 days)); Part B: Dose Expansion - Incidence and severity of Adverse Events (Screening to up to 4 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial aimed to find the right dose and assess the safety of CPO-100, a new drug, for patients with advanced cancers that have not responded to other treatments. This research targets Solid Tumor, where improved treatment options are needed.

Investor Insight

This was a Phase 1 study, meaning it was early-stage research focused on safety and dosage, making it difficult to assess market potential or approval probability at this stage. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if CPO-100 was being investigated for your specific type of cancer and if there were any available alternative treatments. Participation involved receiving the drug intravenously and undergoing regular monitoring for side effects and treatment response. The study required regular clinic visits for drug administration, blood tests, and imaging scans. The trial is being conducted at 8 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 34 participants

Interventions

• DRUG: CPO-100 — Docetaxel albumin-bound

Primary Outcomes

• Part A-1: Number of subjects with Dose Limiting Toxicities (DLTs) (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 (At the end of cycle 1 (each cycle is 28 days))
• Part B: Dose Expansion - Incidence and severity of Adverse Events (Screening to up to 4 years)

Secondary Outcomes

• 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)

Full Eligibility Criteria

Inclusion Criteria - Parts A-1, A-2, and B:

1. Presence of a pathologically documented (histology or cytology) locally advanced or metastatic solid tumor cancer.
2. 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).
3. Male or female patients18 years of age or older.
4. ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0, 1 or 2
5. 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.
6. Adequate major system function defined as:

   1. 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)
   2. 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.
   3. Renal function:

      Normal serum creatinine ≤1.5 mg/dL (133 μmol/L) OR calculated creatinine clearance ≥50 mL/min. (Cockcroft - Gault formula)
   4. Coagulation:

   Adequate coagulation parameters defined as International Normalization Ratio (INR) ≤2.
7. 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.
8. Life expectancy ≥3 months.
9. Willingness and ability to comply with study and follow-up procedures.
10. Ability to understand the nature of this study and give written informed consent.

Additional Inclusion Criteria for the dose expansion cohort - Part B

1. Pathologically confirmed (histology or cytology) of the following cancer types:

   1. Cohort 1: taxane naïve advanced/metastatic gastric cancer, lung cancer, head and neck cancer, or ovarian cancer;
   2. Cohort 2: taxane naïve advanced/metastatic breast cancer;
   3. Cohort 3: taxane naïve advanced/metastatic prostate cancer.
   4. Cohort 4: advanced/metastatic breast or ovarian cancer patients who have either progressed on a taxane or have developed progressive disease within 6 months of receiving a taxane;
2. With the exception of Cohort 4 above, taxane naïve patients must not have received taxane or taxane based therapies for their metastatic diseases. Patients who had suboptimal taxane exposure defined as having received less than 2 cycles of taxane or taxane based therapies due to intolerability for their metastatic diseases, patients who have received taxane or taxane based therapies for their neoadjuvant treatment or patients who have received taxane or taxane based therapies for their adjuvant treatment without disease progression during treatment are also considered taxane naïve, as long as they have not received taxane or taxane based therapies to treat the metastatic diseases.

Exclusion Criteria - Part A and B

1. Most recent chemotherapy ≤14 days or have residual NCI CTCAE greater than Grade 1 chemotherapy-related side effects, with the exception of alopecia.
2. 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.
3. 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.
4. Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
5. Previously untreated brai

Trial Locations

• University of California Los Angeles, Los Angeles, California, United States
• Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, United States
• Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
• Carolina BioOncology Institute, Huntersville, North Carolina, United States
• The Cleveland Clinic Foundation, Lyndhurst, Ohio, United States
• University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
• Virginia Cancer Specialist, Fairfax, Virginia, United States

Frequently Asked Questions

Related Conditions

• Solid Tumor
• Advanced Cancer
• Metastatic Cancer
• Prostate Cancer
• Gastric Cancer
• Lung Cancer
• Head and Neck Cancer
• Ovarian Cancer
• Breast Cancer
• Oncology

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