RECRUITING

Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies

Conditions

Advanced Solid Tumor Metastatic Solid Tumor Refractory Solid Tumor Cancer Lung Cancer Triple Negative Breast Cancer Breast Neoplasms Neuroendocrine Tumors Neuroendocrine Carcinoma Phase 1 CID-078 Estrogen

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first-in-human, multicenter, open-label, phase 1 study to evaluate safety, tolerability, and efficacy of CID-078, a Cyclin A/B-RxL inhibitor, in patients with advanced solid tumors.

Official Title

A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Cyclin A/B-RxL Inhibitor CID-078 in Patients With Advanced Solid Tumor Malignancies

Quick Facts

Study Start:2024-08-14

Study Completion:2027-03-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06577987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Locally advanced or metastatic solid tumor malignancy that has progressed or was nonresponsive to available therapies and for which no standard or available curative therapy exists. 2. Patients with Small Cell Lung Cancer (SCLC) and Non-small Cell Lung Cancer (NSCLC) must have measurable disease per RECIST v1.1. All other patients that do not have SCLC or NSCLC must have evaluable, but do not have to have measurable disease. 3. Age ≥ 18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5. Life expectancy greater than 12 weeks. 6. Ability to swallow capsules by mouth. 7. Have the following laboratory values: 1. Calculated creatinine clearance (CrCl) ≥ 60 mL/min/1.73 m\^2 (by Cockroft-Gault formula); actual body weight must be used for CrCl unless Body Mass Index (BMI) \> 30 kg/m\^2 then lean body weight must be used. 2. Total bilirubin ≤ 1.5 × ULN unless prior history of Gilbert's syndrome with Sponsor Medical Monitor approval 3. Aspartate transaminase and alanine transaminase ≤ 2.5 × upper limit normal (ULN), or ≤ 5 × ULN if due to liver involvement by tumor 4. Hemoglobin ≥ 9.0 g/dL (last transfusion \> 14 days prior to Cycle 0 Day 1/ Cycle 1 Day 1) 5. Platelets ≥ 100 × 10\^9 cells/L (last platelet transfusion \> 14 days prior to C0D1/C1D1) 6. Absolute neutrophil count ≥ 1.2 ×10\^9 cells/L (last dose of hematopoietic growth factors \>14 days from Cycle 0 Day 1/ Cycle 1 Day 1) 8. Male and female patients must be surgically sterile or commit to sexual abstinence or use 2 acceptable forms of birth control methods. 9. Women of child-bearing potential must have a negative serum pregnancy test during Screening and a negative urine or serum test prior to Cycle 0 Day 1/ Cycle 1 Day 1.	1. Treatment with any of the following: 1. Targeted therapy ≤ 8 days or 5× the terminal phase elimination half-lives, whichever is shorter, prior to Cycle 0 Day 1/ Cycle 1 Day 1. 2. Systemic anticancer treatment (excluding targeted therapy as described above) ≤ 14 days prior to Cycle 0 Day 1/ Cycle 1 Day 1. 3. Radiotherapy ≤ 28 days and palliative radiation ≤ 14 days prior to Cycle 0 Day 1/ Cycle 1 Day 1. 4. Immunotherapy ≤ 28 days prior to Cycle 0 Day 1/ Cycle 1 Day 1. 5. Major surgery ≤ 28 days prior to Cycle 0 Day 1/ Cycle 1 Day 1. 2. Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor Medical Monitor. 3. Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic and treated. 4. Past medical history of interstitial lung disease, or any evidence of clinically active interstitial lung disease. 5. Patient has a history of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment. 6. QTc interval (using Fridericia correction calculation) \> 470 msec. 7. Current treatment with medication known to prolong the QT/QTc (corrected QT) interval or history of additional risk factors for Torsade de Pointes. 8. Pregnant or lactating women. 9. History of another primary malignancy ≤ 2 years prior to Cycle 0 Day 1/ Cycle 1 Day 1, except for adequately treated cancer. 10. Malabsorption syndrome or other conditions that may interfere with adequate absorption of investigational product. 11. Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including untreated HIV and active clinical tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 12. Current endocrinopathies, unless in the opinion of the investigator endocrine complications are stable and well controlled and study participation does not jeopardize patient's risk. 13. Prior solid organ transplantation

Inclusion Criteria

Exclusion Criteria

1. Locally advanced or metastatic solid tumor malignancy that has progressed or was nonresponsive to available therapies and for which no standard or available curative therapy exists.
2. Patients with Small Cell Lung Cancer (SCLC) and Non-small Cell Lung Cancer (NSCLC) must have measurable disease per RECIST v1.1. All other patients that do not have SCLC or NSCLC must have evaluable, but do not have to have measurable disease.
3. Age ≥ 18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
5. Life expectancy greater than 12 weeks.
6. Ability to swallow capsules by mouth.
7. Have the following laboratory values:
1. Calculated creatinine clearance (CrCl) ≥ 60 mL/min/1.73 m\^2 (by Cockroft-Gault formula); actual body weight must be used for CrCl unless Body Mass Index (BMI) \> 30 kg/m\^2 then lean body weight must be used.
2. Total bilirubin ≤ 1.5 × ULN unless prior history of Gilbert's syndrome with Sponsor Medical Monitor approval
3. Aspartate transaminase and alanine transaminase ≤ 2.5 × upper limit normal (ULN), or ≤ 5 × ULN if due to liver involvement by tumor
4. Hemoglobin ≥ 9.0 g/dL (last transfusion \> 14 days prior to Cycle 0 Day 1/ Cycle 1 Day 1)
5. Platelets ≥ 100 × 10\^9 cells/L (last platelet transfusion \> 14 days prior to C0D1/C1D1)
6. Absolute neutrophil count ≥ 1.2 ×10\^9 cells/L (last dose of hematopoietic growth factors \>14 days from Cycle 0 Day 1/ Cycle 1 Day 1)
8. Male and female patients must be surgically sterile or commit to sexual abstinence or use 2 acceptable forms of birth control methods.
9. Women of child-bearing potential must have a negative serum pregnancy test during Screening and a negative urine or serum test prior to Cycle 0 Day 1/ Cycle 1 Day 1.

1. Treatment with any of the following:
1. Targeted therapy ≤ 8 days or 5× the terminal phase elimination half-lives, whichever is shorter, prior to Cycle 0 Day 1/ Cycle 1 Day 1.
2. Systemic anticancer treatment (excluding targeted therapy as described above) ≤ 14 days prior to Cycle 0 Day 1/ Cycle 1 Day 1.
3. Radiotherapy ≤ 28 days and palliative radiation ≤ 14 days prior to Cycle 0 Day 1/ Cycle 1 Day 1.
4. Immunotherapy ≤ 28 days prior to Cycle 0 Day 1/ Cycle 1 Day 1.
5. Major surgery ≤ 28 days prior to Cycle 0 Day 1/ Cycle 1 Day 1.
2. Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor Medical Monitor.
3. Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic and treated.
4. Past medical history of interstitial lung disease, or any evidence of clinically active interstitial lung disease.
5. Patient has a history of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
6. QTc interval (using Fridericia correction calculation) \> 470 msec.
7. Current treatment with medication known to prolong the QT/QTc (corrected QT) interval or history of additional risk factors for Torsade de Pointes.
8. Pregnant or lactating women.
9. History of another primary malignancy ≤ 2 years prior to Cycle 0 Day 1/ Cycle 1 Day 1, except for adequately treated cancer.
10. Malabsorption syndrome or other conditions that may interfere with adequate absorption of investigational product.
11. Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including untreated HIV and active clinical tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
12. Current endocrinopathies, unless in the opinion of the investigator endocrine complications are stable and well controlled and study participation does not jeopardize patient's risk.
13. Prior solid organ transplantation

Contacts and Locations

Study Contact

Lisa Kopp, DO, MPH

CONTACT

1-877-648-8777

CID078ClinicalTrials@circlepharma.com

Study Locations (Sites)

START Midwest

Grand Rapids, Michigan, 49546

United States

UH Seidman Cancer Center

Cleveland, Ohio, 44106

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

NEXT Oncology

San Antonio, Texas, 78229

United States

START Mountain

West Valley City, Utah, 84119

United States

Collaborators and Investigators

Sponsor: Circle Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-14

Study Completion Date2027-03-14

Study Record Updates

Study Start Date2024-08-14

Study Completion Date2027-03-14

Terms related to this study

Keywords Provided by Researchers

Phase 1
CID-078
Estrogen

Additional Relevant MeSH Terms

Advanced Solid Tumor
Metastatic Solid Tumor
Refractory Solid Tumor
Cancer
Lung Cancer
Triple Negative Breast Cancer
Breast Neoplasms
Neuroendocrine Tumors
Neuroendocrine Carcinoma