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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, Metastatic Solid Tumor, Refractory Solid Tumor, Cancer, Lung Cancer, Triple Negative Breast Cancer, Breast Neoplasms, Neuroendocrine Tumors, Neuroendocrine Carcinoma, RB1 Gene Mutation

In brief

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.

Key facts

Study ID

NCT06577987

Run by

Circle Pharma

People needed

220

Starts

2024-08-14

Expected to finish

2027-03-14

Last updated by the study team

2025-09-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient must meet all of the following inclusion criteria to be eligible to participate in this study.
• Advanced or metastatic solid tumor malignancy that has progressed or was non responsive to available therapies and for which no standard or available curative therapy exists.
• Triple negative breast cancer (TNBC) cohort: histologically or cytologically confirmed TNBC per American Society for Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria, based on the most recent analyzed biopsy or other pathology specimen.
• Small cell lung cancer (SCLC) cohort: histologically or cytologically confirmed relapsed/refractory SCLC.
• Retinoblastoma 1 (RB1)-altered solid tumor cohort: solid tumors harboring a documented RB1 genomic alteration or Rb protein LoF, as identified through assays performed at Clinical Laboratory Improvement Amendments (CLIA)-certified or other similarly certified laboratories.
• Patients must have measurable disease by RECIST v1.1.
• Age ≥ 12 years and at least 40 kg in body weight.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (patients ≥ 18 years of age), Karnofsky performance status ≥ 70% (patients ≥ 16 to < 18 years of age), or Lansky performance status ≥ 70% (patients < 16 years of age). Patients who are unable to walk because of paralysis, but who can sit in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score (Appendix 1).
• Life expectancy >12 weeks.
• For patients ≥ 18 years of age: able to undergo a fresh biopsy if medically feasible.
• Ability to swallow capsules by mouth.
• Have the following laboratory values:
• For patients ≥ 18 years of age: calculated CrCl ≥ 60 mL/min/1.73 m2 by Cockroft-Gault formula (actual body weight must be used for CrCl unless BMI > 30 kg/m2 then lean or ideal body weight must be used based on institutional practice), or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 based alternative methods of determination (e.g., modification of diet in renal disease [MDRD], 24-hour urine collection) if consistent with local or institutional practice. For patients < 18 years of age: serum creatinine within normal limits (as defined below) or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 based on local institutional practice for determination.
• Age at Screening Maximum Serum Creatinine SI Unit age 12 to < 15 years - 0.81 mg/dL; age 15 to < 18 years (male) - 1.08 mg/dL; age 15 to < 18 years (female) - 0.84 mg/dL
• Total bilirubin ≤ 1.5 × ULN unless prior history of Gilbert's syndrome with Sponsor Medical Monitor approval.
• Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN, or ≤ 5 × ULN if due to liver involvement by tumor.
• Hemoglobin ≥ 9.0 g/dL (last transfusion > 14 days prior to first dose of study drug).
• Platelets ≥ 100 × 10\^9 cells/L (last platelet transfusion > 14 days prior to first dose of study drug).
• Absolute neutrophil count ≥ 1.2 ×10\^9 cells/L (last dose of hematopoietic growth factors > 14 days from first dose of study drug).
• Females of childbearing potential must commit to sexual abstinence or to use two acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) for the duration of the study and for four months following the last dose of study treatment. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential. Male patients must be sterile (biologically or surgically), commit to sexual abstinence or to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for four months following the last dose of study treatment.
• Females of childbearing potential must have a negative serum pregnancy test during Screening and a negative urine or serum test prior to receiving first dose of study drug. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential.
• Signed and dated IRB/EC-approved ICF for potential patients ≥ 18 years of age. A signed and dated IRB/EC-approved adolescent assent form may also be required for patients 12 to 17 years of age in addition to an ICF signed by a parent or legal guardian.
• Exclusion Criteria:
• A patient who meets any of the following exclusion criteria will be ineligible to participate in this study.
• Treatment with any of the following:

You may not qualify if…

• A patient who meets any of the following exclusion criteria will be ineligible to participate in this study:
• Treatment with any of the following:
• Targeted therapy ≤ eight days or 5× the terminal phase elimination half-lives, whichever is shorter, prior to the first dose of study drug.
• Systemic anticancer treatment (excluding targeted therapy as described above) ≤ 14 days prior to first dose of study drug.
• Radiotherapy ≤ 28 days and palliative radiation ≤ 14 days prior to the first dose of study drug. If irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions.
• Immunotherapy ≤ 28 days prior to the first dose of study drug.
• Major surgery ≤ 28 days prior to the first dose of study drug.
• 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.
• Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, treated with surgery and/or radiation, and has been stable without requiring escalating doses of corticosteroids or anti-convulsant medications for at least four weeks prior for the first dose of study drug.
• Prior therapy with CID-078.
• Known hypersensitivity to CID-078 or any drugs similar in structure or class.
• Past medical history of interstitial lung disease, or any evidence of clinically active interstitial lung disease. Patients with sub-clinical pneumonitis who have received anti-cancer therapy (e.g., immunotherapy, ADC) previously can be included if their condition is stable without any medical intervention.
• 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.
• Heart rate corrected QT (QTc) interval (using Fridericia correction calculation) > 470 msec.
• Current treatment with medication known to prolong the QT/QTc interval (see examples from Table 28) or history of additional risk factors for Torsade de Pointes (e.g., heart failure, Grade ≥ 3 hypokalemia, family history of long QT syndrome). Patient who has adequately controlled condition or requires use of medications from Table 28 may be allowed upon agreement by the Investigator and Sponsor Medical Monitor.
• Pregnant or lactating women.
• History of another primary malignancy ≤ two years prior to starting study drug, except for adequately treated cancer (e.g., basal, or squamous cell carcinoma of the skin or cancer of the cervix in situ).
• Malabsorption syndrome or other conditions (e.g., refractory nausea and vomiting, external biliary diversion, or any significant small bowel resection) that may interfere with adequate absorption of investigational product.
• Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including untreated human immunodeficiency virus [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.
• Current endocrinopathies, unless in the opinion of the Investigator, endocrine complications are stable and well controlled and study participation does not jeopardize patient's health and wellbeing. Patients with asymptomatic endocrine disease on endocrine replacement therapy are eligible.
• Active hepatitis B infection as defined by a positive hepatitis B surface antigen (HbsAg) test and detectable hepatitis B virus (HBV) DNA. Patients ineligible due to detectable levels of HBV DNA at baseline may be rescreened for enrollment if their HBV DNA levels become undetectable after treatment with antiviral agents, and upon agreement between the Investigator and Sponsor Medical Monitor.
• Active hepatitis C infection as defined by a reactive hepatitis C virus (HCV) antibody test and detectable HCV RNA.
• For patients with a history of HIV or acquired immunodeficiency syndrome (AIDS):
• Must have a CD4+ T-cell count ≥ 350 cells/μL
• Have not had an opportunistic infection within the previous 12 months.

Where it is running

• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States (enrolling)
• UH Seidman Cancer Center — Cleveland, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• START Mountain — West Valley City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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