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Tests treatment safety and results for Advanced Solid Tumor
Official title Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT06577987
What this study is testing
What is CID-078 Monotherapy?
CID-078 Monotherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Part 1a/1b A patient must meet all of the following to be eligible to participate in this study.
- Solid tumor malignancy meeting the following criteria:
- Part 1a Dose Escalation and Part 1b New Formulation Dose Escalation/Pilot Food Effect Cohort: locally advanced or metastatic solid tumor malignancy...
- Part 1a and Part 1b Backfill: patients with TNBC, SCLC, and solid tumors harboring a RB1 or CDKN2A/B loss genomic alteration or Rb protein LoF...
- Measurable disease per RECIST v1.1.
You likely can't join 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...
- Immunotherapy ≤ 28 days prior to the first dose of study drug.
See the full eligibility criteria
Who can join
- Part 1a/1b A patient must meet all of the following to be eligible to participate in this study.
- Solid tumor malignancy meeting the following criteria:
- Part 1a Dose Escalation and Part 1b New Formulation Dose Escalation/Pilot Food Effect Cohort: locally advanced or metastatic solid tumor malignancy that has progressed or was non responsive to available therapies and...
- Part 1a and Part 1b Backfill: patients with TNBC, SCLC, and solid tumors harboring a RB1 or CDKN2A/B loss genomic alteration or Rb protein LoF. Additional tumor types or genomic alterations may be considered by the SRC...
- Measurable disease per RECIST v1.1.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy \> 12 weeks.
- Able to undergo a fresh biopsy if medically feasible.
- Ability to swallow capsules by mouth.
- Have the following laboratory values:
- 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] is \> 30 kg/m2, then lean or ideal body weight must be used...
- Total bilirubin ≤ 1.5 × upper limit of normal (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, or any form of...
- Females of childbearing potential must have a negative serum pregnancy test during Screening and a negative urine or serum pregnancy test prior to receiving the first dose of study drug. Females who are at least two...
- Signed and dated Institutional Review Board (IRB)/Ethics Committee (EC)-approved ICF before any protocol-directed screening procedures are performed. Part 1b Pilot Food Effect Cohort - Specific Patients who consent to...
- Able to eat a standardized high-fat, high-caloric or low-fat meal (as applicable to the food effect cohort assigned) within 25 minutes.
What rules you out
- 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...
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- To be on current antiretroviral therapy (ART) regimen for a minimum of four weeks and have an HIV viral load \< 400 copies/mL at the time of enrollment.
- Patients who are using concurrent strong cytochrome P450 (CYP)3A4 inhibitors (e.g., ritonavir, cobicistat) or strong CYP3A4 inducers are excluded from the study if their regimen cannot be altered. Otherwise, eligible...
- Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 14 days or five terminal half-lives prior to the first dose of study drug, whichever is shorter.
- Active bleeding disorders.
- Prior solid organ transplantation.
- Is, in the Investigator's opinion, unable or unwilling to comply with the study procedures.
- Have any condition or illness that, in the opinion of the Investigator, might compromise patient safety or interfere with the evaluation of the safety of the study drug. Study Population (Part 2 Dose Expansion)...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 the 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...
- 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...
- 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...
- 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)...
- Patient has a history of CHF Class III/IV according to the NYHA Functional Classification Appendix 2) or serious cardiac arrhythmias requiring treatment.
- QTc interval (using Fridericia correction calculation) (QTcF) \> 470 msec.
- Current treatment with medication known to prolong the QT/QTcF interval or history of additional risk factors for Torsade de Pointes (e.g., heart failure, Grade ≥ 3 hypokalemia, family history of long QT syndrome)...
- 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...
- 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...
- 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...
- Active hepatitis B infection as defined by a positive HBsAg test and detectable HBV DNA. Patients ineligible due to detectable levels of HBV DNA at baseline may be rescreened for enrollment if their HBV DNA levels...
- Active hepatitis C infection as defined by a reactive HCV antibody test and detectable HCV RNA.
- For patients with a history of HIV or AIDS:
- Must have a CD4+ T-cell count ≥ 350 cells/μL.
- Have not had an opportunistic infection within the previous 12 months.
- To be on current ART regimen for a minimum of four weeks and have an HIV viral load \< 400 copies/mL at the time of enrollment.
- Patients who are using concurrent strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat) or strong CYP3A4 inducers are excluded from the study if their regimen cannot be altered. Otherwise, eligible study patients could...
- Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate as specifically listed in Table 26 and Table 27 within 14 days or five terminal half-lives prior to the first...
- Active bleeding disorders.
- Prior solid organ transplantation.
- Is, in the Investigator's opinion, unable or unwilling to comply with the study procedures.
- Have any condition or illness that, in the opinion of the Investigator, might compromise patient safety or interfere with the evaluation of the safety of the study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Las Vegas, Nevada, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; Las Vegas, Nevada, United States; Cleveland, Ohio, United States; Portland, Oregon, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.