Active Not RecruitingPhase 1NCT06577987
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCID-078 Monotherapy

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 26, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Circle Pharma

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Circle Pharma
Interventions being studied
Drug: CID-078 Monotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Part 1a/1b A patient must meet all of the following inclusion criteria to be eligible to participate in this study. 1. 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 for which no standard or available curative therapy exists.
  • 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 as data become available. Patient must have progressed or was non-responsive to available therapies and for which no standard or available curative therapy exists 2. Measurable disease per RECIST v1.1. 3. Age ≥ 18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5. Life expectancy \> 12 weeks. 6. Able to undergo a fresh biopsy if medically feasible. 7. Ability to swallow capsules by mouth. 8. 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 \[BMI\] is \> 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. 2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) unless prior history of Gilbert's syndrome with Sponsor Medical Monitor approval. 3. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN, or ≤ 5 × ULN if due to liver involvement by tumor. 4. Hemoglobin ≥ 9.0 g/dL (last transfusion \> 14 days prior to first dose of study drug). 5. Platelets ≥ 100 × 10\^9 cells/L (last platelet transfusion \> 14 days prior to first dose of study drug). 6. Absolute neutrophil count ≥ 1.2 × 10\^9 cells/L (last dose of hematopoietic growth factors \> 14 days from first dose of study drug). 9. 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 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. 10. 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 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. 11. 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 Inclusion Criteria Patients who consent to participate in the pilot food effect cohort will also be required to meet the following inclusion criteria: 12. Able to eat a standardized high-fat, high-caloric or low-fat meal (as applicable to the food effect cohort assigned) within 25 minutes.
Reasons someone may not be able to joinExclusion criteria

A patient who meets any of the following

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Florida Cancer SpecialistsSarasota, Florida
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • START MidwestGrand Rapids, Michigan
  • Comprehensive Cancer Centers of NevadaLas Vegas, Nevada
  • UH Seidman Cancer CenterCleveland, Ohio
  • Oregon Health and Science UniversityPortland, Oregon
  • Sarah Cannon Research InstituteNashville, Tennessee
  • MD Anderson Cancer CenterHouston, Texas
  • NEXT OncologySan Antonio, Texas
  • START MountainWest Valley City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 26, 2026. Always confirm current availability with the study team.

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