Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 26, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Circle Pharma
- Interventions being studied
- Drug: CID-078 Monotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
- 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.
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.
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.