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CID-078 for Advanced Solid Tumor Malignancies

This study is testing a new drug called CID-078 for people with advanced solid tumors, including metastatic (cancer that has spread) or refractory (cancer that hasn't responded to treatment) cancer. CID-078 is a Cyclin A/B-RxL inhibitor, which means it works by targeting specific proteins involved in cancer growth. The main goals of this study are to see how safe CID-078 is, what side effects it might cause, and how well it works. You might be able to join if you are 12 years or older and have an advanced solid tumor that has progressed or didn't respond to previous treatments. This study is currently evaluating the safety and effectiveness of CID-078.

Study design
This is an open-label, first-in-human study, meaning both you and your doctors will know you are receiving CID-078. It aims to enroll 220 participants across multiple centers.
What's involved
You would take CID-078 twice a day in repeating 21-day cycles until your disease progresses or you need to stop treatment.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for side effects for 28 days after your last dose of CID-078.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06577987

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

Active, Not Recruiting
PHASE1Ages 12+InterventionalTreatment
Circle Pharma
~220 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:CID-078 Monotherapy

At a glance

Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Incidence of Treatment Emergent Adverse Events (TEAEs) based on CTCAE v5.0.
Measured over From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.
+7 more outcomes measured

Conditions

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

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NCT06577987

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevadano site contact published

  • Dana Farber Cancer Institute

    Boston, Massachusettsno site contact published

  • Florida Cancer Specialists

    Sarasota, Floridano site contact published

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

  • NEXT Oncology

    San Antonio, Texasno site contact published

  • Oregon Health and Science University

    Portland, Oregonno site contact published

  • Sarah Cannon Research Institute

    Nashville, Tennesseeno site contact published

  • START Midwest

    Grand Rapids, Michiganno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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:

What this trial measures

  • Part 1: Incidence of Treatment Emergent Adverse Events (TEAEs) based on CTCAE v5.0.From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.
  • Part 1: Incidence of Treatment Related Adverse Events (TRAEs) based on CTCAE v5.0.From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.
  • Part 1: Incidence of Dose-Limiting Toxicities (DLTs).From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to end of cycle 1, up to 21 + 4 days.
  • Part 1: To determine recommended dose(s) for expansion (RDEs) for evaluation for Part 2.From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.

    The RDEs will be determined using all available information, including, but not limited to, AEs, dose-limiting toxicities, pharmacokinetic parameters, clinical laboratory tests, and efficacy measures observed in Part 1 Dose Escalation.

  • Part 2: Percentage of patients with confirmed objective response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors.From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.
  • Part 2: Duration of confirmed objective response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors.From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.
  • Part 2: Duration of disease progression free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors.From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.
  • Part 2: To determine Provisional Recommended Phase 2 Dose (RP2D) for future dose optimization.From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.

    Provisional RP2D will be determined using all available information, including, but not limited to, Adverse Events (AEs), dose-limiting toxicities, pharmacokinetic parameters, clinical laboratory tests, and efficacy measures observed during the study.