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

NCT06577987 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CID-AB1-24001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 10

Brief 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.

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

Keywords

Phase 1; CID-078; Estrogen

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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: 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.

  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.

  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.

Secondary Outcomes (9)

• Part 1: 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 1: 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 1: 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 1: Maximum plasma concentration (Cmax) of CID-078 in fasted and fed state.

  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: Time to maximum plasma concentration (Tmax) of CID-078 in fasted and fed state.

  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.

Study Arms (1)

Part 1a Dose Escalation, Part 1b New Formulation/Pilot Food Effect and Part 2 Dose Expansion

EXPERIMENTAL

Drug: CID-078 Monotherapy

Interventions

CID-078 Monotherapy DRUG

Cyclin A/B-RxL inhibitor, twice-a-day in repeating 21-day treatment cycles until disease progression or discontinuation criteria.

Part 1a Dose Escalation, Part 1b New Formulation/Pilot Food Effect and Part 2 Dose Expansion

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 (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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Circle Pharma: lead

Study Sites (10)

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

RECRUITING

UH Seidman Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

START Mountain

West Valley City, Utah, 84119, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Lung Neoplasms; Triple Negative Breast Neoplasms; Breast Neoplasms; Neuroendocrine Tumors; Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Central Study Contacts

Lisa Kopp, DO, MPH

CONTACT

1-877-648-8777; CID078ClinicalTrials@circlepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 29, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): March 14, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-05

Locations

US (10)