Actively Recruiting
Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
Led by Circle Pharma · Updated on 2025-09-15
220
Participants Needed
10
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Locally advanced or metastatic solid tumor malignancy progressed or non-responsive to available therapies with no standard curative treatment
- For dose expansion, patients with triple negative breast cancer, small cell lung cancer, or solid tumors with RB1 or CDKN2A/B loss alterations
- Measurable disease by RECIST v1.1
- Age 18 years or older for Part 1a/1b; age 12 years or older and at least 40 kg for Part 2
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or equivalent for younger patients
- Life expectancy greater than 12 weeks
- Able to undergo a fresh biopsy if medically feasible (for patients 18 years or older)
- Ability to swallow capsules
- Adequate laboratory values including kidney function, liver enzymes, hemoglobin, platelets, and neutrophils
- Females of childbearing potential must use two forms of birth control or commit to sexual abstinence during the study and for four months after
- Negative pregnancy test for females of childbearing potential prior to first dose
- Signed informed consent form before any study procedures
You will not qualify if you...
- Treatment with targeted therapy within 8 days or 5 times the drug half-life before study drug
- Systemic anticancer treatment within 14 days before study drug
- Radiotherapy within 28 days or palliative radiation within 14 days before study drug
- Immunotherapy within 28 days before study drug
- Major surgery within 28 days before study drug
- Unresolved Grade 2 or higher toxicity from prior cancer treatment except alopecia and skin pigmentation
- Known or suspected brain metastases or spinal cord compression unless stable and treated
- Prior therapy with CID-078
- Known allergy to CID-078 or similar drugs
- History or active interstitial lung disease except stable sub-clinical pneumonitis
- History of severe heart failure or serious arrhythmias requiring treatment
- QTc interval greater than 470 milliseconds
- Current treatment with medications that prolong QT interval unless controlled
- Pregnant or lactating women
- History of another primary cancer within 2 years except treated skin or cervical cancer in situ
- Malabsorption syndrome or conditions affecting drug absorption
- Uncontrolled illnesses including active infections, cardiac or liver disease, or psychiatric conditions limiting compliance
- Unstable or uncontrolled endocrine disorders
- Active hepatitis B or C infection
- HIV patients must have stable disease, controlled viral load, and meet treatment criteria
- Current treatment with strong CYP3A4 inhibitors or inducers within 14 days prior to study drug
- Active bleeding disorders
- Prior solid organ transplant
- Unable or unwilling to comply with study procedures
- Any condition that may compromise safety or interfere with study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
4
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
Actively Recruiting
5
UH Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
6
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
10
START Mountain
West Valley City, Utah, United States, 84119
Actively Recruiting
Research Team
L
Lisa Kopp, DO, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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