CID-078 for Cancer

Recruiting at 9 trial locations

Overseen By Lisa Kopp, DO, MPH

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Circle Pharma

Must not be taking: QT prolonging drugs

Disqualifiers: Brain metastases, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Variable (21-day cycles)

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called CID-078 for individuals with advanced solid tumors. It targets those whose tumors have not responded to other treatments and who lack standard treatment options. This trial suits patients with specific cancers, such as triple-negative breast cancer or small cell lung cancer, especially if previous treatments have failed. Participants should have measurable tumors and be able to swallow capsules. As a Phase 1 trial, this research focuses on understanding how CID-078 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had certain cancer treatments or surgeries within specific time frames before starting the trial.

Is there any evidence suggesting that CID-078 is likely to be safe for humans?

Research has shown that CID-078 has been safe and well-tolerated in early studies. In animal tests, the treatment proved effective, with 20% of the drug reaching the bloodstream when taken orally. This study marks the first time CID-078 is being tested in humans. The FDA has granted it Orphan Drug Designation, indicating potential benefits and manageable safety in early tests. This designation applies to promising drugs for rare conditions, suggesting some confidence in its safety and usefulness. However, as this is a phase 1 trial, the primary goal is to assess the treatment's safety and tolerability in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CID-078 for cancer because it offers a novel approach to treatment. Unlike traditional chemotherapy or targeted therapies, CID-078 may work by targeting specific cancer pathways more precisely, potentially leading to fewer side effects. Additionally, its new formulation might improve how the drug is absorbed in the body, offering enhanced effectiveness. This unique approach has the potential to address treatment-resistant cancers, making it a promising option in the fight against cancer.

What evidence suggests that CID-078 might be an effective treatment for cancer?

Research has shown that CID-078, a new type of drug, holds promise in fighting cancer. In lab studies, it effectively targeted tumors in various breast cancer models. The FDA has granted it "orphan drug" status for treating advanced small cell lung cancer, recognizing it as a potential treatment for rare conditions. Although human studies have provided limited information, these early results suggest that CID-078 could be effective against some advanced cancers. Participants in this trial will engage in different phases, including dose escalation, new formulation/pilot food effect, and dose expansion, to further evaluate CID-078's potential. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, including various cancers like breast and lung cancer. Participants should have a tumor that's progressed after treatment or has no satisfactory alternative treatment.

Inclusion Criteria

Life expectancy greater than 12 weeks

My breast cancer can be measured by specific medical criteria.

I can swallow pills.

Exclusion Criteria

I have side effects from cancer treatment that are not hair loss or skin color changes.

QTc interval (using Fridericia correction calculation) > 470 msec

I have a history of interstitial lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive CID-078 in 21-day treatment cycles during Dose Escalation and Dose Expansion phases

Variable (21-day cycles)

End of Treatment

End of Treatment visit conducted within 7 days of the last dose or decision to withdraw

Safety Follow-up

Participants are monitored for safety 28 days after the End of Treatment visit

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CID-078

Trial Overview The study is testing CID-078 Monotherapy, which targets proteins involved in cell division. It's an early-phase trial to see how safe it is and how well it works at different doses in people with advanced cancer.

How Is the Trial Designed?

Group I: Part 1a Dose Escalation, Part 1b New Formulation/Pilot Food Effect and Part 2 Dose Expansion Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Circle Pharma

Lead Sponsor

Trials

1

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06577987

NCT06577987 | Safety/Efficacy Study of CID-078 in ... 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 (Arginine-any ...

2. cancernetwork.com cancernetwork.com/view/cid-078-earns-fda-orphan-drug-designation-in-small-cell-lung-cancer

CID-078 Earns FDA Orphan Drug Designation in Small ... The FDA has granted CID-078, a cyclin A/B RxL inhibitor, orphan drug designation as a treatment for patients with advanced small cell lung cancer (SCLC).

3. circlepharma.com circlepharma.com/media/CID-078-241112%20Poster%20Final.pdf

CID-078, a first-in-class oral cyclin A/B-RxL inhibitor, elicits ... Evaluate the anti-tumor efficacy of CID-078 in 8 patient-derived xenografts. (PDX) models of breast cancer, including TNBC and ER+/HER2-subtypes. 2. Perform ...

4. onclive.com onclive.com/view/fda-grants-orphan-drug-designation-to-cid-078-for-sclc

FDA Grants Orphan Drug Designation to CID-078 for SCLC The phase 1 trial of CID-078 assesses safety, tolerability, pharmacokinetics, and preliminary antitumor activity in patients with advanced solid ...

5. ilcn.org ilcn.org/in-brief-july-23-2025/

In Brief: July 23, 2025 - ILCN.org (ILCN/WCLC) The US FDA grants Orphan Drug Designation to CID-078 for SCLC, and zidesamtinib demonstrates positive early data in ROS1-positive NSCLC.

6. circlepharma.com circlepharma.com/wp-content/uploads/2025/05/20250519-ASCO-2025-Poster-8.4-Clean-Version.pdf

A Phase 1 study to evaluate the safety, pharmacokinetics, ... In vivo models demonstrated a well-tolerated safety profile and 20% oral bioavailability. Figure 2. CID-078 activity across a panel of cancer cell lines.