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Cyclin A/B-RxL inhibitor

CID-078 for Cancer

Phase 1

Recruiting

Research Sponsored by Circle Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Locally advanced or metastatic solid tumor malignancy that has progressed or was nonresponsive to available therapies and for which no standard or available curative therapy exists

Age ≥ 18 years

Must not have

Presence of unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation

Known or suspected brain metastases or spinal cord compression, unless asymptomatic and treated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Summary

This trial is testing a new drug called CID-078 in patients with advanced solid tumors to see if it is safe, well-tolerated, and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this is a first-in-human study of CID-078, specific side effects are not yet known but may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, and potential organ-related toxicities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread or not responded to treatment and there's no cure available.

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I am 18 years old or older.

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I am either surgically sterile, abstinent, or using two forms of birth control.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have brain or spinal metastases but am symptom-free after treatment.

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I have a history of interstitial lung disease.

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I have severe heart failure or serious heart rhythm problems needing treatment.

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I have not had another cancer within the last 2 years, except for one that was treated properly.

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I have had a solid organ transplant.

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I do not have any severe illnesses that could interfere with the study.

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I am taking medication that affects my heart's rhythm or have risk factors for a specific heart rhythm condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: To determine recommended dose(s) for expansion (RDEs) for evaluation for Part 2.

Part 2: To determine Provisional Recommended Phase 2 Dose (RP2D) for future dose optimization.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Part 1 Dose Escalation and Part 2 Dose ExpansionExperimental Treatment1 Intervention

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Circle PharmaLead Sponsor

~67 spots leftby Jan 2027

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