CCI-001 for Cancer

Overseen By Charles Allard

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: PharmaMatrix Holdings Ltd

Must not be taking: Corticosteroids, Anticonvulsants, Warfarin

Disqualifiers: CNS metastases, Cardiac fibrosis, HIV, others

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

Compensation: Varies

Number of Visits: 10

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, CCI-001, which targets a protein needed for cell division. It aims to find the safe dose and see how well it works in patients with various advanced cancers.

Will I have to stop taking my current medications?

The trial requires that you stop taking any investigational agents, chemotherapy, immunotherapy, radiotherapy, or molecular targeted agents at least 28 days before enrolling. If you are taking warfarin, you will need to stop, but low-dose or therapeutic heparin is allowed.

Who Is on the Research Team?

Jennifer Spratlin, MD

Principal Investigator

Alberta Health Services, University of Alberta

Are You a Good Fit for This Trial?

Adults with certain types of recurrent or metastatic solid tumors, who have tried other treatments without success or for whom no standard treatment exists. They must be in good health otherwise, with normal organ and marrow function, and not currently receiving other cancer therapies. Women can't be pregnant or nursing, and all participants must agree to use contraception.

Inclusion Criteria

Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures

Life expectancy of greater than 12 weeks

Normal organ and marrow function as defined below: absolute neutrophil count ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10^9/L, total bilirubin ≤ 1.5 X upper limit of normal (ULN), AST(SGOT) and ALT(SGPT) ≤ 2.5 X ULN (≤ 5 X ULN in the presence of liver metastases), Creatinine (Cr) ≤ 1.5 X ULN, Cardiac ejection fraction by echocardiogram must be >50% at baseline, Baseline ECG with QTc ≤ 470msec for females and ≤ 450msec for males, Agree to use adequate contraception for the duration of study participation and for 12 months after receiving the final dose of study drug, Ability and willingness to adhere to study required procedures, Patient must have measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria

Exclusion Criteria

I am on warfarin or low-dose heparin treatments.

Pregnant or nursing women

Human Immunodeficiency Virus (HIV)-positive patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

CCI-001 is administered at escalating doses to determine the maximum tolerated dose

28 days

Cycle 1 Days 1 and 15, Cycle 2 Day 1

Dose Expansion

Patients with specific tumour types are treated at the recommended dose determined during dose escalation

28 days

Cycle 1 Days 1 and 15, Cycle 2 Day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Imaging every 8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CCI-001

Trial Overview CCI-001 is a new drug related to colchicine being tested for safety and effective dosage in patients with specific cancers that are known to respond to similar drugs. This first-in-human trial will also look at how the body processes CCI-001 and its impact on tumor size and patient survival.

How Is the Trial Designed?

Group I: Dose Escalation and Expansion Experimental Treatment 1 Intervention

Dose escalation phase: CCI-001 will be administered at the starting dose to a cohort of patients with recurrent and/or metastatic solid tumours. The dose will be escalated sequentially in subsequent cohorts to determine the maximum tolerated dose, or recommended dose for the dose expansion cohort. Dose expansion phase: patients with the following tumour types will be permitted to enroll: transitional cell bladder cancer, pancreaticobiliary adenocarcinomas, gynecologic cancers (ovarian, cervical, endometrial), and lung adenocarcinoma. These patients will be treated at the dose determined during the dose escalation phase.

Who Is Running the Clinical Trial?

PharmaMatrix Holdings Ltd

Lead Sponsor

Trials

1

Recruited

70+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+