Cancer: Recurrent and/or Metastatic Solid TumoursPhase 1NCT04823897
A Phase I Open-Label, Single-Arm, Dose-Escalation Clinical and Pharmacology Study of CCI-001 as Monotherapy and in Combination With Standard Chemotherapy in Patients With Recurrent and/or Metastatic Solid Tumours
A Phase 1 study testing CCI-001 in people with Cancer: Recurrent and/or Metastatic Solid Tumours, run by PharmaMatrix Holdings Ltd at 1 site in Canada.
Trial summary
CCI-001 is a novel colchicine derivative that is being developed by PharmaMatrix Holdings Ltd. (PharmaMatrix). The drug binds to tubulin, a component of the microtubule polymers which are required for a wide range of cellular processes, perhaps most importantly, cell division and mitosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer: Recurrent and/or Metastatic Solid Tumours
- What is being tested?
- CCI-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jul 2021to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unless otherwise noted, inclusion criteria apply to all Parts of the protocol.
- Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures.
- Patients must have histologically or cytologically confirmed recurrent or metastatic solid tumours. For Part 1 and Part 2, patients must have disease progression on their last treatment, have exhausted available approved lines of therapy or better-characterized therapies that, at the discretion of the Investigator, are felt to be more appropriate therapy, or have malignancies for which there are no approved therapies. For Part 3, patients must have disease progression on their last treatment and have been treated with up to 3 approved lines of chemotherapy.
- For Part 3, only patients of the following tumour types will be permitted to enroll: gynecologic cancers (ovarian, fallopian tube, cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours [including esophageal, gastroesophageal junction and stomach]).
- For Part 3, patients' tumours must be deemed to be sensitive to the planned chemotherapy regimens (gemcitabine for pancreaticobiliary adenocarcinomas carboplatin for lung adenocarcinomas and gemcitabine or carboplatin for gynecologic cancers) to be allowed to enroll in the study.
- Four weeks must have elapsed since prior chemotherapy, hormonal therapy, targeted therapy, or radiation therapy. There is no restriction in the amount of bone marrow previously radiated.
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- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
- Recovery to baseline or Grade 1 for all drug-related toxicities due to prior chemotherapy, radiation, hormonal therapy, or molecular targeted therapy, except for alopecia, nausea, diarrhea and constipation.
- Age >18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) <1.
- Life expectancy of greater than 12 weeks.
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count ≥ 1.5 x 10˄9/L/L
- hemoglobin ≥ 90 g/L
- platelets ≥ 100 x 10˄9/L/L
- total bilirubin ≤ 1.5 x Upper limit of normal (ULN)
- AST (SGOT) and ALT(SGPT) ≤ 2.5 x ULN (≤ 5 x ULN for liver metastases)
- Creatinine (Cr) ≤ 1.5 x ULN
- All other laboratory assessments must be ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5.
- Cardiac ejection fraction by echocardiogram must be >50% for patients at baseline. Any structural changes found must be reviewed by the treating investigator and deemed acceptable and safe prior to study enrolment. Any noted cardiac fibrosis will exclude a patient.
- Baseline ECG with QTc ≤ 470 msec for females and ≤ 450 msec for men.
- Agree to use adequate contraception (see Section 8.7) during the study and for 12 months after receiving the final dose of study drug.
- Ability and willingness to adhere to study-required procedures.
Who cannot join
- Patients may not be receiving any other investigational agents, chemotherapy, immunotherapy, radiotherapy, or molecular targeted agents within 28 days prior to enrollment to study.
- Patients previously exposed to CCI-001 are not permitted to re-enroll.
- Patients may not have symptomatic CNS metastasis. Patients with treated CNS metastasis are eligible, provided their disease is radiographically stable over a period of ≥ 8 weeks, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants for the treatment of the symptoms from their brain metastases. Screening of asymptomatic patients without a history of CNS metastasis is not required.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-001 such as other derivatives of colchicine.
- History of allergic reactions or intolerance to anticipated chemotherapeutic agents.
- The presence of Grade 2 or higher peripheral neuropathy due to a prior medical condition (such as multiple sclerosis), medications, or other etiologies.
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- Any psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing women.
- Human Immunodeficiency Virus (HIV)-positive patients.
- Hepatitis B- and/or C-positive patients. A negative test is required at screening.
- History of other invasive cancer within 2 years of study entry. The exceptions are in situ cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, and localized prostate cancer after curative therapy such as surgery, or radiation (Gleason score < 7). For these exceptions, all treatment must have been completed at least 6 months prior to enrollment.
- Patients taking warfarin. Low dose or therapeutic dose of heparin or low molecular weight heparin is allowed.
- Cardiac fibrosis on echocardiogram.
- Adherence to all inclusion and exclusion criteria is mandatory; no waivers will be granted.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Jennifer Spratlin, MD, 780 432-8514, jennifer.spratlin@albertahealthservices.ca
About this study
CCI-001 is a novel colchicine derivative that is being developed by PharmaMatrix Holdings Ltd. (PharmaMatrix). The drug binds to tubulin, a component of the microtubule polymers which are required for a wide range of cellular processes, perhaps most importantly, cell division and mitosis. CCI-001 has been shown to bind more strongly to β-III tubulin, a tubulin subtype which is overexpressed in many cancers.
This trial is being undertaken as a first-in-human, Phase I trial in patients with recurrent and/or metastatic solid tumours. Primary Objectives are to examine the compound's safety profile, and to determine the recommended dose. Secondary Objectives are to determine the compound's pharmacokinetic parameters and to evaluate the clinical response rate (objective response rate and progression-free survival).
Read more
Expansion cohorts (Parts 2 and 3) will enroll patients with the following tumour types: gynecologic cancers (ovarian [including fallopian tube and primary peritoneal], cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours [including esophageal, gastroesophageal junction and stomach]).
Part 2 Expansion cohorts will be treated at the recommended dose.
Part 3 Expansion cohorts will be treated at a CCI-001 dose lower than the recommended dose in combination with either gemcitabine or cisplatin.
- Being tested
- CCI-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCI-001Drug
Part 1 Dose Escalation: CCI-001 will be given intravenously starting at 1.2mg/m2 in the first cohort. The dose escalation between cohorts will depend on adverse event grading, as judged by NCI-CTCAE. Part 1 is complete when the maximum tolerated dose and the recommended expansion dose are determined.
Part 2 Dose Expansion: cohorts of patients with the following tumour types will be enrolled: gynecologic cancers (ovarian [including fallopian tube and primary peritoneal], cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours [including esophageal, gastroesophageal junction and stomach]). These patients will receive the Part 1 recommended CCI-001 dose.
In Part 3 Dose Expansion: CCI-001 with Gemcitabine or Carboplatin, the same Part 2 tumour types will be treated at approved doses of gemcitabine or carboplatin, with CCI-001 below the recommended dose.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Part 1 Dose-Escalation: CCI-001 will be given 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, and the recommended dose for dose expansions.
Part 2 CCI-001 Monotherapy Dose Expansion: patients with these tumour types will be enrolled: gynecologic cancers (ovarian [including fallopian tube and primary peritoneal], cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours [including esophageal, gastroesophageal junction and stomach]). Patients will receive the Part 1 recommended dose.
Part 3 Dose Expansion: CCI-001 with Gemcitabine or Carboplatin will enroll the same tumour types as Part 2. Treatment will be at approved doses of gemcitabine or carboplatin, with CCI-001 started at less than the recommended dose. Receives: Drug: CCI-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine (Part 1) and confirm (Part 2) the safety of the recommended dose of intravenous CCI-001 monotherapy, and to examine the safety of CCI-001 with gemcitabine or carboplatin (Part 3) for patients with recurrent or metastatic solid tumours.
DLT in this study will be determined against a pre-defined set of criteria based on the NCI-CTCAE v. 5.0 grading system.
Measured: Cycle 1 (28 days)
To determine, during the Part 1 dose-escalation, the recommended dose of intravenously infused CCI-001 for the dose expansion part of the trial.
The recommended dose will be the dose level below that for the cohort in which maximum tolerated dose (MTD) was reached/exceeded. MTD will have been reached when 2 or more patients in a cohort experience DLT.
Measured: Cycle 1 (28 days)
Secondary outcomes (6)
To evaluate clinical response (objective response rate and progression-free survival) in patients with recurrent and/or metastatic solid tumours, treated with CCI-001 monotherapy (Parts 1, 2), or combined with gemcitabine or carboplatin (Part 3).
All patients with measurable disease will be assessed by standard criteria. Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria will be utilized to determine response based on CT and/or MRI scans.
Measured: Patients will have a baseline scan prior to dosing, and re-evaluated with imaging every 8 weeks. To continue from baseline scan to first documented date of disease progression, or date of death from any cause.
To evaluate survival in patients treated with CCI-001 with recurrent and/or metastatic solid tumours, with particular attention to those in expansion cohorts
Descriptive statistics will be utilized to evaluate patient survival.
Measured: Start of treatment period (Cycle 1, Day1) to 30 days past the last treatment. Each Cycle is 28 days.
To determine the time to maximum plasma level (Tmax) of CCI-001 administered intravenously.
Tmax is the time at which the maximum plasma CCI-001 concentration is achieved.
Measured: Measured on Cycle 1 Days 1 and 15, Cycle 2 Day 1. Each cycle is 28 days.
To determine the maximum plasma concentration (Cmax) of CCI-001 administered intravenously.
Cmax is the maximum plasma CCI-001 concentration that is achieved post-administration.
Measured: Measured on Cycle 1 Days 1 and 15, Cycle 2 Day 1. Each cycle is 28 days.
To determine the area under the curve (AUC) of CCI-001 administered intravenously.
AUC is the measure of total CCI-001 exposure after administration.
Measured: Measured on Cycle 1 Days 1 and 15, Cycle 2 Day 1. Each cycle is 28 days.
To determine the terminal half life (t1/2) of CCI-001 administered intravenously.
t1/2 is the measure of the time it takes CCI-001 plasma concentration to decrease by 50%, after administration.
Measured: Measured on Cycle 1 Days 1 and 15, Cycle 2 Day 1. Each cycle is 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start26 Jul 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer: Recurrent and/or Metastatic Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is an open-label, single-arm, single-center, Phase I dose-escalation/expansion study of CCI-001 in patients with recurrent and/or metastatic solid tumours. Part 1 Escalation will treat cohorts of 3 patients, starting at 1.2 mg/m2 CCI-001. If safety criteria are met, the dose for each subsequent cohort will be escalated, using the modified accelerated dose-escalation method. A Cycle 1 dose-limiting toxicity (DLT) will trigger cohort expansion to 6 patients. A second DLT in a cohort indicates that the maximum tolerated dose (MTD) has been reached. If only 1 patient per cohort has a DLT, dose-escalation will continue in the next cohort. The cohort at the dose below the MTD will be expanded to 6 patients to ensure tolerability. If there are 1 or no DLTs in this cohort, this will be the recommended dose for the Part 2 CCI-001 Monotherapy Expansion. Part 3 Expansion in Combination with Gemcitabine or Carboplatin with CCI-001 at a dose lower than the recommended Part 2 dose.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaMatrix Holdings Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Responsible party
- Sponsor
- Investigators
- Jennifer Spratlin, MD, Principal investigator, Alberta Health Services, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823897
- Sponsor's protocol ID
- PMH-001
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Single-Arm, Dose-Escalation Clinical and Pharmacology Study of CCI-001 as Monotherapy and in Combination With Standard Chemotherapy in Patients With Recurrent and/or Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT04823897
- Acronym / sponsor ID
- PMH-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- PharmaMatrix Holdings LtdUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CCI-001 is a novel colchicine derivative that is being developed by PharmaMatrix Holdings Ltd. (PharmaMatrix). The drug binds to tubulin, a component of the microtubule polymers which are required for a wide range of cellular processes, perhaps most importantly, cell division and mitosis. CCI-001 has been shown to bind more strongly to β-III tubulin, a tubulin subtype which is overexpressed in many cancers.
This trial is being undertaken as a first-in-human, Phase I trial in patients with recurrent and/or metastatic solid tumours. Primary Objectives are to examine the compound's safety profile, and to determine the recommended dose. Secondary Objectives are to determine the compound's pharmacokinetic parameters and to evaluate the clinical response rate (objective response rate and progression-free survival).
Expansion cohorts (Parts 2 and 3) will enroll patients with the following tumour types: gynecologic cancers (ovarian [including fallopian tube and primary peritoneal], cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours [including esophageal, gastroesophageal junction and stomach]).
Part 2 Expansion cohorts will be treated at the recommended dose.
Part 3 Expansion cohorts will be treated at a CCI-001 dose lower than the recommended dose in combination with either gemcitabine or cisplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single-arm, single-center, Phase I dose-escalation/expansion study of CCI-001 in patients with recurrent and/or metastatic solid tumours. Part 1 Escalation will treat cohorts of 3 patients, starting at 1.2 mg/m2 CCI-001. If safety criteria are met, the dose for each subsequent cohort will be escalated, using the modified accelerated dose-escalation method. A Cycle 1 dose-limiting toxicity (DLT) will trigger cohort expansion to 6 patients. A second DLT in a cohort indicates that the maximum tolerated dose (MTD) has been reached. If only 1 patient per cohort has a DLT, dose-escalation will continue in the next cohort. The cohort at the dose below the MTD will be expanded to 6 patients to ensure tolerability. If there are 1 or no DLTs in this cohort, this will be the recommended dose for the Part 2 CCI-001 Monotherapy Expansion. Part 3 Expansion in Combination with Gemcitabine or Carboplatin with CCI-001 at a dose lower than the recommended Part 2 dose.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Drug: CCI-001Part 1 Dose-Escalation: CCI-001 will be given 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, and the recommended dose for dose expansions. Part 2 CCI-001 Monotherapy Dose Expansion: patients with these tumour types will be enrolled: gynecologic cancers (ovarian [including fallopian tube and primary peritoneal], cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours [including esophageal, gastroesophageal junction and stomach]). Patients will receive the Part 1 recommended dose. Part 3 Dose Expansion: CCI-001 with Gemcitabine or Carboplatin will enroll the same tumour types as Part 2. Treatment will be at approved doses of gemcitabine or carboplatin, with CCI-001 started at less than the recommended dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Unless otherwise noted, inclusion criteria apply to all Parts of the protocol.
- Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures.
- Patients must have histologically or cytologically confirmed recurrent or metastatic solid tumours. For Part 1 and Part 2, patients must have disease progression on their last treatment, have exhausted available approved lines of therapy or better-characterized therapies that, at the discretion of the Investigator, are felt to be more appropriate therapy, or have malignancies for which there are no approved therapies. For Part 3, patients must have disease progression on their last treatment and have been treated with up to 3 approved lines of chemotherapy.
- For Part 3, only patients of the following tumour types will be permitted to enroll: gynecologic cancers (ovarian, fallopian tube, cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours [including esophageal, gastroesophageal junction and stomach]).
- For Part 3, patients' tumours must be deemed to be sensitive to the planned chemotherapy regimens (gemcitabine for pancreaticobiliary adenocarcinomas carboplatin for lung adenocarcinomas and gemcitabine or carboplatin for gynecologic cancers) to be allowed to enroll in the study.
Key exclusion criteria (15 listed)
- Patients may not be receiving any other investigational agents, chemotherapy, immunotherapy, radiotherapy, or molecular targeted agents within 28 days prior to enrollment to study.
- Patients previously exposed to CCI-001 are not permitted to re-enroll.
- Patients may not have symptomatic CNS metastasis. Patients with treated CNS metastasis are eligible, provided their disease is radiographically stable over a period of ≥ 8 weeks, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants for the treatment of the symptoms from their brain metastases. Screening of asymptomatic patients without a history of CNS metastasis is not required.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-001 such as other derivatives of colchicine.
- History of allergic reactions or intolerance to anticipated chemotherapeutic agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCI-001Part 1 Dose Escalation: CCI-001 will be given intravenously starting at 1.2mg/m2 in the first cohort. The dose escalation between cohorts will depend on adverse event grading, as judged by NCI-CTCAE. Part 1 is complete when the maximum tolerated dose and the recommended expansion dose are determined. Part 2 Dose Expansion: cohorts of patients with the following tumour types will be enrolled: gynecologic cancers (ovarian [including fallopian tube and primary peritoneal], cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours [including esophageal, gastroesophageal junction and stomach]). These patients will receive the Part 1 recommended CCI-001 dose. In Part 3 Dose Expansion: CCI-001 with Gemcitabine or Carboplatin, the same Part 2 tumour types will be treated at approved doses of gemcitabine or carboplatin, with CCI-001 below the recommended dose. | Drug | Dose Escalation and Expansion |
Primary outcome
To determine (Part 1) and confirm (Part 2) the safety of the recommended dose of intravenous CCI-001 monotherapy, and to examine the safety of CCI-001 with gemcitabine or carboplatin (Part 3) for patients with recurrent or metastatic solid tumours.
Time frame: Cycle 1 (28 days)
DLT in this study will be determined against a pre-defined set of criteria based on the NCI-CTCAE v. 5.0 grading system.
To determine, during the Part 1 dose-escalation, the recommended dose of intravenously infused CCI-001 for the dose expansion part of the trial.
Time frame: Cycle 1 (28 days)
The recommended dose will be the dose level below that for the cohort in which maximum tolerated dose (MTD) was reached/exceeded. MTD will have been reached when 2 or more patients in a cohort experience DLT.
6 secondary outcomes
To evaluate clinical response (objective response rate and progression-free survival) in patients with recurrent and/or metastatic solid tumours, treated with CCI-001 monotherapy (Parts 1, 2), or combined with gemcitabine or carboplatin (Part 3).
Time frame: Patients will have a baseline scan prior to dosing, and re-evaluated with imaging every 8 weeks. To continue from baseline scan to first documented date of disease progression, or date of death from any cause.
To evaluate survival in patients treated with CCI-001 with recurrent and/or metastatic solid tumours, with particular attention to those in expansion cohorts
Time frame: Start of treatment period (Cycle 1, Day1) to 30 days past the last treatment. Each Cycle is 28 days.
To determine the time to maximum plasma level (Tmax) of CCI-001 administered intravenously.
Time frame: Measured on Cycle 1 Days 1 and 15, Cycle 2 Day 1. Each cycle is 28 days.
To determine the maximum plasma concentration (Cmax) of CCI-001 administered intravenously.
Time frame: Measured on Cycle 1 Days 1 and 15, Cycle 2 Day 1. Each cycle is 28 days.
To determine the area under the curve (AUC) of CCI-001 administered intravenously.
Time frame: Measured on Cycle 1 Days 1 and 15, Cycle 2 Day 1. Each cycle is 28 days.
To determine the terminal half life (t1/2) of CCI-001 administered intravenously.
Time frame: Measured on Cycle 1 Days 1 and 15, Cycle 2 Day 1. Each cycle is 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Spratlin, MD principal investigator
Alberta Health Services, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CCI-001 in people with Cancer: Recurrent and/or Metastatic Solid Tumours, run by PharmaMatrix Holdings Ltd at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Allard (780-430-2811, crallard@shaw.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine (Part 1) and confirm (Part 2) the safety of the recommended dose of intravenous CCI-001 monotherapy, and to examine the safety of CCI-001 with gemcitabine or carboplatin (Part 3) for patients with recurrent or metastatic solid tumours. (time frame: Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.