CancerPhase 1/2NCT04260802
A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers
A Phase 1/2 study testing OC-001 and Drug: OC-001 in Combination with Avelumab in people with Cancer and Neoplasms, run by Ocellaris Pharma, Inc. at 5 sites in Canada.
Trial summary
This study will investigate OC-001 as monotherapy, and in combination with, Avelumab, in various cancer types Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Neoplasms, Metastatic Cancer
- What is being tested?
- OC-001 and Drug: OC-001 in Combination with Avelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 5 sitesCanada
- Study dates
- 24 Sep 2020to 7 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
None listed.
Who cannot join
- Have symptomatic central nervous system (CNS) metastasis. Patients with treated CNS metastases are eligible for this study if they are asymptomatic and off of corticosteroids for a minimum of 7 days. Patients with primary brain tumors are not eligible
- Have a history of major organ transplant (e.g., heart, lungs, liver, and kidney) or an autologous or allogeneic hematopoietic stem cell transplant
- Females who are pregnant or nursing
- Have known, symptomatic acquired immuno deficiency syndrome (AIDS) or active hepatitis A, B or C
- Previous treatment-related, severe (≥Grade 3) Adverse Event (AE) or any neurologic or ocular AE while receiving an IO agent
- Active or prior documented autoimmune disease within the past 2 years Patients with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within the past 2 years are eligible
Show all 13Show fewer
- Active or prior documented inflammatory bowel disease
- History of tuberculosis, interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required corticosteroid therapy
- Receipt of live attenuated vaccination within 28 days prior
- Current or prior use of immunosuppressive medication within 28 days prior
- Are currently enrolled in another clinical study of an investigational medicinal product
- Have a second primary malignancy that may affect the interpretation of results
- Are unwilling or unable to participate in, or do not have tissue adequate for a tumor biopsy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
Jewish General Hospital - Clinical Research Unit
Montreal, Quebec, H3T 1E2
Ottawa Hospital Cancer Centre (OHRI)
Ottawa, Ontario
Princess Margaret Hospital
Toronto, Ontario, M5G 2C1
About this study
Official title: A Phase 1b/2a Two-Part, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of OC-001 as Monotherapy and in Combination With an Anti-PD-1/Anti-PD-L1 Antibody in Patients With Selected Locally Advanced or Metastatic Cancers
This study will investigate OC-001 as monotherapy, and in combination with, Avelumab, in various cancer types
- Conditions
- Cancer, Neoplasms, Metastatic Cancer, Triple Negative Breast Cancer, Gastric Cancer, Cervical Cancer
- Being tested
- OC-001, Drug: OC-001 in Combination with Avelumab
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Triple Negative Breast Neoplasms, Stomach Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Carcinoma, Hepatocellular, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC-001Drug
Administered IV.
Drug: OC-001 in Combination with AvelumabDrug
Administered IV.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Phase 1b: Dose Escalation (monotherapy) | Experimental | Escalating doses of OC-001 administered intravenously (IV) |
| Drug: Phase 1b Dose: Escalation (Combination therapy) | Experimental | Escalating doses of OC-001 administered by IV in combination Avelumab. Receives: Drug: Drug: OC-001 in Combination with Avelumab |
| Drug: Phase 2a | Experimental | Doses of OC-001 administered by IV in combination with Avelumab b) Receives: Drug: Drug: OC-001 in Combination with Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b
A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the criteria identified in the Common Terminology Criteria for Adverse Events (CTCAE, Version 5)
Measured: Baseline through Cycle 1 (Day 28)
Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a
Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a
Measured: Baseline up to two years
Secondary outcomes (14)
Area Under the OC-001 Plasma Concentration Time Curve (AUC) in Phase 1b
After single and multiple dose administration
Measured: Baseline through 12 weeks
Maximum Observed OC-001 Concentration (Cmax) in Phase 1b
After single and multiple dose administration
Measured: Baseline through 12 weeks
Time to reach OC-001 Cmax (Tmax) in Phase 1b
Time of maximum concentration observed
Measured: Baseline through 12 weeks
Minimum Observed OC-001 Concentration (Cmin) in Phase 1b
After single and multiple dose administration
Measured: Baseline through 12 weeks
Overall Response Rate (ORR) in Phase 2a
In combination with Avelumab
Measured: Baseline up to two years
Progression Free Survival (PFS) in Phase 2a
In combination with Avelumab
Measured: Baseline up to two years
Duration of Response (DOR) in Phase 2a
In combination with Avelumab
Measured: Baseline up to two years
Time to Response (TTR) in Phase 2a
In combination with Avelumab
Measured: Baseline up to two years
Disease Control Rate (DCR) in Phase 2a
In combination with Avelumab
Measured: Baseline up to two years
Overall Survival (OS) in Phase 2a
In combination with Avelumab
Measured: Baseline up to two years
One-Year Survival Rate in Phase 2a
In combination with Avelumab
Measured: Baseline up to two years
Maximum Observed OC-001 Concentration (Cmax) in Phase 2a
In combination with Avelumab
Measured: Baseline through 12 weeks
Minimum Observed OC-001 Concentration (Cmin) in Phase 2a
In combination with Avelumab
Measured: Baseline through 12 weeks
Trough drug concentration of OC-001 (Ctrough) in Phase 2a
In combination with Avelumab
Measured: Baseline through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start24 Sep 2020
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocellaris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ocellaris Pharma, Inc, Study director, Ocellaris Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260802
- Sponsor's protocol ID
- OCEL-01
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2020
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Two-Part, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of OC-001 as Monotherapy and in Combination With an Anti-PD-1/Anti-PD-L1 Antibody in Patients With Selected Locally Advanced or Metastatic Cancers
- ClinicalTrials.gov ID
- NCT04260802
- Acronym / sponsor ID
- OCEL-01
- Conditions
- Cancer, Neoplasms, Metastatic Cancer, Triple Negative Breast Cancer, Gastric Cancer, Cervical Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ocellaris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 7 Feb 2020 (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.
This study will investigate OC-001 as monotherapy, and in combination with, Avelumab, in various cancer types
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug: Phase 1b: Dose Escalation (monotherapy) | Experimental | –Escalating doses of OC-001 administered intravenously (IV) |
| Drug: Phase 1b Dose: Escalation (Combination therapy) | Experimental | Drug: Drug: OC-001 in Combination with AvelumabEscalating doses of OC-001 administered by IV in combination Avelumab. |
| Drug: Phase 2a | Experimental | Drug: Drug: OC-001 in Combination with AvelumabDoses of OC-001 administered by IV in combination with Avelumab b) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
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 |
|---|---|---|
| OC-001Administered IV. | Drug | – |
| Drug: OC-001 in Combination with AvelumabAdministered IV. | Drug | Drug: Phase 1b Dose: Escalation (Combination therapy), Drug: Phase 2a |
Primary outcome
Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b
Time frame: Baseline through Cycle 1 (Day 28)
A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the criteria identified in the Common Terminology Criteria for Adverse Events (CTCAE, Version 5)
Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a
Time frame: Baseline up to two years
Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a
14 secondary outcomes
Area Under the OC-001 Plasma Concentration Time Curve (AUC) in Phase 1b
Time frame: Baseline through 12 weeks
Maximum Observed OC-001 Concentration (Cmax) in Phase 1b
Time frame: Baseline through 12 weeks
Time to reach OC-001 Cmax (Tmax) in Phase 1b
Time frame: Baseline through 12 weeks
Minimum Observed OC-001 Concentration (Cmin) in Phase 1b
Time frame: Baseline through 12 weeks
Overall Response Rate (ORR) in Phase 2a
Time frame: Baseline up to two years
Progression Free Survival (PFS) in Phase 2a
Time frame: Baseline up to two years
Duration of Response (DOR) in Phase 2a
Time frame: Baseline up to two years
Time to Response (TTR) in Phase 2a
Time frame: Baseline up to two years
Disease Control Rate (DCR) in Phase 2a
Time frame: Baseline up to two years
Overall Survival (OS) in Phase 2a
Time frame: Baseline up to two years
One-Year Survival Rate in Phase 2a
Time frame: Baseline up to two years
Maximum Observed OC-001 Concentration (Cmax) in Phase 2a
Time frame: Baseline through 12 weeks
Minimum Observed OC-001 Concentration (Cmin) in Phase 2a
Time frame: Baseline through 12 weeks
Trough drug concentration of OC-001 (Ctrough) in Phase 2a
Time frame: Baseline through 12 weeks
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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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. This study is not recruiting at the moment.
Ocellaris Pharma, Inc study director
Ocellaris Pharma, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OC-001 and Drug: OC-001 in Combination with Avelumab in people with Cancer and Neoplasms, run by Ocellaris Pharma, Inc. at 5 sites 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 0 inclusion and 13 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: stopped early, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b (time frame: Baseline through Cycle 1 (Day 28)). 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 12 Jan 2026.