Pancreatic CancerPhase 1NCT05043987
Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers
A Phase 1 study testing CPO102 in people with Pancreatic Cancer and Gastric Cancer, run by Conjupro Biotherapeutics, Inc..
Trial summary
This Phase 1 study will be a multicenter, single agent, dose escalation and dose expansion study conducted in patients with advanced late stage cancer (pancreatic or gastric including esophageal junction cancers) for which the investigator determines there to be no other standard of care or higher priority therapies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Gastric Cancer
- What is being tested?
- CPO102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2022to 16 Nov 2022
- Phase
- Phase 1
- 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
- Applicable to all patients in both Part A and Part B of the study:
- Pathological diagnosis (histological) of pancreatic or gastric including esophageal junction cancers.
- Patient must provide archived tissue block or formalin-fixed paraffin-embedded (FFPE) slides or fresh biopsy prior to start of treatment.
- Positive claudin 18.2 tumor expression defined as ≥50% of tumor cells demonstrating moderate-to-strong membranous staining (2+/3+) by IHC assay performed on sections of tumor derived from formalin fixed paraffin block.
- Adequate organ function.
- Life expectancy >12 weeks.
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- Age ≥18 years.
- ECOG performance status 0 or 1 at screening.
- Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent.
- Patients of reproductive potential: All female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before study entry.
- Specific criteria for Part A:
- Disease progression or relapse following conventional chemotherapy:
- Pancreatic cancer
- Gastric cancer (including GEJ cancer)
- Specific criteria for Part B:
- Measurable disease suitable for imaging and efficacy tracking as defined by RECIST 1.1
- Disease progression or relapse following conventional chemotherapy:
- Pancreatic cancer
- Gastric cancer (including GEJ cancer)
Who cannot join
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to baseline or to common terminology criteria for adverse events (CTCAE) grade ≤1, with the exception of alopecia, ≥grade 2 neuropathy, or to the levels dictated in the inclusion/exclusion criteria.
- Patient has participated in any investigational research study and is being screened for participation within a period of 5 half-lives or 4 weeks, whichever is longer, of the last dose of the investigational therapy.
- History of severe infusion reaction with monoclonal antibody treatment.
- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening.
- HIV positive test within 8 weeks of screening.
- Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
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- Presence of other active cancers, or history of treatment for invasive cancer ≤3 years. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (ie, noninvasive) are eligible, as are patients with history of nonmelanoma skin cancer.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Active central nervous system (CNS) disease involvement, defined by cerebrospinal fluid (CSF) cytology, magnetic resonance imaging (MRI) or computerized tomography (CT); patients with asymptomatic CNS metastases are eligible if participants have been clinically stable for at least 4 weeks prior to the first dose of study drug and do not require interventions such as surgery, radiation or any corticosteroid therapy for management of symptoms related to CNS disease.
- Peripheral neuropathy Grades ≥ 2.
- Active ocular surface disease at baseline (based on ophthalmic evaluation).
- Pregnant or nursing (lactating) women.
- Patients who received claudin 18.2 targeting agents previously.
- Patients who have received or will receive coronavirus disease 2019 (COVID-19) vaccine within 72 hours prior to the first dose of study drug.
- Prior radiotherapy
About this study
Official title: A Phase 1, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate Safety of CPO102, an Anti-claudin 18.2 Antibody-MMAE Drug Conjugate Administered Intravenously in Patients With Advanced Pancreatic and Gastric Cancers
This Phase 1 study will be a multicenter, single agent, dose escalation and dose expansion study conducted in patients with advanced late stage cancer (pancreatic or gastric including esophageal junction cancers) for which the investigator determines there to be no other standard of care or higher priority therapies available.
Read the detailed description
This Phase 1 study will be a multicenter, single agent, dose escalation and dose expansion study conducted in patients with advanced late stage cancer (pancreatic or gastric including esophageal junction cancers) for which the investigator determines there to be no other standard of care or higher priority therapies available. All patients must have failed standard first or later lines of systemic therapy.
The study design overview is presented below. The study will consist of 2 parts, Part A and Part B. Part A will explore once every 3 weeks (Q3W) dosing per standard 3+3 dose escalation design. Upon attaining a RP2D, Part B will commence in 2 groups, in approximately 15 patients with advanced pancreatic cancer and 15 patients with advanced gastric including gastric esophageal junction cancers. Part B will seek to confirm the RP2D and will also seek early signals of efficacy in the selected cancer patient populations.
- Conditions
- Pancreatic Cancer, Gastric Cancer
- Being tested
- CPO102
- Keywords
- Claudin 18.2 ADC, Phase 1, CPO102, Pancreatic Cancer, Gastric Cancer
- Medical subject headings
- Pancreatic Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPO102Drug
Anti-claudin 18.2 Antibody-MMAE Drug Conjugate
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Part A will follow the standard 3+3 dose-escalation design and will be enrolled at dose levels of CPO102 at (0.5, 1, 1.8, 2.5, 3.5, 4.5, 5.5 mg/kg).
Each subject group will receive one dose of CPO-102 every 3 weeks (1 cycle=21 days=1 treatment). For each cohort, the decision whether to dose-escalate will be made once all patients have been enrolled into the cohort and the last patient enrolled has been followed for 21 days (3-week DLT observation period). Receives: Drug: CPO102 |
| Part B-Arm 1 | Experimental | Upon attaining a RP2D, Part B-Arm 1 will include approximately 15 patients with pancreatic cancer patients. This subject group will receive multiple cycles of a weekly dose of CPO-102 (1 cycle=21 days=1 treatment). Receives: Drug: CPO102 |
| Part B-Arm 2 | Experimental | Upon attaining a RP2D, Part B-Arm 2 will include approximately 15 gastric (including gastric esophageal junction) cancer patients. This subject group will receive multiple cycles of a weekly dose of CPO-102 (1 cycle=21 days=1 treatment). Receives: Drug: CPO102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities (DLTs) during the DLT evaluation period.
DLTs are assessed during the first cycle (21 days) in each cohort to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Measured: through study completion, an average of 3 year
Secondary outcomes (10)
Number of participants with treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship.
TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0.
Measured: through study completion, an average of 3 year
Number of participants with clinically significant changes in vital signs
Number of participants with clinically significant changes in vital signs
Measured: through study completion, an average of 3 year
Number of participants with clinically significant changes in clinical laboratory tests
Number of participants with clinically significant changes in clinical laboratory tests
Measured: through study completion, an average of 3 year
CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval.
CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval.
Measured: through study completion, an average of 3 year
CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax)
CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax)
Measured: through study completion, an average of 3 year
CPO102 pharmacokinetics: Time to maximum concentration (Tmax)
CPO102 pharmacokinetics: Time to maximum concentration (Tmax)
Measured: through study completion, an average of 3 year
CPO102 pharmacokinetics: Elimination half-life (t1/2)
CPO102 pharmacokinetics: Elimination half-life (t1/2)
Measured: through study completion, an average of 3 year
CPO102 pharmacokinetics: Clearance (CL)
CPO102 pharmacokinetics: Clearance (CL)
Measured: through study completion, an average of 3 year
CPO102 Objective response rate (ORR)
ORR is defined as the proportion of patients in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 is observed as best overall response.
Measured: through study completion, an average of 3 year
CPO102 immunogenicity: Number of participants with anti-drug-antibody (ADA)
CPO102 immunogenicity: Number of participants with anti-drug-antibody (ADA)
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start16 Nov 2022
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Why it stopped: New IND sponsor to initiate a separate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conjupro Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Jiangfeng Su, MD, PhD, Study director, Conjupro Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043987
- Sponsor's protocol ID
- CPO102-US-1001
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate Safety of CPO102, an Anti-claudin 18.2 Antibody-MMAE Drug Conjugate Administered Intravenously in Patients With Advanced Pancreatic and Gastric Cancers
- ClinicalTrials.gov ID
- NCT05043987
- Acronym / sponsor ID
- CPO102-US-1001
- Conditions
- Pancreatic Cancer, Gastric Cancer
- Keywords
- Claudin 18.2 ADC, Phase 1, CPO102, Pancreatic Cancer, Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New IND sponsor to initiate a separate study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Conjupro Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 14 Sep 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.
This Phase 1 study will be a multicenter, single agent, dose escalation and dose expansion study conducted in patients with advanced late stage cancer (pancreatic or gastric including esophageal junction cancers) for which the investigator determines there to be no other standard of care or higher priority therapies available.
Detailed description
This Phase 1 study will be a multicenter, single agent, dose escalation and dose expansion study conducted in patients with advanced late stage cancer (pancreatic or gastric including esophageal junction cancers) for which the investigator determines there to be no other standard of care or higher priority therapies available. All patients must have failed standard first or later lines of systemic therapy.
The study design overview is presented below. The study will consist of 2 parts, Part A and Part B. Part A will explore once every 3 weeks (Q3W) dosing per standard 3+3 dose escalation design. Upon attaining a RP2D, Part B will commence in 2 groups, in approximately 15 patients with advanced pancreatic cancer and 15 patients with advanced gastric including gastric esophageal junction cancers. Part B will seek to confirm the RP2D and will also seek early signals of efficacy in the selected cancer patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: CPO102Part A will follow the standard 3+3 dose-escalation design and will be enrolled at dose levels of CPO102 at (0.5, 1, 1.8, 2.5, 3.5, 4.5, 5.5 mg/kg). Each subject group will receive one dose of CPO-102 every 3 weeks (1 cycle=21 days=1 treatment). For each cohort, the decision whether to dose-escalate will be made once all patients have been enrolled into the cohort and the last patient enrolled has been followed for 21 days (3-week DLT observation period). |
| Part B-Arm 1 | Experimental | Drug: CPO102Upon attaining a RP2D, Part B-Arm 1 will include approximately 15 patients with pancreatic cancer patients. This subject group will receive multiple cycles of a weekly dose of CPO-102 (1 cycle=21 days=1 treatment). |
| Part B-Arm 2 | Experimental | Drug: CPO102Upon attaining a RP2D, Part B-Arm 2 will include approximately 15 gastric (including gastric esophageal junction) cancer patients. This subject group will receive multiple cycles of a weekly dose of CPO-102 (1 cycle=21 days=1 treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Pathological diagnosis (histological) of pancreatic or gastric including esophageal junction cancers.
- Patient must provide archived tissue block or formalin-fixed paraffin-embedded (FFPE) slides or fresh biopsy prior to start of treatment.
- Positive claudin 18.2 tumor expression defined as ≥50% of tumor cells demonstrating moderate-to-strong membranous staining (2+/3+) by IHC assay performed on sections of tumor derived from formalin fixed paraffin block.
- Adequate organ function.
- Life expectancy >12 weeks.
Key exclusion criteria (15 listed)
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to baseline or to common terminology criteria for adverse events (CTCAE) grade ≤1, with the exception of alopecia, ≥grade 2 neuropathy, or to the levels dictated in the inclusion/exclusion criteria.
- Patient has participated in any investigational research study and is being screened for participation within a period of 5 half-lives or 4 weeks, whichever is longer, of the last dose of the investigational therapy.
- History of severe infusion reaction with monoclonal antibody treatment.
- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening.
- HIV positive test within 8 weeks of screening.
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 |
|---|---|---|
| CPO102Anti-claudin 18.2 Antibody-MMAE Drug Conjugate | Drug | Part A, Part B-Arm 1, Part B-Arm 2 |
Primary outcome
Number of participants with dose-limiting toxicities (DLTs) during the DLT evaluation period.
Time frame: through study completion, an average of 3 year
DLTs are assessed during the first cycle (21 days) in each cohort to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
10 secondary outcomes
Number of participants with treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship.
Time frame: through study completion, an average of 3 year
Number of participants with clinically significant changes in vital signs
Time frame: through study completion, an average of 3 year
Number of participants with clinically significant changes in clinical laboratory tests
Time frame: through study completion, an average of 3 year
CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval.
Time frame: through study completion, an average of 3 year
CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax)
Time frame: through study completion, an average of 3 year
CPO102 pharmacokinetics: Time to maximum concentration (Tmax)
Time frame: through study completion, an average of 3 year
CPO102 pharmacokinetics: Elimination half-life (t1/2)
Time frame: through study completion, an average of 3 year
CPO102 pharmacokinetics: Clearance (CL)
Time frame: through study completion, an average of 3 year
CPO102 Objective response rate (ORR)
Time frame: through study completion, an average of 3 year
CPO102 immunogenicity: Number of participants with anti-drug-antibody (ADA)
Time frame: through study completion, an average of 3 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No. Undecided
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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.
Jiangfeng Su, MD, PhD study director
Conjupro Biotherapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPO102 in people with Pancreatic Cancer and Gastric Cancer, run by Conjupro Biotherapeutics, Inc..
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 19 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: withdrawn, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 dose-limiting toxicities (DLTs) during the DLT evaluation period. (time frame: through study completion, an average of 3 year). 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 7 Sep 2023.