Metastatic Castration-Resistant Prostate AdenocarcinomaPhase 1NCT04077021
First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer
A Phase 1 study testing CCW702 in people with Metastatic Castration-Resistant Prostate Adenocarcinoma, run by Calibr, a division of Scripps Research at 5 sites in United States.
Trial summary
CCW702 is an investigational immunotherapy for prostate cancer. This is a two-part, first-in-human study to assess the safety and tolerability of CCW702 administered subcutaneously to patients with metastatic, castration resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Adenocarcinoma
- What is being tested?
- CCW702
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Jul 2020to 21 Oct 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥ 18 years of age at time of informed consent
- For Part 1 and Part 2: men with metastatic castration resistant prostate cancer (mCRPC) with histologically or cytologically confirmed adenocarcinoma of the prostate as defined by one or more of the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
- Patients with treated brain metastasis or LMD are eligible if brain imaging shows no evidence of progression
- Must have prostate-specific antigen (PSA) and/or radiographic progression on AT LEAST One novel androgen receptor (AR)-targeted therapy (abiraterone acetate, enzalutamide).
- Eastern Cooperative Oncology Group performance status of 0-1
- Adequate liver function
Show all 9Show fewer
- Adequate hematopoietic function
- Testosterone level ≤ 50 ng/mL (or 1.73 nmol/L)
- Patient has a life expectancy of greater than 12 weeks
Who cannot join
- Patients whose tumors solely exhibit neuroendocrine differentiation or small cell features by histopathology
- Patients with new or progressive brain metastasis or Leptomeningeal Disease (LMD)
- Patients with a history of clinically significant cardiovascular disease such as symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of stroke or myocardial infarction within 6 months of enrollment
- Patients with peripheral neuropathy CTCAE Grade >/= 2
- Patients with a known history of hypersensitivity, allergy or intolerance to CCW702 or its excipients
- Patients with untreated or imminent spinal cord compression
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
University of Virginia
Charlottesville, Virginia, 22908
Karmanos Cancer Institute
Detroit, Michigan, 48201
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of California at San Diego
San Diego, California, 92093
About this study
Official title: A Phase 1, Open-label Study in Two Parts, Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of CCW702 in Patients With Metastatic, Castration Resistant Prostate Adenocarcinoma
CCW702 is an investigational immunotherapy for prostate cancer. This is a two-part, first-in-human study to assess the safety and tolerability of CCW702 administered subcutaneously to patients with metastatic, castration resistant prostate cancer. Part I is divided in to two subparts, in both subparts patients will receive ascending dosages of CCW702 with the goal to determine the maximum tolerated dose (MTD) of CCW702 and efficacious regimen. Part Ia will explore every other other day dosing (QOD); Part Ib will explore weekly dosing (Q7D). In part II of the study, patients will be given the recommended part/phase 2 dose (RP2D) Q7D. The study will also assess the pharmacokinetics and pharmacodynamics of CCW702.
- Being tested
- CCW702
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCW702Drug
Investigational immunotherapy for prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: Dose Escalation QOD | Experimental | CCW702 administered subcutaneously QOD, dose escalating cohorts. Receives: Drug: CCW702 |
| Part 1b: Dose Escalation Q7D | Experimental | CCW702 administered subcutaneously Q7D, dose escalating cohorts. Receives: Drug: CCW702 |
| Part 2: Dose Expansion | Experimental | CCW702 administered subcutaneously Q7D at RP2D. Receives: Drug: CCW702 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities
Frequency, severity, duration of treatment-emergent and treatment-related adverse events per CTCAE v5.0
Measured: up to day 28
Part 1a and 1b: Select recommended phase/part 2 dose
Review of safety and tolerability data (adverse events, dosing) based on CTCAE v5 of all Part 1 subjects/cohorts
Measured: up to 2 years
Part 2: to assess clinical efficacy at the RP2D
Responses will be measured using prostate cancer working group 3 (PCWG3) criteria
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start17 Jul 2020
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-Resistant Prostate AdenocarcinomaStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calibr, a division of Scripps Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077021
- Sponsor's protocol ID
- CBR-CCW702-3001
- Status last verified
- May 2023
- First submitted
- 20 Aug 2019
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim CH, Axup JY, Lawson BR, Yun H, Tardif V, Choi SH, Zhou Q, Dubrovska A, Biroc SL, Marsden R, Pinstaff J, Smider VV, Schultz PG. Bispecific small molecule-antibody conjugate targeting prostate cancer. Proc Natl Acad Sci U S A. 2013 Oct 29;110(44):17796-801. doi: 10.1073/pnas.1316026110. Epub 2013 Oct 14.
PubMed 24127589Lee SC, Ma JSY, Kim MS, Laborda E, Choi SH, Hampton EN, Yun H, Nunez V, Muldong MT, Wu CN, Ma W, Kulidjian AA, Kane CJ, Klyushnichenko V, Woods AK, Joseph SB, Petrassi M, Wisler J, Li J, Jamieson CAM, Schultz PG, Kim CH, Young TS. A PSMA-targeted bispecific antibody for prostate cancer driven by a small-molecule targeting ligand. Sci Adv. 2021 Aug 11;7(33):eabi8193. doi: 10.1126/sciadv.abi8193. Print 2021 Aug.
PubMed 34380625
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study in Two Parts, Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of CCW702 in Patients With Metastatic, Castration Resistant Prostate Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04077021
- Acronym / sponsor ID
- CBR-CCW702-3001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Calibr, a division of Scripps ResearchUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 4 Sep 2019 (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.
CCW702 is an investigational immunotherapy for prostate cancer. This is a two-part, first-in-human study to assess the safety and tolerability of CCW702 administered subcutaneously to patients with metastatic, castration resistant prostate cancer. Part I is divided in to two subparts, in both subparts patients will receive ascending dosages of CCW702 with the goal to determine the maximum tolerated dose (MTD) of CCW702 and efficacious regimen. Part Ia will explore every other other day dosing (QOD); Part Ib will explore weekly dosing (Q7D). In part II of the study, patients will be given the recommended part/phase 2 dose (RP2D) Q7D. The study will also assess the pharmacokinetics and pharmacodynamics of CCW702.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1a: Dose Escalation QOD | Experimental | Drug: CCW702CCW702 administered subcutaneously QOD, dose escalating cohorts. |
| Part 1b: Dose Escalation Q7D | Experimental | Drug: CCW702CCW702 administered subcutaneously Q7D, dose escalating cohorts. |
| Part 2: Dose Expansion | Experimental | Drug: CCW702CCW702 administered subcutaneously Q7D at RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men ≥ 18 years of age at time of informed consent
- For Part 1 and Part 2: men with metastatic castration resistant prostate cancer (mCRPC) with histologically or cytologically confirmed adenocarcinoma of the prostate as defined by one or more of the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
- Patients with treated brain metastasis or LMD are eligible if brain imaging shows no evidence of progression
- Must have prostate-specific antigen (PSA) and/or radiographic progression on AT LEAST One novel androgen receptor (AR)-targeted therapy (abiraterone acetate, enzalutamide).
- Eastern Cooperative Oncology Group performance status of 0-1
Key exclusion criteria (6 listed)
- Patients whose tumors solely exhibit neuroendocrine differentiation or small cell features by histopathology
- Patients with new or progressive brain metastasis or Leptomeningeal Disease (LMD)
- Patients with a history of clinically significant cardiovascular disease such as symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of stroke or myocardial infarction within 6 months of enrollment
- Patients with peripheral neuropathy CTCAE Grade >/= 2
- Patients with a known history of hypersensitivity, allergy or intolerance to CCW702 or its excipients
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 |
|---|---|---|
| CCW702Investigational immunotherapy for prostate cancer | Drug | Part 1a: Dose Escalation QOD, Part 1b: Dose Escalation Q7D, Part 2: Dose Expansion |
Primary outcome
Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities
Time frame: up to day 28
Frequency, severity, duration of treatment-emergent and treatment-related adverse events per CTCAE v5.0
Part 1a and 1b: Select recommended phase/part 2 dose
Time frame: up to 2 years
Review of safety and tolerability data (adverse events, dosing) based on CTCAE v5 of all Part 1 subjects/cohorts
Part 2: to assess clinical efficacy at the RP2D
Time frame: up to 2 years
Responses will be measured using prostate cancer working group 3 (PCWG3) criteria
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 May 2023.
- Background: PubMed 24127589Kim CH, Axup JY, Lawson BR, Yun H, Tardif V, Choi SH, Zhou Q, Dubrovska A, Biroc SL, Marsden R, Pinstaff J, Smider VV, Schultz PG. Bispecific small molecule-antibody conjugate targeting prostate cancer. Proc Natl Acad Sci U S A. 2013 Oct 29;110(44):17796-801. doi: 10.1073/pnas.1316026110. Epub 2013 Oct 14.
- Derived from this study: PubMed 34380625Lee SC, Ma JSY, Kim MS, Laborda E, Choi SH, Hampton EN, Yun H, Nunez V, Muldong MT, Wu CN, Ma W, Kulidjian AA, Kane CJ, Klyushnichenko V, Woods AK, Joseph SB, Petrassi M, Wisler J, Li J, Jamieson CAM, Schultz PG, Kim CH, Young TS. A PSMA-targeted bispecific antibody for prostate cancer driven by a small-molecule targeting ligand. Sci Adv. 2021 Aug 11;7(33):eabi8193. doi: 10.1126/sciadv.abi8193. Print 2021 Aug.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CCW702 in people with Metastatic Castration-Resistant Prostate Adenocarcinoma, run by Calibr, a division of Scripps Research at 5 sites in United States.
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 9 inclusion and 6 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 May 2023. 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 United States. 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?
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?
Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities (time frame: up to day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077021, which also lists 2 linked publications.
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 May 2023.