Prostate CancerPhase 1NCT03822871

A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

A Phase 1 study testing CTT1403, CTT1057 and 68Ga-PSMA-11 in people with Prostate Cancer, run by Cancer Targeted Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC). Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: CTT1403, CTT1057 and 68Ga-PSMA-11
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2019to 8 Feb 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients must have histologically confirmed prostate adenocarcinoma that is metastatic and castration resistant (mCRPC).
At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on Screening PSMA PET.
Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the treatment of prostate cancer.
Has progression by the PCWG3 criteria during or after treatment with either abiraterone or enzalutamide
Male Age ≥ 18 years.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).
Demonstrate adequate organ function

Who cannot join

Has received previous treatment with radium-223 or another radiopharmaceutical within 3 months prior to first dose of CTT1403.
Has received prior systemic anti-cancer therapy (excluding radiopharmaceutical) within 14 days, or 5 half-lives, whichever is shorter, prior to first dose of CTT1403.
Has received external-beam radiation within 14 days prior to first dose of CTT1403.
Has received cabazitaxel for the treatment of mCRPC.
Has received previous treatment with a therapeutic targeting PSMA.
Has an additional active malignancy requiring therapy that may confound the assessment of the study endpoints.

Show all 14Show fewer

Has clinically significant cardiovascular disease
Has a history of untreated brain metastases
Has evidence of diffuse bone marrow involvement by prostate cancer in the judgment of study investigator.
Clinically significant urinary obstruction or moderate/severe hydronephrosis on baseline imaging.
Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before CTT1403 administration.
Has known positive status for chronic hepatitis B or hepatitis C
Known or suspected myelodysplastic syndrome.
Has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 9410794143

Other trials in United States

About this study

Official title: A Phase 1 Trial for Evaluation of Safety and 177Lu Radiation Dosimetry of CTT1403: A Peptidomimetic Inhibitor of Prostate Specific Membrane Antigen, in Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

Read the detailed description

This is a Phase 1, first-in-human dose escalation/dose expansion study evaluating escalating doses of CTT1403 in patients with PSMA-avid mCRPC with progressive disease on at least one androgen signaling inhibitor, followed by a dose expansion to further evaluate the safety, tolerability, efficacy and biological activity of CTT1403. CTT1403 is a PSMA-targeted 177Lu-labeled radiotherapy being developed for prostate cancer with a unique PSMA binding scaffold and an albumin binding moiety to extend circulation half-life. The PSMA binding scaffold is shared with CTT1057, a PSMA-specific PET diagnostic imaging agent shown in Phase 1 clinical trials to be specifically taken up by PSMA+ tumor. PSMA PET imaging by CTT1057 will be used diagnostically to select patients with PSMA-avid disease for treatment. The purpose of this study is to identify the dose limiting toxicity and recommended phase 2 dose of CTT1403. Eligible participants with demonstrated therapeutic benefit will be offered a second dose of study drug.

Conditions: Prostate Cancer
Being tested: CTT1403, CTT1057, 68Ga-PSMA-11
Keywords: prostate cancer, metastatic castration resistant prostate cancer, prostate specific membrane antigen, mCRPC, PSMA, positron emission tomography, PET, radiotherapy, targeted therapy, lutetium, 177Lu
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CTT1403Drug
Escalating doses of 0.75 GBq - 9.0 GBq will be administered in an accelerated to traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort. Patients meeting eligibility criteria with demonstrated cessation of disease progression will be offered a second dose of the study drug, CTT1403.
CTT1057Drug
Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.
68Ga-PSMA-11Drug
Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.

Study groups in NCT03822871
Study group	Role	What they receive
Dose Escalation	Experimental	Escalating doses of 0.75 GBq - 2.0 GBq of CTT1403 Receives: Drug: CTT1403; Drug: CTT1057; Drug: 68Ga-PSMA-11
Dose Escalation/Expansion	Experimental	Escalating doses of 3.0 GBq - 9.0 GBq of CTT1403 Receives: Drug: CTT1403; Drug: CTT1057; Drug: 68Ga-PSMA-11

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403
The dose-limiting toxicity was defined as any of the following:
1. Grade 4 neutropenia lasting > 5 consecutive days
2. Grade 3 or 4 febrile neutropenia
3. Grade 4 thrombocytopenia lasting ≥ 7 days, or Grade 3 or 4 thrombocytopenia with clinically significant bleeding or requirement for platelet transfusion
4. Any nonhematologic, treatment-related AE ≥ Grade 3, with the exceptions of Grade 3 nausea, vomiting, diarrhea, non-clinically significant electrolyte abnormality, constipation, fever, fatigue, or skin rash that resolves to Grade ≤ 2 within 72 hours with optimal medical management
5. Any other treatment-related toxicity that results in delay of Cycle 2 administration of CTT1403 by > 21 days and/or toxicity considered by the Investigator and Sponsor's medical representatives to be dose-limiting.
Measured: 6-8 weeks from time of injection on Cycle 1 - Day 1
Objective Response Rate by RECIST v1.1 Criteria
Changes in only the largest diameters (unidimensional measurment) of the tumor lesions are used in the RECIST v1.1 criteria. Data presented as RECIST Overall Response.
Measured: Cycle 1-Day 35, Cycle 2-Day 35, 30 Days After Last Dose, 8 Weeks Post-Treatment. Each cycle lasted 35 days.

Secondary outcomes (3)

Assessment of Organ Dosimetry of CTT1403 by SPECT/CT Imaging
Organ dosimetry was assessed via SPECT/CT imaging until two imaging periods have been collected in which study drug cannot be detected by SPECT/CT. Time points included (2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1. Data calculated using OLINDA. Absorbed dose is calculated as single value wherein absorbed dose is proportional to the integral of activity over time.
Measured: 2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1
Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index
The Brief Pain Index uses a scale of 0-10 to rate the severity of pain. A rating of 0 indicates no pain. A rating of 10 indicates the worst pain imaginable.
Measured: Cycle 1-Day 1 and Cycle 2-Day 1. Each cycle lasted 35 days.
Assessment of Pharmacokinetics of CTT1403
The distribution half-life and the elimination half-life of CTT1403 were calculated.
Measured: Samples were collected during Cycle 1 (timepoints start at the initiation of infusion): Day 1 (30 min +/- 5 min and 2 hrs +/- 30 min), Day 2 (24 hrs +/- 12 hrs), Day 3 (48 hrs +/- 12 hrs), Day 8 (168 hrs +/- 24 hrs), Day 15 (336 hrs +/- 24 hrs)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20198 Feb 2023

First posted30 Jan 2019
Study start1 Apr 2019
Primary completion28 Oct 2022
Study completion8 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate 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: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03822871
Sponsor's protocol ID: CTT1403-101
Other IDs: 5R44CA239461-06
Status last verified: Mar 2024
First submitted: 28 Jan 2019
Last updated: 21 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Trial for Evaluation of Safety and 177Lu Radiation Dosimetry of CTT1403: A Peptidomimetic Inhibitor of Prostate Specific Membrane Antigen, in Metastatic Castration Resistant Prostate Cancer (mCRPC)
ClinicalTrials.gov ID: NCT03822871
Acronym / sponsor ID: CTT1403-101
Conditions: Prostate Cancer
Keywords: prostate cancer, metastatic castration resistant prostate cancer, prostate specific membrane antigen, mCRPC, PSMA, positron emission tomography, PET, radiotherapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Cancer Targeted TechnologyIndustry (pharma, biotech, devices)
Collaborators: University of California, San Francisco, National Cancer Institute (NCI)
Study start: 1 Apr 2019 (actual)
Primary completion: 28 Oct 2022 (actual)
Study completion: 8 Feb 2023 (actual)
First posted: 30 Jan 2019 (actual)
Results: Posted 21 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dose Escalation	Experimental	Drug: CTT1403, Drug: CTT1057, Drug: 68Ga-PSMA-11Escalating doses of 0.75 GBq - 2.0 GBq of CTT1403
Dose Escalation/Expansion	Experimental	Drug: CTT1403, Drug: CTT1057, Drug: 68Ga-PSMA-11Escalating doses of 3.0 GBq - 9.0 GBq of CTT1403

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients must have histologically confirmed prostate adenocarcinoma that is metastatic and castration resistant (mCRPC).
At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on Screening PSMA PET.
Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the treatment of prostate cancer.
Has progression by the PCWG3 criteria during or after treatment with either abiraterone or enzalutamide
Male Age ≥ 18 years.

Key exclusion criteria (14 listed)

Has received previous treatment with radium-223 or another radiopharmaceutical within 3 months prior to first dose of CTT1403.
Has received prior systemic anti-cancer therapy (excluding radiopharmaceutical) within 14 days, or 5 half-lives, whichever is shorter, prior to first dose of CTT1403.
Has received external-beam radiation within 14 days prior to first dose of CTT1403.
Has received cabazitaxel for the treatment of mCRPC.
Has received previous treatment with a therapeutic targeting PSMA.

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
CTT1403Escalating doses of 0.75 GBq - 9.0 GBq will be administered in an accelerated to traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort. Patients meeting eligibility criteria with demonstrated cessation of disease progression will be offered a second dose of the study drug, CTT1403.	Drug	Dose Escalation, Dose Escalation/Expansion
CTT1057Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.	Drug	Dose Escalation, Dose Escalation/Expansion
68Ga-PSMA-11Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.	Drug	Dose Escalation, Dose Escalation/Expansion

Primary outcome

Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403
Time frame: 6-8 weeks from time of injection on Cycle 1 - Day 1
The dose-limiting toxicity was defined as any of the following: 1. Grade 4 neutropenia lasting > 5 consecutive days 2. Grade 3 or 4 febrile neutropenia 3. Grade 4 thrombocytopenia lasting ≥ 7 days, or Grade 3 or 4 thrombocytopenia with clinically significant bleeding or requirement for platelet transfusion 4. Any nonhematologic, treatment-related AE ≥ Grade 3, with the exceptions of Grade 3 nausea, vomiting, diarrhea, non-clinically significant electrolyte abnormality, constipation, fever, fatigue, or skin rash that resolves to Grade ≤ 2 within 72 hours with optimal medical management 5. Any other treatment-related toxicity that results in delay of Cycle 2 administration of CTT1403 by > 21 days and/or toxicity considered by the Investigator and Sponsor's medical representatives to be dose-limiting.
Objective Response Rate by RECIST v1.1 Criteria
Time frame: Cycle 1-Day 35, Cycle 2-Day 35, 30 Days After Last Dose, 8 Weeks Post-Treatment. Each cycle lasted 35 days.
Changes in only the largest diameters (unidimensional measurment) of the tumor lesions are used in the RECIST v1.1 criteria. Data presented as RECIST Overall Response.

3 secondary outcomes

Assessment of Organ Dosimetry of CTT1403 by SPECT/CT Imaging
Time frame: 2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1
Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index
Time frame: Cycle 1-Day 1 and Cycle 2-Day 1. Each cycle lasted 35 days.
Assessment of Pharmacokinetics of CTT1403
Time frame: Samples were collected during Cycle 1 (timepoints start at the initiation of infusion): Day 1 (30 min +/- 5 min and 2 hrs +/- 30 min), Day 2 (24 hrs +/- 12 hrs), Day 3 (48 hrs +/- 12 hrs), Day 8 (168 hrs +/- 24 hrs), Day 15 (336 hrs +/- 24 hrs)

Results and safety

Results posted to the registry on 21 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.75 GBq Cohort	1	1
1.5 GBq Cohort	1	1
2.0 GBq Cohort	1	1
3.0 GBq Cohort	3	3
4.5 GBq Cohort	4	4
6.0 GBq Cohort	3	3
7.5 GBq Cohort	3	3
9.0 GBq Cohort	1	1

Primary outcome: Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403

Time frame: 6-8 weeks from time of injection on Cycle 1 - Day 1. Count of participants. Unit: Participants

Measure	0.75 GBq Cohort n = 1	1.5 GBq Cohort n = 1	2.0 GBq Cohort n = 1	3.0 GBq Cohort n = 3	4.5 GBq Cohort n = 4	6.0 GBq Cohort n = 3	7.5 GBq Cohort n = 3	9.0 GBq Cohort n = 1
Number of participants who experienced a dose-limiting toxicity	0	0	0	0	0	0	0	0
Number of participants who did not experience a dose-limiting toxicity	1	1	1	3	4	3	3	1

Primary outcome: Objective Response Rate by RECIST v1.1 Criteria

Time frame: Cycle 1-Day 35, Cycle 2-Day 35, 30 Days After Last Dose, 8 Weeks Post-Treatment. Each cycle lasted 35 days.. Count of participants. Unit: Participants

Measure	1.5 GBq Cohort n = 1	2.0 GBq Cohort n = 1	3.0 GBq Cohort n = 3	4.5 GBq Cohort n = 4	6.0 GBq Cohort n = 3	7.5 GBq Cohort n = 3	9.0 GBq Cohort n = 1
Number of patients with stable disease on Cycle 1-Day 35	1	0	1	4	2	1	1
Number of patients with progressive disease on Cycle 1-Day 35	0	1	2	0	1	1	0
Number of patients with stable disease on Cycle 2-Day 35	1	0	0	2	1	3	0
Number of patients with progressive disease on Cycle 2-Day 35	0	0	1	0	1	0	1
Number of patients with stable disease 30 days after last dose	0	0	0	0	0	0	0
Number of patients with progressive disease 30 days after last dose	0	1	1	0	0	0	0
Number of patients with stable disease 8 weeks post-treatment	0	0	0	0	0	0	0
Number of patients with progressive disease 8 weeks post-treatment	0	0	0	1	1	1	0

Population analysed: In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.75 GBq Cohort	0 of 1 (0%)	1 of 1 (100%)	1 of 1
1.5 GBq Cohort	0 of 1 (0%)	1 of 1 (100%)	1 of 1
2.0 GBq Cohort	0 of 1 (0%)	0 of 1 (0%)	1 of 1
3.0 GBq Cohort	0 of 3 (0%)	2 of 3 (66.7%)	3 of 3
4.5 GBq Cohort	1 of 4 (25%)	2 of 4 (50%)	4 of 4
6.0 GBq Cohort	1 of 3 (33.3%)	2 of 3 (66.7%)	3 of 3
7.5 GBq Cohort	1 of 3 (33.3%)	1 of 3 (33.3%)	3 of 3
9.0 GBq Cohort	0 of 1 (0%)	1 of 1 (100%)	1 of 1

Limitations and caveats (from the sponsor): The highest administered dose of CTT1403 was 9.0 GBq. At the 9.0 GBq dose, patients had to remain in-patient (in hospital) after administration due to continued radioactivity and for the safety of others until radioactivity dropped to an acceptable level as deemed by the hospital radiation safety committee.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Beatrice Langton-Webster, PhD study chair

Cancer Targeted Technology

Rahul Aggarwal, MD principal investigator

University of California, San Francisco

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 CTT1403, CTT1057 and 68Ga-PSMA-11 in people with Prostate Cancer, run by Cancer Targeted Technology at 1 site 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 21 Mar 2024. 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 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?

Yes. Results are posted in the registry (first posted 21 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403 (time frame: 6-8 weeks from time of injection on Cycle 1 - Day 1). 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?

On the ClinicalTrials.gov record for NCT03822871.

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 21 Mar 2024.