Castration-Resistant Prostate CancerPhase 1NCT03569280
Evaluation of Safety and Efficacy of KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide in CRPC Patients
A Phase 1 study testing Enzalutamide or Abiraterone or Apalutamid in people with Castration-Resistant Prostate Cancer, run by Kangpu Biopharmaceuticals, Ltd. at 3 sites in United States.
Trial summary
This is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles to adult subjects. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-Resistant Prostate Cancer
- What is being tested?
- Enzalutamide or Abiraterone or Apalutamid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Nov 2019to 15 Jun 2023
- 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
- Signed informed consent provided prior to any study-related procedure being performed;
- Able to swallow and retain orally administered medication;
- Male aged 18 years and older;
- diagnosis of prostate carcinoma;
- Men with either non-metastatic or metastatic CRPC are eligible;
- Completed at least 4 or more weeks of prior continuous therapy with fixed stable dose enzalutamide, abiraterone or apalutamide prior to initiating study treatment (for Part 1), or with fixed stable dose enzalutamide (for Part 2), with no change in dose for at least 2 weeks prior to screening;
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- Serum testosterone level <50 ng/dL (<0.5 ng/mL, <7.0 nmol/L).
- ECOG performance status of 0 or 1;
- Adequate baseline organ function;
- Must have a QT interval corrected for heart rate according to Fridericia's formula (QTcF) <470 milliseconds (msec) or <480 msec with bundle branch block;
- Male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of screening until 3 months after the last dose of study medication;
- Willing and able to comply with all protocol required visits and assessments.
Who cannot join
- Prior chemotherapy, radiation;
- Prior malignancy other than CRPC.
- Uncontrolled hypothyroidism, or TSH >2.0 x ULN at screening.
- Current use of or anticipated requirement of prohibited medication(s);
- Any unresolved ≥grade 2 (per CTCAE v5.0) toxicity from previous anti-cancer therapy;
- Previous history of difficulty swallowing capsules;
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- Known active infection requiring intravenous (IV);
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test ;
- History of seizure or any condition that may predispose subject to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months prior to the start of study medication;
- Poorly controlled hypertension;
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
- History or evidence of cardiovascular risk; known cardiac metastases;
- Previous major surgery within 30 days prior to the start of study medication;
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
About this study
Official title: A First-in-Human Study to Determine the Safety, Pharmacokinetics and Efficacy of KPG-121 When Administered With Enzalutamide, Abiraterone, or Apalutamide in Subjects With Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
This is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles to adult subjects.
Read the detailed description
This Phase 1 study will comprise two parts: Part 1 will be a 3+3 dose escalation design to characterize the MTD and a RP2D, Part 2 will be an expansion cohort at RP2D.
- Conditions
- Castration-Resistant Prostate Cancer
- Being tested
- Enzalutamide or Abiraterone or Apalutamid
- Keywords
- KPG-121, Enzalutamide, Abiraterone, Apalutamide, Non-metastatic and Metastatic Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide or Abiraterone or ApalutamidCombination product
Antitumor treatment
| Study group | Role | What they receive |
|---|---|---|
| KPG-121 | Experimental | Safety and Antitumor Activity of KPG-121 capsules at different dose level for 21 days Receives: Combination Product: Enzalutamide or Abiraterone or Apalutamid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121
MTD is one dose level below the dose level that results in ≥33% of subjects with a DLT
Measured: Cycle-1 (28-day)
Secondary outcomes (2)
Incidence of Adverse Events [Safety and Tolerability]
Treatment-Emergent Adverse events
Measured: Up to Cycle-6 (28-day per cycle)
Pharmacokinetic (PK) profile of KPG-121
Plasma concentrations of KPG-121
Measured: Cycle-1 (up to 28-day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start26 Nov 2019
- Primary completion10 Jan 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-Resistant 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
- Not applicable
- Intervention model
- Sequential
- Model description
- KPG-121 Plus Enzalutamide or Abiraterone or Apalutamid
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangpu Biopharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yao Wang, Study director, Kangpu Biopharmaceuticals, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569280
- Sponsor's protocol ID
- KPG-121-101
- Status last verified
- Jul 2023
- First submitted
- 22 May 2018
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study to Determine the Safety, Pharmacokinetics and Efficacy of KPG-121 When Administered With Enzalutamide, Abiraterone, or Apalutamide in Subjects With Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03569280
- Acronym / sponsor ID
- KPG-121-101
- Conditions
- Castration-Resistant Prostate Cancer
- Keywords
- KPG-121, Enzalutamide, Abiraterone, Apalutamide, Non-metastatic and Metastatic Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kangpu Biopharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 26 Jun 2018 (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 is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles to adult subjects.
Detailed description
This Phase 1 study will comprise two parts: Part 1 will be a 3+3 dose escalation design to characterize the MTD and a RP2D, Part 2 will be an expansion cohort at RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- KPG-121 Plus Enzalutamide or Abiraterone or Apalutamid
| Arm | Type | Receives |
|---|---|---|
| KPG-121 | Experimental | Combination Product: Enzalutamide or Abiraterone or ApalutamidSafety and Antitumor Activity of KPG-121 capsules at different dose level for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent provided prior to any study-related procedure being performed;
- Able to swallow and retain orally administered medication;
- Male aged 18 years and older;
- diagnosis of prostate carcinoma;
- Men with either non-metastatic or metastatic CRPC are eligible;
Key exclusion criteria (13 listed)
- Prior chemotherapy, radiation;
- Prior malignancy other than CRPC.
- Uncontrolled hypothyroidism, or TSH >2.0 x ULN at screening.
- Current use of or anticipated requirement of prohibited medication(s);
- Any unresolved ≥grade 2 (per CTCAE v5.0) toxicity from previous anti-cancer therapy;
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 |
|---|---|---|
| Enzalutamide or Abiraterone or ApalutamidAntitumor treatment | Combination product | KPG-121 |
Primary outcome
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121
Time frame: Cycle-1 (28-day)
MTD is one dose level below the dose level that results in ≥33% of subjects with a DLT
2 secondary outcomes
Incidence of Adverse Events [Safety and Tolerability]
Time frame: Up to Cycle-6 (28-day per cycle)
Pharmacokinetic (PK) profile of KPG-121
Time frame: Cycle-1 (up to 28-day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- 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.
Yao Wang study director
Kangpu Biopharmaceuticals, Ltd.
3 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 Enzalutamide or Abiraterone or Apalutamid in people with Castration-Resistant Prostate Cancer, run by Kangpu Biopharmaceuticals, Ltd. at 3 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 12 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: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121 (time frame: Cycle-1 (28-day)). 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 18 Jul 2023.