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Metastatic Castration-resistant Prostate CancerPhase 1/2NCT05405439

To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

A Phase 1/2 study testing TQB3823 tablets, Abiraterone acetate tablets and prednisone acetate tablets in people with Metastatic Castration-resistant Prostate Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 23 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase Ib/II clinical study to explore the safety and efficacy of TQB3823 tablets combined with abiraterone acetate tablets and prednisone acetate tablets in patients with metastatic castration-resistant prostate cancer. Read more about this study

Who is it for?
Ages 18 to 85 years, men only
What is being tested?
TQB3823 tablets, Abiraterone acetate tablets and prednisone acetate tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
23 sitesChina
Study dates
25 Aug 2022to 19 Jul 2023
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 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male patients aged 18 to 85.
  • Subjects with pathologically proven with prostate adenocarcinoma.
  • Metastatic disease confirmed by imaging (eg, bone scan and CT/MRI).
  • The patient's serum testosterone level at the screening visit was ≤ 1.73 nmol/L (50 ng/dL). Patients who did not undergo bilateral orchiectomy required continued ADT [gonadotropin-releasing hormone analog (LHRHa, agonist/antagonist)] treatment throughout the study period.
  • Disease progression during consecutive androgen deprivation therapy (ADT), defined at study entry, as meeting one or more of the following criteria:
  • At least two consecutive PSA elevations separated by at least 1 week, the last result must be at least 1.0 ng/mL.
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  • Soft tissue lesion progression as assessed by RECIST 1.1 with or without PSA progression.
  • Bone disease progression assessed by PCWG3, i.e., ≥2 new lesions detected on bone scan, ≥2 new bone lesions other than those previously assessed on reassessment at least 8 weeks later, with ≥2 previously assessed bone lesions still exist, regardless of PSA progression.
  • Patients must discontinue all prior cancer therapy (except ADT and bone loss prophylaxis) and have recovered to ≤ Grade 1 or baseline (according to the Common Terminology Criteria for Adverse Events) prior to first dose of all acute toxic effects of prior therapy or surgery Version 5.0 [CTCAE v 5.0]), with the exception of alopecia and peripheral neuropathy, and the washout period since the last prior systemic or radiation therapy was as follows:
  • At least 4 weeks must have elapsed since enrollment with 5-alpha reductase inhibitors (eg, dutasteride, finasteride), estrogen, and cyproterone.
  • At least 4 weeks must have elapsed from major surgery or radiation therapy to enrollment。
  • Laboratory indicators meet the requirements.

Who cannot join

  • For subjects with brain metastases with symptoms or symptom control for less than 1 month, screening for CNS metastases at baseline is not required unless there are signs and/or symptoms of CNS involvement.
  • Subjects who have developed or is currently suffering from other malignancies within 3 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
  • Subjects who have accepted botanicals (such as saw palmetto) that may lower PSA levels within 4 weeks before the first dose.
  • Subjects who have accepted oral targeted drugs within 5 drug half-lives from the first dose (calculated from the end of the last treatment).
  • Subjects who have not recovered to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to the adverse event of prior therapy.
  • Subjects who have previously accepted CYP17 enzyme inhibitors (including drugs such as abiraterone, TAK-700, TOK-001, and ketoconazole, ect.,) or second generation androgen receptor inhibitors (including enzalutamide, apalutamide, darolutamide , etc.) (mHSPC, nmCRPC stage).
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  • The study accept patients who received McRpc-based chemotherapy with CYP17 inhibitors other than abiraterone or second-generation androgen receptor inhibitors or paclitaxel for less than 3 months without disease progression, However, 4 weeks or 5 half-life washing out period is required (whichever is longer).
  • Patients who received abiraterone in the mCRPC phase for less than 3 months and did not progress (no need to stop elution) are allowed in the study, but cannot be enrolled in the phase I cohort of a single drug population in this study.
  • Patients who received ADT+ paclitaxel chemotherapy, ADT+ 1st generation androgen receptor inhibitors (e.g. Flutamide, bicalutamide, nilutamide, etc.), ADT+ERBT (external radiation therapy) in mHSPC phase will be acceptable in the study, provided that they met the exclusion criteria 2.
  • Subjects who receive medications known to be potent inhibitors of cytochrome P450 3A4 (CYP3A4) or potent or moderate inducers and unable to discontinue these medications or switch to another for at least 5 half-lives prior to initiation of study medication different medicines.
  • Subjects who suffer from contraindications to prednisone (corticosteroid) use, such as active systemic infection (e.g. bacterial infection requiring intravenous antibiotics at initiation of study treatment, fungal infection, or detectable viral infection requiring systemic therapy ) or viral load (e.g. known HIV positive or known active hepatitis B or C (e.g. hepatitis B surface antigen positive). Screening for contraindications other than HIV/HBV and HCV is not required to determine eligibility.
  • Subjects with history of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest CT scan during screening.
  • Subjects with any chronic condition requiring corticosteroid treatment at doses greater than "Prednisone 5mg, BID";

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • The First Hospital of Peking University

    Beijing, Beijing Municipality, 100034

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • West China Hospital，Sichuan University

    Chengdu, Sichuan, 610000

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • The Southwest Hospitai of Amu

    Chongqing, Chongqing Municipality, 400083

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 401147

  • Sun Yat-Sun University Cancer Prevertion and Treatment Center

    Guangzhou, Guangdong, 510060

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101

  • The Second Hospital of Harbin Medical University

    Lanzhou, Gansu, 730030

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621099

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210003

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Qingyuan People's Hospital

    Qingyuan, Guangdong, 510000

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200336

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, 110004

  • Cancer Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Wenzhou Medical Univerity

    Wenzhou, Zhejiang, 325000

  • The First Affiliated Hospital of The Chinese People's Liberation Army Air Force Military Medical University

    Xi’an, Shanxi, 710032

  • Zigong Fourth People's Hospital

    Zigong, Sichuan, 643000

Other trials in China

About this study

Official title: Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

This is a phase Ib/II clinical study to explore the safety and efficacy of TQB3823 tablets combined with abiraterone acetate tablets and prednisone acetate tablets in patients with metastatic castration-resistant prostate cancer.

Read the detailed description

This is a two-phase, open-label Phase Ib clinical trial. The first phase plans to enroll 6-12 patients as two cohorts to explore the safety and of TQB3823 tablets combined with abiraterone and prednisone and the recommended dose of phase II of TQB3823. Subjects involved in cohort one accepts TQB3823 treatment during cycle one and then TQB3823 combined with abiraterone and prednisone from cycle two till the disease progression. The second phase plans to enroll a total of 40-60 subjects, aiming to evaluate the safety and efficacy of TQB3823 tablets combined with abiraterone and prednisone.

Being tested
TQB3823 tablets, Abiraterone acetate tablets, prednisone acetate tablets

What participants receive

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

  • TQB3823 tabletsDrug

    TQB3823 tablet is an inhibitor of poly ADP-ribose polymerase (PARP).

  • Abiraterone acetate tabletsDrug

    Abiraterone acetate tablet is an inhibitor of cytochrome P450 17（CYP17）

  • prednisone acetate tabletsDrug

    Prednisone acetate tablet is a kind of glucocorticoids

Study groups in NCT05405439
Study groupRoleWhat they receive
TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tabletsExperimentalTQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets，28 days as a treatment cycle.
Receives: Drug: TQB3823 tablets; Drug: Abiraterone acetate tablets; Drug: prednisone acetate tablets

What is being measured

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

  1. Dose limiting toxicity (DLT)

    The relevant adverse reactions occurred within the first cycle

    Measured: Up to 4 weeks

  2. Recommended phase II dose (RP2D)

    The dose of TQB3823 tablet which is recommended to use during phase II clinical trial

    Measured: Up to 8 weeks

  3. The ratio of subject radiographic progression-free survival for 12 months

    Proportion of subjects without disease progression assessed by radiology within 12 months

    Measured: For 12 months

  4. Adiographic progression-free survival (rPFS)

    rPFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause evaluated by radiological examination

    Measured: Up to 24 months

Secondary outcomes (13)

  1. The ratio of subject radiographic progression-free survival for 12 months

    Proportion of subjects without disease progression assessed by radiology within 6 months

    Measured: For 6 months

  2. The ratio of prostate specific antigen (PSA) reduction

    Proportion of subjects with reduction of PSA

    Measured: Up to 24 months

  3. Overall response rate (ORR) based on 2014 Lugano

    Percentage of participants achieving complete response (CR) and partial response (PR).

    Measured: Up to 24 months

  4. Overall survival (OS)

    OS defined as the time from randomization until the death from any cause

    Measured: Up to death

  5. Clinical benefit rate (CBR)

    Proportion of subjects with clinical benefit

    Measured: Up to 24 months

  6. Duration of Response (DOR)

    The time when the participants first achieved CR or PR to disease progression or death from any cause.

    Measured: Up to 24 months

  7. time to bone-related event

    Time to progression of bone disease in subjects

    Measured: Up to 24 months

  8. Time to PSA progression

    Time to raise of PSA in subjects

    Measured: Up to 24 months

  9. Peak time (Tmax)

    The time to peak concentration

    Measured: Cycle 1 day 1 and cycle 1 day 28 Before administration, and 1, 2, 4, 6, 8, 11, 12, 24 hours after administration. Cycle 1 day 14 before administration,(each cycle is 28 days)

  10. Peak concentration (Cmax)

    Maximum plasma drug concentration

    Measured: Cycle 1 day 1 and cycle 1 day 28 Before administration, and 1, 2, 4, 6, 8, 11, 12, 24 hours after administration. Cycle 1 day 14 before administration,(each cycle is 28 days)

  11. Half-life /T1/2

    The time it takes for the drug's concentration in the body to drop by half

    Measured: Cycle 1 day 1 and cycle 1 day 28 Before administration, and 1, 2, 4, 6, 8, 11, 12, 24 hours after administration. Cycle 1 day 14 before administration,(each cycle is 28 days)

  12. Adverse event rate

    The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

    Measured: Baseline up to 96 weeks

  13. Adverse event rate

    The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

    Measured: Baseline up to 24 months

Timeline

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

  1. First posted6 Jun 2022
  2. Study start25 Aug 2022
  3. Primary completion19 Jul 2023
  4. Study completion19 Jul 2023

Why it stopped: The sponsor voluntarily terminated the study

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05405439
Sponsor's protocol ID
TQB3823-Ib/II-01
Status last verified
Nov 2023
First submitted
24 May 2022
Last updated
3 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQB3823 tablets, Abiraterone acetate tablets and prednisone acetate tablets in people with Metastatic Castration-resistant Prostate Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 23 sites in China.

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: stopped early, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. 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: The sponsor voluntarily terminated the study). 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?

Dose limiting toxicity (DLT) (time frame: Up to 4 weeks). The study lists 4 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 NCT05405439.

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 3 Nov 2023.

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