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Prostate CancerPhase 1NCT05973149

Trial of QLH12016 in Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 1 study testing QLH12016 in people with Prostate Cancer, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the tolerance, safety, pharmacokinetics, and preliminary anti-tumor activity of QLH12016 in 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
Prostate Cancer
What is being tested?
QLH12016
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
2 sitesChina
Study dates
31 Aug 2023to 1 Jan 2026
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

  • Voluntarily participate and sign a written informed consent form
  • Male, aged ≥ 18 years
  • ECOG：0-1
  • Expected survival time of at least 3 months
  • Prostate adenocarcinoma confirmed by histological or cytological without neuroendocrine or small cell characters
  • Continuous treatment with luteinizing hormone releasing hormone analogue or luteinizing hormone releasing hormone antagonist (drug castration), or previous bilateral orchiectomy (surgical castration); Subjects who did not receive bilateral orchiectomy must plan to maintain effective luteinizing hormone releasing hormone analog or luteinizing hormone releasing hormone antagonist treatment throughout the study period
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  • testosterone≤50 ng/dL or 1.7 nmol/L
  • CRPC is defined as the occurrence of one or more of the following three events in a subject while undergoing castration treatment: ① PSA progression, defined as at least two increases in PSA levels (PSA value>1 ng/mL, interval of at least 1 week, consecutive 2 times, increase>50% from baseline); ② Disease progression as defined in RECIST v1.1; ③ The progression of skeletal diseases as defined by the PCWG3 standard, where bone scans reveal ≥ 2 or more new lesions
  • Metastatic lesion with imaging evidence. At least one target lesion exists
  • Received 1-2 lines of new endocrine therapy (such as enzalutamide, abiolone, etc.) after developing castration resistance（ArmA-C）
  • Received 0-1 line chemotherapy treatment (such as docetaxel) during the hormone sensitive period and the castration resistance period（ArmA-C）
  • Arm B: with specific biomarkers; Arm C: without specific biomarkers; Arm D: received 0 or 1 line of new endocrine therapy, and no chemotherapy during hormone sensitive and castration resistant stages
  • The functional level of important organs must meet the following requirements (no blood components, hematopoietic stimulating factors, cell growth factors, leukemic drugs, platelet enhancing drugs, etc. are allowed to be used within 7 days before obtaining laboratory examination): Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 100 g/L; Serum albumin ≥ 30 g/L; AST and ALT ≤ 2.5 × Upper limit of normal reference value (ULN), if accompanied by liver metastasis, ALT and AST ≤ 5 × ULN; Total bilirubin ≤ 1.5 × ULN (Gilbert syndrome≤ 3 × ULN); Serum creatinine ≤ 1.5 × ULN, if >1.5 × ULN, then the creatinine clearance rate (CLcr) ≥ 50 mL/min; LVEF>50%
  • Effective contraceptive measures from signing the informed consent to 90 days after the last use of the study drug
  • Recover from all AEs of previous anti-cancer treatment (i.e. ≤ grade 1, according to CTCAE v5.0), excluding alopecia (any grade) and peripheral sensory nerve ≤ grade 2, hypomagnesemia or lymphocytopenia, as well as other abnormalities that the benefit of receiving treatment is greater than the risk

Who cannot join

  • Metastasis of the central nervous system (CNS), leptomeningeal metastasis or spinal cord compression caused by metastasis (exceeding the physiological alternative dose) requiring hormone treatment
  • Radiation therapy that has irradiated more than 25% of the bone marrow was performed within 4 weeks. Palliative radiation therapy is allowed to alleviate pain caused by bone metastasis during the study period
  • Treatment with similar drugs
  • Received other clinical trial drugs or major surgeries within 4 weeks (sufficient wound healing after major surgeries must undergo clinical evaluation)
  • Systemic anti-cancer treatment within the first 2 weeks (bicalutamide, Mitomycin C or Nitroso urea 6 weeks, enzalutamide 5 weeks, and abiolone 4 weeks). Medications that maintain castration are allowed.
  • Planned bilateral orchiectomy during the study treatment
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  • Inability to swallow, chronic diarrhea and bowel obstruction, or other factors affecting drug administration and absorption
  • Epilepsy or disease that can induce seizure within 12 months (including a history of transient ischemic attack, stroke, brain trauma with disorders of consciousness, etc.)
  • History of psychotropic substance abuse, alcoholism, or drug use, neurological or mental disorders, including dementia or hepatic encephalopathy
  • Any of the following conditions occurs within 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure (New York Heart Association III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism or other thromboembolic diseases with clinical significance
  • Any of the following conditions within 6 months: congenital long QT syndrome, torsade de pointes ventricular tachycardia, arrhythmia (including persistent ventricular tachyarrhythmia and Ventricular fibrillation), left anterior half block (double vessel block) or persistent arrhythmia above NCI-CTCAE grade 2, Atrial fibrillation of any level (in the case of Asymptomatic isolated Atrial fibrillation, grade ≥ 2)
  • Cardiovascular diseases under poor control, including angina pectoris, pulmonary hypertension or serious cardiac rhythm or conduction abnormalities
  • QTcF>450 ms
  • Active, uncontrolled bacterial, fungal, or viral infections, including but not limited to: 1) Active hepatitis B virus (HBV), hepatitis C virus (HCV) infected persons (hepatitis B surface antigen [HBsAg] positive or hepatitis B core antibody [HBcAb] positive, HBV DNA virus copy number ≥ 500 IU/mL, HCV antibody positive and HCV RNA higher than the detection limit of the analysis method); 2) Syphilis required treatment; 3) History of congenital immunodeficiency or organ transplantation, or HIV (HIV) positive
  • Clinically uncontrollable third space effusion, such as pleural effusion, peritoneal effusion, pericardial effusion, etc. that cannot be controlled by drainage or other measures and cannot be included in the group according to the judgment of the investigator
  • Other malignant tumors within 5 years (excluding cured basal cell skin cancer, papillary thyroid cancer, etc.)
  • Concomitant diseases seriously endangering the safety of the subject or affect the completion of the study, such as hypertension (systolic pressure ≥ 160 mmHg and/or diastolic pressure ≥ 100 mmHg) that cannot be controlled by two or more antihypertensive drugs, diabetes not well controlled, etc
  • History of hypertensive crisis or hypertensive encephalopathy
  • Allergy to any study drug component
  • Gastrointestinal perforation, gastrointestinal or non gastrointestinal fistula, or abdominal abscess within 6 months
  • Any life-threatening bleeding event within 3 months, including the need for blood transfusion treatment, surgery or local treatment, and continuous medication treatment
  • Subjects who may increase research related risks, interfere with the interpretation of research results, or are deemed unsuitable for inclusion by the researcher

Trial locations and contacts

2 sites in 1 country.

Zhisong He, Phd contact

8613910688432

wyj7074@sohu.com

China2 sites

  • Department of Urology, Peking University First Hospital

    Beijing, Beijign, 100034

    Zhisong He, Phd, 8613910688432, wyj7074@sohu.com

  • Department of Urology, Drum Tower Hospital, Nanjing University School of Medicine

    Nanjing, Jiangsu, 210008

    Hongqian Guo, Phd, 8613605171690, dr.ghq@nju.edu.cn

Other trials in China

About this study

Official title: Tolerance, Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLH12016 in Patients With Metastatic Castration Resistant Prostate Cancer

To evaluate the tolerance, safety, pharmacokinetics, and preliminary anti-tumor activity of QLH12016 in patients with metastatic castration resistant prostate cancer

Read the detailed description

Subjects will use QLH12016 for the treatment of mCRPC.

Conditions
Prostate Cancer
Being tested
QLH12016
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • QLH12016Drug

    according to the scheme description

Study groups in NCT05973149
Study groupRoleWhat they receive
QLH12016 dose escalationExperimentalDaily dosages are predetermined by Safety Monitoring Committee after the initial starting dose cohort at the end of Cycle 1 (each cycle is 28 days)
Receives: Drug: QLH12016
QLH12016 in mCRPC with specific biomarkersExperimentalDaily dosage and schedule at a recommended Phase 2 dose based on data from Arm A
Receives: Drug: QLH12016
QLH12016 in mCRPC without specific biomarkersExperimentalDaily dosage and schedule at a recommended Phase 2 dose based on data from Arm A
Receives: Drug: QLH12016
QLH12016 in less pretreated mCRPCExperimentalDaily dosage and schedule at a recommended Phase 2 dose based on data from Arm A
Receives: Drug: QLH12016

What is being measured

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

  1. Arm A： Incidence of Dose Limiting Toxicities

    First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug

    Measured: 28 Days

  2. Arm A：Maximum Tolerated Dose

    The Maximum Tolerated Dose determined by the Incidence of Dose Limiting Toxicities

    Measured: 28 Days

  3. Arm A：Recommended Phase 2 Dose

    Recommended Phase 2 Dose determined by the frequency of Incidence of Dose Limiting Toxicities

    Measured: 28 Days

  4. Arm A：AE

    The incidence, severity and correlation with the study drug of adverse events (AEs) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0

    Measured: 20 weeks

  5. Arm A：SAE

    The incidence, severity and correlation with the study drug of Serious adverse event (SAE) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0

    Measured: 20 weeks

  6. Arm B-D：PSA Response Rate

    a decrease of ≥ 50% in PSA levels from baseline to baseline, and reassessed PSA relief after ≥ 3 weeks in each arm

    Measured: 20 weeks

  7. Arm B-D：Objective Response Rate

    the percentage of "CR/PR" subjects in each arm

    Measured: 20 weeks

Secondary outcomes (11)

  1. Cmax

    The highest plasma drug concentration

    Measured: 20 weeks

  2. Tmax

    The time blood drug concentration reaching Cmax

    Measured: 20 weeks

  3. AUC

    The area enclosed by the drug time curve and the time axis

    Measured: 20 weeks

  4. Arm A：ORR

    the percentage of "CR/PR" subjects

    Measured: 20 weeks

  5. Arm A：PSA Response Rate

    a decrease of ≥ 50% in PSA levels from baseline to baseline, and reassessed PSA relief after ≥ 3 weeks

    Measured: 20 weeks

  6. Arm B-D：AE

    The incidence, severity and correlation with the study drug of adverse events (AEs) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0

    Measured: 20 weeks

  7. Arm B-D：SAE

    The incidence, severity and correlation with the study drug of Serious adverse event (SAE) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0

    Measured: 20 weeks

  8. DOR

    The time between the initial evaluation of CR or PR and disease progression

    Measured: 20 weeks

  9. DCR

    the percentage of "CR/PR/SD" subjects

    Measured: 20 weeks

  10. rPFS

    The time between the first administration of the investigational drug and the first recording of disease progression (determined according to RECIST v1.1 and PCWG3) or the date of all-cause death (whichever occurs first)

    Measured: 20 weeks

  11. OS

    The time between the first trial drug administration and patient death due to various reasons

    Measured: 20 weeks

Timeline

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

  1. First posted2 Aug 2023
  2. Study start31 Aug 2023 (estimated)
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05973149
Sponsor's protocol ID
QLH12016-101
Status last verified
Jul 2023
First submitted
17 Jul 2023
Last updated
2 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing QLH12016 in people with Prostate Cancer, run by Qilu Pharmaceutical Co., Ltd. at 2 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 15 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhisong He, Phd (8613910688432, wyj7074@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm A： Incidence of Dose Limiting Toxicities (time frame: 28 Days). The study lists 7 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 NCT05973149.

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 2 Aug 2023.

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