AzTrials
AzTrials

Advanced Malignant Solid TumorsPhase 1/2NCT05478785

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of Cisplatin Micelle Injection (HA132) in Patients With Advanced Malignant Solid Tumors

A Phase 1/2 study testing Cisplatin micelle injection (HA132) in people with Advanced Malignant Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This is a multicenter, open-label, dose-escalation, dose-expansion, and cohort-expansion Phase I/II clinical study to evaluate safety, tolerability, pharmacokinetics, antitumor efficacy and to determine the maximum tolerated dose (MTD) and recommended Phase 2 doses (RP2D) of cisplatin micelle injection in patients… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
Cisplatin micelle injection (HA132)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteChina
Study dates
Aug 2022to Aug 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 70 years (inclusive), no gender limitation;
  • Stage I: patients with advanced, recurrent or metastatic solid tumors confirmed by histology or cytology, and no standard treatment, or ineffective or intolerable to standard treatment, or those who are not eligible to receive standard treatment; Stage II: Pending;
  • Have at least one measurable lesion according to RECIST v1.1;
  • Eastern Cooperative Oncology Group (ECOG) physical performance status score of 0-1;
  • Life expectancy of at least 3 months;
  • Major organ function within 7 days prior to treatment, meeting the following criteria (have not received blood transfusion, EPO, G-CSF or other medical supportive treatment within 14 days before study drug administration):
Show all 19Show fewer
  • Blood routine:
  • Neutrophil absolute value (ANC) ≥ 1.5 × 10^9/L;
  • Platelet (PLT) ≥ 90× 10^9/L;
  • Hemoglobin (HB) ≥ 90 g/L;
  • Renal function:
  • Creatinine (Cr) ≤ 1.5 × ULN;
  • Creatinine clearance (CrcL) ≥ 60 mL/min (Using the Cockcroft-Gault formula);
  • Liver function:
  • Total bilirubin (TBIL) ≤ 1.5 × ULN;
  • Aspartate amino transferase( AST) and Alanine amino transferase (ALT) 2.5 × ULN, or ≤ 5 × ULN in patients with hepatic metastasis or primary liver cancer;
  • Alkaline phosphatase (ALP) ≤ 2.5 ×ULN, or ≤ 5 × ULN in patients with hepatic metastasis or primary liver cancer;
  • Women of childbearing age should agree that contraceptive measures (such as intrauterine device or condoms) must be used within study period and within 6 months after the end of the study; the serum or urine pregnancy tests is negative within 7days prior to the study for non-lactating patients; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
  • Patients must give informed consent to this study before the trial, and voluntarily sign the written informed consent.

Who cannot join

  • The patient has received chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatments or participated in other clinical trials within 4 weeks before the first use of the study drug, or within 5 half-lives of the treatment drug, whichever is longer;
  • The patient has received platinum-based therapy within 3 months prior to the study drug;
  • The patient has undergone major organ surgery (excluding needle biopsy) or suffered significant trauma within 4 weeks before the first use of the study drug;
  • The patient has received nephrotoxic or ototoxic drugs such as cephalosporin, aminoglycoside antibiotics, amphotericin B within 14 days before the first use of the study drug;
  • Those who are allergic to any excipients of the study drug or cisplatin and other platinum-based drug or have a history of severe allergies;
  • Any unresolved toxicities from prior anti-tumor therapy (including radiotherapy) greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1(except for alopecia or other adverse reactions judged no safety risk by the investigators);
Show all 18Show fewer
  • Patients with clinical symptoms of central nervous system metastases or meningeal metastases, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and the investigators judge that they are not suitable for enrollment;
  • The patient has active infectious disease;
  • The patient has a history of autoimmune disease, immunodeficiency, including positive HIV test, or has other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
  • Active hepatitis B (hepatitis B virus titer > 1000 copies/mL or 200 IU/mL), prophylactic antiviral therapy other than interferon is allowed; hepatitis C virus infection;
  • Patients with a history of severe cardiovascular disease, or severe renal dysfunction, bone marrow insufficiency, chickenpox, herpes zoster, gout, hyperuricemia, or a history of other serious systemic diseases, as judged by the investigator who are not suitable to participate in clinical trials;
  • Known alcohol or drug dependence;
  • Patients with ototoxicity (except high-frequency elderly hearing loss) or other neurotoxicity ≥ grade 2 assessed by audiometer;
  • Patients with known visual impairment who are deemed unsuitable for participation in this study by the investigator;
  • Previous history of clear neurological or psychiatric disorders, including epilepsy or dementia;
  • Pregnant or breastfeeding females;
  • Patients with history of other malignancies within 3 years before the first use of the investigational drug, except for the following: cured basal cell or squamous cell skin cancer, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc. locally curable cancer, or persistent disease-free survival within 3 years;
  • The investigator believes that the patients are not suitable to participate in this clinical study for other reasons.

Trial locations and contacts

1 site in 1 country.

Xianying Piao, doctor contact

+86-17813168890

piaoxianying@mail.ecspc.com

China1 site

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Ying Cheng, chief physician, 15044044052, 1165095416@qq.com

    Ying Cheng, doctor

Other trials in China

About this study

Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of Cisplatin Micelle Injection (HA132) in Patients With Advanced Malignant Solid Tumors

This is a multicenter, open-label, dose-escalation, dose-expansion, and cohort-expansion Phase I/II clinical study to evaluate safety, tolerability, pharmacokinetics, antitumor efficacy and to determine the maximum tolerated dose (MTD) and recommended Phase 2 doses (RP2D) of cisplatin micelle injection in patients with advanced malignant solid tumors. This study is divided into two stages, the first stage (stage I) is the dose escalation and dose expansion study of cisplatin micelle injection, to determine the maximum tolerated dose (MTD), and to initially explore the recommended dose of phase II clinical practice (RP2D). The second stage (stage II) is the cisplatin micelle injection cohort expansion study to evaluate the efficacy and safety of cisplatin micelle injection (HA132) in patients with advanced solid tumors.

Being tested
Cisplatin micelle injection (HA132)

What participants receive

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

  • Cisplatin micelle injection (HA132)Drug

    HA132 will be administered intravenously (IV), once per 3 weeks.

Study groups in NCT05478785
Study groupRoleWhat they receive
Cisplatin micelle injection (HA132)ExperimentalDose-escalation: Five dose levels have been selected for evaluation in the Phase Ⅰ of the study. Dose escalation decisions will be determined based on toxicities observed during the first cycle. Dose-expansion: Patients will be administered HA132 at one or two dose levels (e.g. MTD and the dose below MTD). Cohort-expansion: Patients will be administered HA132 at one or two dose levels (e.g. MTD and the dose below MTD).
Receives: Drug: Cisplatin micelle injection (HA132)

What is being measured

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

  1. Incidence of Dose-limiting Toxicities (DLTs) in Stage I

    Measured: Day 1 to 21 of Cycle 1 (each cycle of 21 days).

  2. Incidence of adverse events in Stage I

    Patients will be assessed for incidence and severity of adverse events(AEs) according to NCI-CTCAE criteria.

    Measured: From Baseline (Day 1) up to 28 days post last dose.

  3. Maximum tolerated dose (MTD) in Stage I

    Measured: Day 1 to 21 of Cycle 1 (each cycle of 21 days).

  4. Recommended phase 2 dose (RP2D) in Stage I

    The RP2D will be determined based on safety data including DLT, preliminary efficacy data,and PK data.

    Measured: Day 1 to 21 of Cycle 1 (each cycle of 21 days).

  5. Objective Response Rate (ORR) in stage Ⅱ

    Proportion of patients whose best overall response is CR or PR in studies assessed according to RECIST v1.1.

    Measured: Up to approximately 2 years.

  6. Confirmed objective response rate (ORR) in stage Ⅱ

    During the study period, the best overall response is the proportion of patients with confirmed CR or PR (ie, CR+PR) as assessed by Response Evaluation Criteria in Solid Tumors.(RECIST v1.1).

    Measured: Up to approximately 2 years.

Secondary outcomes (8)

  1. PK Indicator: Area under plasma concentration vs time curve(AUC)、Peak plasma concentration(Cmax)、Terminal Half Life（T1/2）.

    Measured: Day 1 of Cycle 1 up to Day 1 of Last Cycle.

  2. ORR in Stage I

    Measured: Up to approximately 2 years.

  3. Confirmed ORR in Stage I

    Measured: Up to approximately 2 years.

  4. Progression-free survival (PFS)

    Progression-free survival is defined as the time from the patient's first dose of study treatment (HA132) to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 2 years.

  5. Disease control rate (DCR)

    Proportion of patients whose best overall response is CR, PR or SD in studies assessed according to RECIST v1.1.

    Measured: Up to approximately 2 years.

  6. Duration of response (DOR)

    The DOR for a responder is defined as the time from the patient's initial objective response to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 2 years.

  7. Incidence of Adverse Events and Serious Adverse Events (SAEs) in stage Ⅱ

    Measured: Up to approximately 2 years.

  8. Estimated glomerular filtration rate (eGFR) and creatinine clearance

    Measured: Up to approximately 2 years.

Timeline

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

  1. First posted28 Jul 2022
  2. Study startAug 2022 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionAug 2025 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478785
Sponsor's protocol ID
HA132C-01
Status last verified
Jul 2022
First submitted
26 Jul 2022
Last updated
29 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cisplatin micelle injection (HA132) in people with Advanced Malignant Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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 19 inclusion and 18 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 29 Jul 2022. 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 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?

Results are not available in the source record.

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

Contact Xianying Piao, doctor (+86-17813168890, piaoxianying@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose-limiting Toxicities (DLTs) in Stage I (time frame: Day 1 to 21 of Cycle 1 (each cycle of 21 days).). The study lists 6 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 NCT05478785.

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 29 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in