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Recruitment on holdLast updated: 23 January 2024

ACT001: This phase I trial is evaluating the study drug ACT001 in patients with advanced (solid) cancersA phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of ACT001 in patients with advanced solid tumors

Clinical summary

Summary

The primary purpose of this study is to evaluate the safety of a new cancer drug, ACT001 which has not yet been tested in humans. The study will also look at the amount of drug in the blood to evaluate the way the body processes the drug and the way the drug acts on the growth of tumours in cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with advanced or metastatic solid tumor, including glioblastoma, with no standard treatment options. Study details All participants in this study will receive a specified dose of ACT001 each day for 56 days (two 28 day cycles). The first set of participants will start on the lowest dose level, with the next highest dose only commencing in the next set of participants once the safety of the first dose has been confirmed. Researchers will take a number of blood samples on days 1, 2, 3, 17, 18 and 29 of dosing in each participant to examine the rate that the body processes the drug. Further blood samples, as well as CT and MRI scans will be taken before treatment and at the end of treatment to look for changes in tumour growth. Participants will also be assessed for side effects throughout the study period. It is hoped that the findings of this trial will show whether ACT001 can be safely given to cancer patients, and provide information on the rate of processing of the drug in the body. Using this information, researchers hope to find the best dose to use for further testing of ACT001 in cancer patients.

Conditions

This trial is treating patients with advanced cancers (excluding blood cancer)

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

ACT001

More information

Trial Identifiers

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Trial sponsor

Accendatech AU Pty Ltd

Scientific Title

A phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of ACT001 in patients with advanced solid tumors

Eligibility

Inclusion

 

1. Histologically or cytologically confirmed advanced or metastatic solid tumor, including glioblastoma, with no standard treatment options.
2. Patients with recurrent glioblastoma who satisfy all of the following may be enrolled:
- Progressive tumor despite prior treatment with radiation therapy and temozolomide.
- Measurable disease by Response Assessment in Neuro-Oncology (RANO) criteria using gadolinium-enhanced MRI scanning.
- Either on no glucocorticoids or on a stable dose for 7 days prior to the first dose of study therapy.
- No evidence of intracranial hemorrhage (except for stable grade 1 hemorrhage), not receiving therapeutic anticoagulation or anti-platelet therapy, and have a normal INR and APTT.
- No prior treatment with bevacizumab or other antiangiogenic drugs.
- No radiation in the past 3 months.
3. Male or female and at least 18 years of age.
4. Adequate organ function (ANC more or equal to 1.5 x 10 to the power of 9 /L, platelets more or equal to 75 x 10 to the power of 9 /L, Hb more or equal to 10 g/dl; total bilirubin less or equal to 1.5 times the institutional upper limit of normal (ULN); ALT and AST less or equal to 2.5 times ULN (less or equal to 5.0 times ULN if liver metastasis); plasma creatinine less or equal to 1.5 times ULN;QTc less than 450 ms (male), less than 470 ms (female).
5. A life expectancy of at least 12 weeks.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
7. Female subjects are eligible if they are of:
a) Non-childbearing potential, defined as
- Previous hysterectomy or bilateral oophorectomy.
- Previous bilateral tubal ligation.
- Post-menopausal (total cessation of menses for at least 1 year).
b) Childbearing potential with a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), and uses adequate contraception before study entry and throughout the study until 28 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:
- Vasectomized partner who is sterile prior to the female patient’s enrolment and is her sole sexual partner.
- An intrauterine device with a documented failure rate of less than 1% per year.
- Double barrier contraception defined as condom with a female diaphragm.
8. Male patients, if sexually active, must agree to use a highly-effective method of contraception (< 1% failure rate per year) with their female partners.
9. Provided written informed consent prior to enrollment.

Exclusion

1. The subject has uncontrolled infection.
2. The subject has serious diseases such as unstable angina pectoris, myocardial infarction in the past 6 months, heart failure (New York Heart Association class more than II) or stroke within 6 months prior to the enrollment.
3. A gastrointestinal absorption disorder that would limit the bioavailability of an oral medication or cannot take oral drugs.
4. Uncontrolled brain metastases or spinal cord compression. Patients who were treated with surgical resection or radiation therapy completing at least 4 weeks earlier are eligible if they are neurologically stable, not taking glucocorticoids and have a follow-up MRI scan performed within the previous 4 weeks showing no tumor progression.
5. Pre-existing allergy to ACT001 or related compounds.
6. Treatment with other cancer therapies such as chemotherapy, biological or targeted therapy, immunotherapy or radiation therapy either currently or within 4 weeks of ACT001 dosing (6 weeks for BCNU, CCNU or mitomycin-C). An exception is focal radiation for symptomatic bone metastases, which must not be within 2 weeks of ACT001 dosing.
7. Unresolved toxicity from prior anti-tumour therapy, defined as toxicities (excluding alopecia) that have not resolved to less than grade 2 as scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Exceptions may be allowed for stable toxicities after discussion with the investigator and sponsor.
8. Major surgery within 30 days of commencing first study therapy.
9. Pregnant or breast-feeding females.
10. A history of infection with HIV or hepatitis B or C viruses
11. The subject has participated in other drug clinical trials less than 4 weeks prior to obtaining the informed consent.
12. The subject is, in the opinion of the investigator, unsuitable for any reason.

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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