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Closed (no longer recruiting)Last updated: 8 December 2023

This Phase I trial is evaluating how safe and effective different doses of a new targeted cancer drug (Auceliciclib) is in people with advanced solid cancers, or when given in combination with chemotherapy (temozolomide) in people with glioblastoma multiformeA Phase 1a/b, open-label, dose-exploration, combination/ expansion study to evaluate the safety, tolerability and pharmacokinetics of Auceliciclib in advanced solid tumours and in combination with temozolomide in recurrent or newly diagnosed Glioblastoma multiforme (GBM)

Clinical summary

Summary

This is a non-randomised trial with Dose Exploration and Disease Expansion phases. In the Dose Exploration phase, one cohort will be recruited sequentially for each dose level. All participants receive each dose in the Dose Exploration Phase until the maximum tolerated dose is reached. The Dose Exploration Phase involves participants with solid tumours. In the Disease Expansion Phase, there are three arms: Arm 1 involves those with ovarian cancer, Arm 2 involves those with colorectal cancer, and Arm 3 involves those with glioblastoma multiforme (GBM). For Dose Exploration and Disease Expansion (Arms 1 & 2) phases, Auceliciclib oral capsules will be administered daily for 21 days of each cycle. For Disease Expansion phase (Arm 3), Auceliciclib will be administered daily for 16 days of each cycle and Temozolomide will be administered for 5 days of each cycle.

Conditions

This trial is treating patients with advanced solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Aucentra Therapeutics Pty Ltd.

Scientific Title

A Phase 1a/b, open-label, dose-exploration, combination/ expansion study to evaluate the safety, tolerability and pharmacokinetics of Auceliciclib in advanced solid tumours and in combination with temozolomide in recurrent or newly diagnosed Glioblastoma multiforme (GBM)

Eligibility

Inclusion

1. Ability to understand and be willing to sign an informed consent form.
2. Male or female, greater than or equal to 18 years old at the time of screening.
3. Diagnosis of histologically or cytologically confirmed:
a. Locally advanced or metastatic cancer (all solid tumours) OR
b. Locally advanced or metastatic cancer OR
c. High-grade glioma, such as GBM. Patient must also:
i. Have completed radiation therapy, with concomitant TMZ plus a minimum of 1-3 full cycles of TMZ monotherapy post RTx/CTx as their SOC first-line treatment..
ii. Have recurrent/progressive high-grade glioma >/= 3-6 months post first-line SOC treatment.
4. ECOG performance status of 0 to 2.
5. Able to take oral medications.
6. QTc </= 460 msec (for Females), QTc </= 450 msec (for Males).
7. Evidence of adequate cardiac function.
8. Evidence of adequate hepatic function at screening.
9. Adequate haematology laboratory assessment at screening.
10. Adequate renal function.
11. Adequate coagulation laboratory assessments at screening.
12. Female patients must
a. Be of non-child-bearing potential, or
b. If of child-bearing potential, must agree not to attempt to become pregnant.
13. Males patients must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception
14. Estimated life expectancy of at least 3 months, in the opinion of the Investigator.
15. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion

1. Prior treatment with a CDK4/6 inhibitor, unless first approved by medical monitor.
2. Patients with symptomatic primary central nervous system (CNS) tumour, symptomatic CNS metastases, or untreated spinal cord compression that have moderate or severe symptoms.
3. Uncontrolled pleural effusion(s), pericardial effusion or ascites. Evidence of abnormal cardiac function Unable to swallow oral medications.
4. Evidence of abnormal cardiac function.
5. Unable to swallow oral medications.
6. Gastrointestinal (GI) conditions that, in the opinion of the Investigator, could affect the absorption of study drug.
7. History of other malignancy within the past 2 years.

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • 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.
Message

Clinical trials have complex eligibility criteria.

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

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